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Tuesday Mar 16, 2010
New Treatment Approved to Straighten Clenched Fingers
Xiaflex was approved by the FDA last month for the treatment of Dupuytren's contracture, a condition that affects a person's ability to straighten and use their fingers...

Friday Mar 12, 2010
Long-term Bisphosphonate Use May Actually Increase Fracture Risk
The osteoporosis drugs may boost bone quantity at the expense of bone quality, eventually weakening users' bones...

Wednesday Mar 10, 2010
Anti-Nausea Drug Eases Bone Marrow Transplants
Aprepitant, taken in combination with other anti-nausea drugs, can significantly ease the experience of a bone marrow transplant, which generally causes severe nausea and vomiting...

Wednesday Mar 03, 2010
Patients Speak Out About the Pain of Fibromyalgia
Sometimes the best way to learn about a disease is to listen to the patients who suffer from it...

Wednesday Feb 10, 2010
FDA Wants to Reduce Radiation Exposure from Medical Scans
Widespread use of CT scans and fluoroscopy is exposing some patients to unnecessary amounts of radiation, and raising their risk of cancer...

Tuesday Feb 02, 2010
UCB to Exit the Primary Care Market in the US
Instead, the company plans to focus on becoming a patient-centric global biopharmaceutical leader...

Thursday Jan 28, 2010
Pain Pumps May Lead to Development of Chondrolysis
Hundreds of patients have developed the relatively rare ailment after the use of postsurgical pain pumps...

Tuesday Jan 26, 2010
FDA Approves Tocilizumab for Refractory RA
Tocilizumab (Actemra) has been approved for adults with moderate-to-severe RA who have not achieved adequate response with other TNF therapies...

Thursday Nov 19, 2009
French Government Buys Into Naproxinod
NicOx has submitted an NDA for naproxinod for osteoarthritis, and is raising $149 million for the launch...

Wednesday Nov 18, 2009
FDA Wants Pain Pump Label Warnings
Chondrolysis follows continuous intra-articular local anesthetic infusion, FDA says...

Tuesday Nov 03, 2009
Naproxen/Nexium Combo Prevents Ulcers in OA Patients
Combining naproxen esomeprazole magnesium relieves OA pain while protecting the stomach...

Wednesday Oct 28, 2009
Third RA Patient Has PML After Rituximab
The FDA's MedWatch warning system reports that a third rheumatoid arthritis (RA) patient treated with Genentech's Rituxan (rituximab) has developed PML, this time without prior anti-TNF exposure...

Monday Oct 19, 2009
Denosumab Approval Faces Delay
FDA-watchers predict that the agency will miss the October 19th target set for denosumab approval by as much as 3 months...

Friday Oct 02, 2009
NicOx Files Naproxcinod NDA, the first CINOD for OA
NicOx has filed an NDA for naproxcinod, the first in the new class of cyclooxygenase-inhibiting nitric oxid donators (CINODs) for OA treatment...

Wednesday Sep 30, 2009
FDA Finally OKs Stelara for Psoriasis
The FDA has approved Centocor's Stelara (ustekinumab) for moderate to severe psoriasis...

Wednesday Sep 16, 2009
Thunder God Vine Trounces Sulfasalazine in RA
An extract of the traditional Chinese medicinal vine Tripterygium wilfordii Hook F (TwHF) was better than sulfasalazine for treating rheumatoid arthritis...

Wednesday Aug 05, 2009
Black Box Added to TNF Inhibitors for Kids, Teens
The FDA has expanded TNF blocker “black box” warnings to include lymphoma and other cancers in children and teens, leukemia in all patients, and new-onset psoriasis...

Tuesday Aug 04, 2009
FDA Spikes Pegloticase Gout OK
Savient Pharmaceuticals' shares tanked on the FDA's refusal to approve Krystexxa™ for gout...

Thursday Jul 23, 2009
Gene Therapy Cleared in RA Patient Death
The vector used in an RA gene therapy study did not cause the death of a patient who died during the trial...

Thursday Jul 02, 2009
FDA Panel Recommends a Lower Maximum Daily Dose of Tylenol
A panel of experts assembled by the US FDA has recommended that the daily maximum dose of acetaminophen (Tylenol) be lowered to prevent liver damage...

Wednesday Jul 01, 2009
Masitinib Pilot Study Shows Promise in DMARD-resistant RA
The first drug to target mast cells in RA shows promising early results in an uncontrolled phase 2a trial...

Tuesday Jun 30, 2009
Assessment of Bone Growth Stimulator Is Mixed
Bone-morphogenic protein (BMP) is being increasingly used in the US to stimulate the creation of new bone during spinal fusion surgery, despite higher costs and complication rates...

Tuesday Jun 23, 2009
MMF Effective, Safe for Proliferative as well as Membranous Lupus Nephritis
Mycophenolate mofetil (CellCept) may be as effective as, yet safer than, cyclophosphamide for the proliferative lupus glomerulonephritis...

Monday Jun 15, 2009
Waxman Wants to Let FDA OK Biosimilars Without Legal Authority
Rep. Henry Waxman asks White House to let FDA approve generic biologics...

Friday Jun 05, 2009
FDA OKs 2-Year Reclast for Osteoporosis
Reclast (zoledronic acid) injection has been approved as the first therapy to prevent osteoporosis for 2 years with a single dose...

Friday May 29, 2009
NIH Pops $24M into Orphan Diseases Research
NIH will put $24 million into a new program for developing drugs for rare and neglected diseases...

Friday May 15, 2009
FDA Going Back for Second Look At Menaflex
The US FDA, responding to criticism about the Menaflex approval process, is planning to take another look...

Thursday May 14, 2009
FDA OKs UCB's Cimzia for Moderate to Severe RA
Cimzia^® (certolizumab pegol), the only pegylated anti-TNF, has been approved for use in the US...

Wednesday Apr 29, 2009
Simponi Approved in US for RA, PsA, AS
The US Food and Drug Administration this week joined Canada's drugs agency in approving Simponi (golimumab) for moderate to severe RA, active PsA, and active ankylosing spondylitis...

Wednesday Apr 08, 2009
FDA Warns Pharma on "Sponsored Links"
FDA has warned 14 pharmaceutical companies about the brief ads that accompany internet search results...

Monday Mar 30, 2009
Hyaluronic Acid Not Useful in Hip OA
A single injection of hyaluronic acid was no better than placebo for hip OA...

Friday Mar 27, 2009
Fablyn^® OK'ed in EU for Osteoporosis, Still on Hold in US
Pfizer-Ligand's Fablyn^® (lasofoxifene) has been approved by European regulators, just months after failing to win FDA approval in the US...

Thursday Mar 19, 2009
Actemra Blamed for 15 Deaths in Japan
Actemra (tocilizumab, Roche/Chugai) may have caused 15 deaths in RA patients treated in Japan over the past 10 months...

Thursday Mar 05, 2009
First Nonsurgical Dupuytren's Rx Likely to Be Auxilium's Xiaflex
Auxilium Pharmaceuticals is requesting expedited approval for Xiaflex™ (clostridial collagenase for injection), a nonsurgical treatment for Dupuytren's contracture...

Thursday Feb 19, 2009
Raptiva^® Pulled in EU After 3rd PML Case; FDA Warns US Docs
European regulators suspended sales of the psoriasis drug Raptiva^® after a 3rd PML death, and the FDA warned US doctors of a 4th suspected case...

Monday Feb 16, 2009
FDA Gives Nod to Uloric^® (febuxostat), First New Gout Treatment in 40 Years
The US FDA approved 40 mg and 80 mg doses of Takeda Pharmaceutical's febuxostat (Uloric) for the chronic management of hyperuricemia in patients with gout...

Friday Feb 06, 2009
Galderma's Vectical™ Gets FDA OK for Psoriasis
Vectical vitamin D3 ointment has been approved by the FDA for mild-to-moderate plaque psoriasis...

Thursday Feb 05, 2009
Low Back Pain Seldom Needs Surgery
Patients with discogenic low back pain can be advised to get out of bed, get some exercise, and assume that they will not need surgery...

Wednesday Jan 21, 2009
FDA Grounds Pfizer's Fablyn Osteoporosis Drug
Pfizer's Fablyn (lasofoxifene) is still on hold as FDA seeks more safety data...

Friday Jan 16, 2009
FDA Backs Savella for Fibromyalgia
FDA has approved Cypress Bioscience's Savella for fibromyalgia pain, function, and well-being...

Monday Jan 12, 2009
Do FDA Statin Ad Rules Make Patients Fear Myopathy?
Statins cause no more muscle problems than placebo, so why do so many patients (and some physicians) worry?...

Tuesday Dec 16, 2008
Osteoporosis Drug Seems to Shrink Breast Tumors
Zoledronic acid (Zometa), used to treat osteoporosis patients, also appears to shrink tumors in breast cancer patients who have undergone chemotherapy…

Thursday Dec 11, 2008
One-Shot Synvisc Gets FDA Panel OK
An FDA advisory panel has unanimously recommended approval of Genzyme's Synvisc-One™ single-dose hyalin for knee OA pain...

Monday Dec 08, 2008
Medtronic Challenges Lawsuit Over Spinal Implant
The family of a woman who died after having neck surgery with Infuse Bone Graft is suing Medtronic, the maker of the spinal implant, for promoting off-label use of their device...

Thursday Dec 04, 2008
FDA Panel Okays Febuxostat for Gout
A US FDA panel voted 12-0 this week to recommend approval of Takeda Pharmaceutical's febuxostat (Uloric^®), the first new gout drug in 40 years...

Monday Nov 24, 2008
New OA Topicals Ease Pain, Protect Stomach
New topical NSAID formulations relieve OA pain without the GI problems associated with oral NSAIDs...

Friday Nov 21, 2008
EntreMed Reports Antiangiogenic Role of 2ME2 Demonstrated in RA Models
Preclinical results for 2ME2 (Panzem^® or 2-methoxyestradiol) in rheumatoid arthritis demonstrated that 2ME2 involutes rat collagen-induced arthritis and suppresses synovial VEGF and bFGF gene expression...

Thursday Nov 20, 2008
FDA Says Bisphosphonates Do Not Cause Atrial Fibrillation
The FDA has concluded that there is no causal link between the use of bisphosphonates and atrial fibrillation...

Tuesday Nov 18, 2008
Centocor's Golimumab Gives Durable Skin, Joint Relief in Psoriatic Arthritis, ACR Studies Say
More than half of active psoriatic arthritis patients receiving subcutaneous injections of 50 mg or 100 mg of golimumab (CNTO 148) every 4 weeks showed improvements that lasted through 1 year in the joint and skin symptoms...

Friday Nov 14, 2008
Salix's APRISO™ Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis
Apriso is a locally-acting aminosalicylate (5-ASA) and is the first and only mesalamine product approved by the FDA for once-a-day dosing for the maintenance of remission of UC in adults...

Wednesday Nov 12, 2008
Pegloticase Offers Hope to Patients With Worst Types of Gout
Pegloticase (Puricase^®, Savient Pharmaceuticals, Inc.) performed well in two Phase III studies...

Monday Nov 10, 2008
Lilly Reports European CHMP Adopts Negative Opinion on Cymbalta^® for the Treatment of Fibromyalgia
The European CHMP has adopted a negative opinion on a Cymbalta^® (duloxetine hydrochloride) application for the treatment of fibromyalgia, recommending the refusal of a change to the marketing authorization for Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules...

Monday Oct 27, 2008
JAMA Biologicals Safety Data Show Impact of What Supreme Court Will Decide in Wyeth v Levine
Nearly one-quarter of biological drugs wind up with additional health warnings within a few years of reaching the market. Experts say this illustrates the importance of a coming US Supreme Court decision on whether FDA approval shields companies from liability for harm caused by approved agents and devices...

Friday Oct 17, 2008
UCB’s Cimzia^® (certolizumab pegol) Reduces Intestinal Lesions and Induces Endoscopic Improvement in Crohn's Patients
A large study investigating endoscopic improvement in Crohn's disease (CD) demonstrated that Cimzia^® (certolizumab pegol), the only PEGylated anti-TNFα biologic, significantly improved endoscopic lesions and induced endoscopic response...

Thursday Oct 16, 2008
Novartis Reports Once-Yearly Aclasta^® Approved in EU to Treat Osteoporosis in Men; Label to Include Reduction of New Fractures Following Hip Fracture in Men and Postmenopausal Women
The European Commission followed the US FDA in approving once-yearly Aclasta for the treatment of osteoporosis in men who are at increased risk of fractures, and has broadened the drug’s label to include reduction of new fractures in men and postmenopausal women with osteoporosis who have recently suffered a hip fracture...

Wednesday Oct 15, 2008
Genentech Issues Dear Healthcare Provider Letter Regarding Case of PML in a Psoriasis Patient Under Long-Term Treatment With Raptiva^®
The 70-year old patient had received Raptiva^® (efalizumab) for >4 years to treat chronic plaque psoriasis before being diagnosed with progressive multifocal leukoencephalopathy...

Wednesday Oct 01, 2008
Roche Says US FDA Issues Complete Response Letter for Actemra^® Biologics License Application; No New Clinical Studies Requested
Actemra^® (tocilizumab) is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adults with moderate-to-severe rheumatoid arthritis...

Thursday Sep 25, 2008
Centocor’s Ustekinumab Demonstrates Superior Efficacy to Enbrel^® (Etanercept) in Treatment of Moderate-to-Severe Plaque Psoriasis
Greater proportion of patients receiving ustekinumab achieved significant skin clearance versus patients receiving Enbrel...

Wednesday Sep 24, 2008
Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial of ALO-01 (Embeda™) Capsules for Pain Relief in Patients With OA
If approved by the US FDA, ALO-01 would be the first opioid medicine to provide a pharmacologic abuse-deterrent feature while effectively treating patients with chronic pain...

Friday Sep 12, 2008
Breaking News: FDA Warns About Fatal PML in RA Patient Taking Rituxan^®
FDA issued a MedWatch warning reporting the first fatal PML case in a patient taking Rituxan for RA...

Thursday Sep 11, 2008
Total Ankle Replacements are Coming Into their Own—Finally
Total ankle replacements are expected to soon rival hip and knee replacements in design, function, and durability. Airbags and seatbelts contribute to growing demand…

Tuesday Sep 09, 2008
FDA Posts List of Potential Problem Drugs
The FDA has posted a list of prescription drugs that are under investigation for potential safety problems…

Monday Sep 08, 2008
FDA Warns of Histoplasmosis, Invasive Fungal Infections in Patients Taking TNF Inhibitors
The US Food and Drug Administration has issued a “MedWatch” warning about the risk of histoplasmosis and other invasive fungal infections in patients taking TNF blockers...

Thursday Aug 28, 2008
Mesoblast Reports Preclinical Study Shows Allogeneic Stem Cells in Ewes are Safe, Effective for Cervical Spine Fusion; Therapy May Receive Boost From US FDA’s Recent Alert of Life-Threatening Complications Associated With rhBMP in Cervical Spine Fusions
Mesoblast is currently in phase II clinical trials for fusion of the lumbar spine and, based on these new results, will extend its market opportunity to cover the entire spectrum of spinal fusion. Subject to FDA approval, Mesoblast's therapy will eliminate the need for autograft...

Wednesday Aug 27, 2008
Pivotal Humira Trial Shows Durable Benefit in Juvenile Rheumatoid Arthritis
The pivotal trial of adalimumab (Humira^®) shows durable, safe efficacy for up to 2 years for children with polyarticular JRA and positions the TNF-inhibitor as the reasonable second-line drug to add if methotrexate does not provide sufficient disease control...

Tuesday Aug 26, 2008
After Fits and Starts, New Hope for Psoriasis Patients
Psoriasis patients are finally finding some relief with a new wave of drug treatments known as biologics…

Thursday Aug 21, 2008
Mesoblast Reports Stem Cells Regrow Knee Cartilage in Postmenopausal Ewes With OA; Repair Nonhealing Bones in Humans
Mesoblast, a regenerative medicine company developing treatments for orthopaedic conditions, announced successful preclinical trial results showing that its proprietary adult stem cells regenerated and regrew damaged knee cartilage...

Tuesday Aug 19, 2008
Centocor Says US FDA Extends Review by 3 Months for Ustekinumab’s (CNTO 1275) Biologic License Application to Treat Plaque Psoriasis
Centocor filed an application with the FDA for ustekinumab in late 2007 seeking approval to market the drug to treat adult patients with chronic moderate-to-severe plaque psoriasis...

Thursday Aug 14, 2008
Are More Vioxx-Like Drug Catastrophes Inevitable?
Sociologist predicts growing numbers of drug safety disasters because of fatal flaws in the way new drugs are tested and marketed…

Tuesday Aug 05, 2008
Proposed Bill Would Finalize Sunscreen Labeling Rules
Two US Senators have introduced a bill designed to compel the FDA to make a set of proposed rules on sunscreen labeling final…

Friday Aug 01, 2008
Roche Reports US FDA Advisory Committee Recommends Approval of Actemra^®; if Approved, Would Be First IL-6 Inhibitor for the Treatment of RA
Hoffmann-La Roche announced that the Arthritis Advisory Committee of the US FDA recommended approval of Actemra^® (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting humanized monoclonal antibody...

Wednesday Jul 30, 2008
Ore Pharmaceuticals Files IND Application With US FDA for GL1001, a Nanomolar Inhibitor of ACE2, to Treat IBD
GL1001, an orally administered small molecule, is the first clinical-stage inhibitor of the ACE-related carboxypeptidase (ACE2), a membrane-associated and secreted enzyme expressed predominantly on endothelium...

Tuesday Jul 22, 2008
Ardea Biosciences Advances RDEA806 Into Phase IIa Proof-of-Concept Study for Gout
Ardea Biosciences has received regulatory approval to begin a phase IIa proof-of-concept clinical trial evaluating RDEA806 in gout patients with hyperuricemia...

Friday Jul 11, 2008
FDA Warns of Tendonitis, Tendon Rupture Risk With Certain Antibiotics
Fluoroquinolones get black box warning due to increase risk of tendonitis and tendon rupture…

Monday Jul 07, 2008
UCB’s Cimzia^® Filed With EMEA for Treatment of RA: if Approved, Would be First and Only PEGylated, Fc-Free Anti-TNFα Biologic
UCB has submitted an MMA for approval of Cimzia^® (certolizumab pegol) as a subcutaneous treatment for adults with moderate-to-severe active rheumatoid arthritis...

Thursday Jul 03, 2008
Centocor Requests Approval From FDA of Golimumab for the Treatment of RA, Psoriatic Arthritis, and Ankylosing Spondylitis
Centocor submitted a Biologics License Application to the US FDA requesting the approval of golimumab, a human anti-TNFα monoclonal antibody, as a monthly subcutaneous treatment for adults with active forms of RA, PsA, and AS...

Thursday Jun 26, 2008
Otsuka, UCB to Codevelop and Copromote Cimzia^® in Japan for Crohn's Disease
UCB and Otsuka Pharmaceuticals have agreed to copromote UCB's anti-TNFα drug Cimzia^® for the treatment of Crohn's Disease in Japan, the second largest pharmaceutical market in the world...

Tuesday Jun 17, 2008
Cymbalta^® Approved for Fibromyalgia
The antidepressant Cymbalta^® (duloxetine) has been approved by the US FDA to treat fibromyalgia…

Monday Jun 16, 2008
Belimumab is Back: New Criteria Show Activity in SLE
The humanized monoclonal antibody belimumab showed significant activity in the extension of a phase II clinical trial for SLE as measured by new, FDA-approved assessment criteria...

Friday Jun 13, 2008
60-Week Safety Data Reassuring for Duloxetine in Fibromyalgia
Duloxetine is safe and tolerable for long-term use in the treatment of fibromyalgia (FM)...

Wednesday Jun 11, 2008
Merck Announces Initiation of Second Phase II/III Pivotal Clinical Study of Atacicept in SLE
Merck and development partner ZymoGenetics have initiated a phase II/III trial of atacicept (formerly TACI-Ig) in patients with systemic lupus erythematosus (SLE). Atacicept inhibits the two growth factors BLyS and APRIL that are known to impact disease progression...

Tuesday Jun 10, 2008
Novartis’ Once-Yearly Reclast^® Injection 5 mg Receives Revised US Label; Indication to Include Prevention of Fractures After a Hip Fracture
The FDA has broadened the indication for once-yearly Reclast^® (zoledronic acid) for postmenopausal osteoporosis to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture...

Monday Jun 09, 2008
FDA Launches Major Investigation of Cancer Risk in Children Taking TNF Blockers
The FDA is investigating a possible link between TNF blockers and cancer in children and young adults...

Monday Jun 09, 2008
Jazz Pharmaceuticals Completes Enrollment in First of Two Phase III Clinical Trials of Sodium Oxybate (Xyrem^®) to Treat FMS
Jazz Pharmaceuticals, a specialty pharmaceutical company, announced completion of enrollment in the first of two phase III pivotal clinical trials of JZP-6 (sodium oxybate, Xyrem^®) for the treatment of fibromyalgia...

Wednesday Jun 04, 2008
Case Series Adds Support for Routine PET in Polymyalgia Rheumatica
Routine PET might be a useful option in patients with steroid-resistant polymyalgia rheumatica (PMR)...

Wednesday May 28, 2008
Wyeth Receives Approval Letter From FDA for Bazedoxifene to Treat Postmenopausal Osteoporosis
The US FDA has issued an approval letter for Wyeth's bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis...

Tuesday May 20, 2008
Warner Chilcott, LEO Pharma Report FDA Approves Taclonex Scalp^®, a Once-Daily Therapy for Treatment of Moderate-to-Severe Scalp Psoriasis
The US FDA has approved the new drug application for Taclonex Scalp^® topical suspension for the treatment of moderate-to-severe psoriasis vulgaris of the scalp in adults...

Friday May 16, 2008
Centocor Alerts Authorized Distributors and Prescribing Physicians About Stolen Infliximab (Remicade^®)
A transport trailer carrying infliximab (Remicade^®) was stolen en route to a specialty distributor on May 6, 2008...

Tuesday May 13, 2008
Osteologix’s IND for NB S101 (strontium malonate) to Treat Osteoporosis Accepted by US FDA
The US FDA has accepted Osteologix's IND application for NB S101 (strontium malonate), a dual-acting bone agent, to treat and prevent osteoporosis...

Monday May 12, 2008
Rituximab OK Following Anti-TNF-Associated TB
Rituximab is both safe and effective in rheumatoid arthritis (RA) patients who have had active TB while being treated with a TNF-α inhibitor...

Tuesday May 06, 2008
FDA Adds “Black Box” Warning About Infections to Enbrel Label
FDA has heightened warnings on the prescribing information for etanercept with regard to serious infections and has warned clinicians to screen patients for latent TB before beginning treatment...

Thursday May 01, 2008
Genentech, Biogen Idec Report Phase II/III Trial of Rituxan^® Fails to Meet Primary or Secondary Endpoints in Lupus
A randomized, double-blind, placebo-controlled, multicenter phase II/III study of Rituxan^® (rituximab) for systemic lupus erythematosus (SLE) did not meet its primary endpoint or any of the six secondary endpoints...

Thursday May 01, 2008
La Jolla Pharmaceutical Reports Positive 12-Month Interim Antibody Data From Phase III Study of Riquent^® for SLE; Significant, Sustained Reductions Observed in Antibodies to dsDNA
Analyses of data in the first 125 randomized patients indicate that for all patients treated with Riquent^® compared with placebo, there were significantly greater reductions in antibodies to double-stranded (ds) DNA...

Wednesday Apr 30, 2008
UCB Launches CIMplicity™ Program to Provide Comprehensive Treatment Support to Crohn’s Disease Patients Receiving Cimzia^® (certolizumab pegol)
UCB's new CIMplicity™ program provides Cimzia^® patients and their caregivers with comprehensive financial, administrative, compliance, and treatment support...

Friday Apr 25, 2008
FDA Approves New Once-a-Month Dose of Actonel^® (risedronate sodium) for Postmenopausal Osteoporosis
The US FDA has approved a new once-a-month dose (150 mg) of Actonel^® (risedronate sodium) tablets for the treatment and prevention of postmenopausal osteoporosis...

Thursday Apr 24, 2008
UCB’s Cimzia^® Approved in the US for the Treatment of Moderate-to-Severe Crohn's Disease; Dosed Subcutaneously Every 4 Weeks 
The US FDA has approved Cimzia^® (certolizumab pegol), indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderate-to-severe active disease who have an inadequate response to conventional therapy... 

Friday Apr 18, 2008
Novartis Announces Once-Yearly Reclast Better Than Risedronate at Increasing BMD in GIO Patients; US FDA Approval Sought for Treatment and Prevention of GIO
Novartis Pharmaceuticals Corp reported that a once-yearly infusion of Reclast^® (zoledronic acid) injection 5 mg was significantly better than risedronate at increasing BMD in patients with glucocorticoid-induced osteoporosis...

Friday Apr 18, 2008
Roche’s Actemra^® (tocilizumab) Approved in Japan to Treat Patients With RA; Represents First Approval for Actemra in RA Worldwide
Roche partner company Chugai Pharmaceutical Co, Ltd has received approval in Japan for Actemra^® (tocilizumab) 200 mg for the treatment of rheumatoid arthritis, making Japan the first market to gain access to Actemra for the treatment of RA...

Wednesday Apr 16, 2008
Neurochem to Advance Eprodisate (Kiacta™) in Second Phase III Trial for Amyloid A; Marketing Applications Withdrawn in US, EU, and Switzerland
Neurochem (International) Ltd announced that it intends to initiate a second phase III clinical for eprodisate (Kiacta™) to obtain market approval for the treatment of amyloid A (AA) because amyloidosis is a life-threatening disease for which there is no specific treatment...

Tuesday Apr 15, 2008
Novartis Says Aclasta Better at Boosting Bone Mass
Novartis reported study results indicating a once-yearly infusion of Aclasta is more effective than risedronate at increasing bone mass in patients taking steroids...

Tuesday Apr 15, 2008
JAMA Blasts Vioxx Ghostwriters, Guest Authors, and Mortality Reporting
Documents obtained during Vioxx lawsuits against Merck provide a “case-study review of industry documents” showing that most clinical trial manuscripts and review articles were written by sponsor employees with noncompany authors brought in later to disguise the work, to misleadingly report mortality data to the FDA, and to keep data from some IRBs, JAMA authors charged...

Monday Apr 14, 2008
Orencia Gets FDA Okay for JIA
Pediatric rheumatologists gained a new tool for use in treating juvenile idiopathic arthritis (JIA) with the US Food and Drug Administration’s approval of Orencia^® (abatacept)...

Friday Apr 11, 2008
FDA Warns of Progressive Multifocal Leukoencephalopathy With CellCept
FDA informed healthcare professionals that it is investigating a potential association between the use of mycophenolate mofetil and development of PML...

Tuesday Apr 01, 2008
Targeted Genetics Announces Completion of Dosing for Phase I/II Clinical Trial of tgAAC94 for Inflammatory Arthritis
Dosing has been completed for Targeted Genetic's phase I/II clinical trial of tgAAC94 administered directly to affected joints of subjects with inflammatory arthritis to reduce inflammation and to avoid the potential for systemic side effects...

Friday Mar 28, 2008
Regeneron’s Arcalyst™ (rilonacept), First and Only FDA-Approved Treatment for Cryopyrin-Associated Periodic Syndromes (CAPS); Now Available in the US
Regeneron Pharmaceuticals, Inc announced that Arcalyst™ (rilonacept) injection for subcutaneous use is now available by prescription in the US for the treatment of cryopyrin-associated periodic syndromes (CAPS)...

Tuesday Mar 25, 2008
UCB Reports That CHMP Upholds Negative Opinion on Cimzia^® (certolizumab pegol) for Crohn’s Disease
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has rejected UCB's appeal to have Cimzia^® (certolizumab pegol) approved for the treatment of Crohn’s disease patients...

Tuesday Mar 18, 2008
Genzyme Reports That US Data From Large Outcome Studies of Carticel^® Support Long-Term Clinical Duration; Prior Marrow Stimulation Techniques May Compromise Treatment With Carticel
Genzyme announced that almost 90% of patients treated with Carticel who experienced improvement in knee function at an early follow-up, sustained their improvement for almost 10 years...

Tuesday Mar 04, 2008
P&G Wins Patent Infringement Lawsuit for Osteoporosis Therapy Actonel^®; Teva to Appeal Court Ruling
Procter & Gamble announced that the US District Court of Delaware ruled in its favor in the patent infringement lawsuit the company filed against Teva Pharmaceuticals USA, Inc...

Thursday Feb 28, 2008
Tysabri May Cause Liver Damage, Health Officials Say
Tysabri, the MS drug recently approved for treatment of Crohn’s disease, can cause liver damage in as few as 6 days…

Tuesday Feb 26, 2008
Abbott Receives FDA Approval for Humira^® (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis; EOW Dosing
Abbott Laboratories announced it has received US FDA approval to market Humira^® (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis...

Monday Feb 11, 2008
UCB Reports US FDA to Review Cimzia® License Application for Treatment of RA
UCB announced that the US FDA agreed to accept a Biologics License Application for Cimzia® (certolizumab pegol), a PEGylated and Fc-free anti-TNFα antibody-fragment therapeutic, for the treatment of adult patients with active rheumatoid arthritis (RA)...

Friday Feb 08, 2008
Phase III Data Look Good for Ustekinumab (CNTO 1275) in Plaque Psoraisis
Ustekinumab (CNTO 1275), a new monoclonal antibody that blocks interleukin (IL)-12 and IL-23, may hold advantages over existing systemic therapies for chronic plaque psoriasis in terms of its convenience and potentially its safety...

Thursday Feb 07, 2008
Watson, Barr, Teva Launch Generic Fosamax® (Alendronate Sodium) Tablets
Watson Pharmaceuticals, Inc; Barr Pharmaceuticals, Inc; and Teva Pharmaceutical Industries Ltd; have announced launches of the generic version of Merck & Co, Inc's Fosamax® tablets...

Wednesday Feb 06, 2008
Trial Data Confirm Dramatic Clearing of Severe Plaque Psoriasis With Infliximab
Data from three randomized, placebo-controlled trials show substantial benefit from Remicade® (infliximab) in moderate-to-severe plaque psoriasis...

Tuesday Feb 05, 2008
Centocor Announces Ustekinumab (CNTO 1275) Biologics License Application Accepted by US FDA for the Treatment of Psoriasis
Centocor, Inc announced that the Biologics License Application for ustekinumab (CNTO 1275), a fully-human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, has been accepted for review by the US FDA for the treatment of chronic moderate-to-severe plaque psoriasis in adults...

Thursday Jan 31, 2008
Financial Ties Are Cited as Issue in Spine Study
Many of the spine surgeons who hailed the Prodisc® as a medical breakthrough had a financial interest in the new product…

Monday Jan 28, 2008
Genentech, Biogen Idec, Roche Report Rituxan® (rituximab, MabThera®) Phase III Trial Meets Study Endpoints in RA; Use as First-Line Biologic Therapy Improves Symptoms 
Genentech, Inc, Biogen Idec, and Roche Pharmaceuticals announced that a pivotal phase III study of rituximab (Rituxan®) met its primary endpoint of greater proportion of biologic-naïve RA patients achieving ACR20 response at week 24, compared with placebo...

Friday Jan 25, 2008
Low Serum Testosterone Predicts Fracture Risk in Older Men
Men with serum testosterone <294 ng/dL have a significantly increased risk of nontraumatic fracture and should be referred for bone density assessment...

Wednesday Jan 23, 2008
Abbott's Humira® Approved in US for Treatment of Moderate-to-Severe Chronic Plaque Psoriasis
Abbott Laboratories announced it has received US FDA approval to market Humira® (adalimumab) for adults with moderate-to-severe chronic plaque psoriasis...

Wednesday Jan 23, 2008
ZymoGenetics, Merck Serono Gain Special Protocol Assessment from US FDA for Atacicept (TACI-Ig) in General SLE
ZymoGenetics, Inc and its partner Merck Serono Intl has received agreement from the US FDA for studies that are intended to support an application for marketing authorization of atacicept in the US for the treatment of SLE...

Thursday Jan 17, 2008
Elan, Biogen Idec Gain US FDA Approval of Tysabri® for Treatment of Moderate-to-Severe Crohn's Disease
Elan Corp, plc and Biogen Idec announced the approval of a supplemental Biologics License Application for Tysabri® (natalizumab) for inducing and maintaining clinical response and remission in adult patients with active moderate-to-severe Crohn's disease...

Tuesday Jan 15, 2008
Anika Enrolls First Patient in US Clinical Study for Monoviscâ„¢ for Knee Joint Pain Relief; Expects Product Launch in Europe in First Half 2008 
Anika Therapeutics, Inc announced that it has enrolled the first patient in a multicenter pivotal study evaluating its single-injection osteoarthritis (OA) product, Monoviscâ„¢...

Monday Jan 14, 2008
Drug Approved. Is Disease Real?
As Pfizer markets Lyrica® (pregabalin), the first approved medicine to treat fibromyalgia, doctors debate the legitimacy of the pain syndrome...

Friday Jan 11, 2008
Judge Calls Celebrex® Evidence Unreliable
A New York state court has ruled that there is no reliable scientific evidence to prove that the pain medication Celebrex® causes heart attack and stroke…

Tuesday Jan 08, 2008
Salix Submits Granulated Mesalamine NDA to US FDA as Once Daily Dosing for Maintenance of UC Remission; Colazal® (balsalazide disodium) for UC Goes Generic
Salix Pharmaceuticals, Ltd, a developer and marketer of prescription pharmaceutical products for the treatment of gastrointestinal diseases, announced that it is seeking approval to market granulated mesalamine as a once daily treatment for the maintenance of ulcerative colitis (UC) remission in patients...

Tuesday Jan 08, 2008
FDA Warns of Severe Bone, Joint, Muscle Pain Linked to Bisphosphonates
FDA warning highlights "severe and sometimes incapacitating" musculoskeletal pain in patients taking bisphosphonates...

Monday Jan 07, 2008
Abbott's Humira® Approved in the EU for Treatment of Moderate-to-Severe Plaque Psoriasis
Abbott announced it has received marketing authorization from the European Commission for the use of the TNF antagonist Humira® (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. Humira is the first fully human, self-injectable biologic for the treatment of psoriasis...

Friday Jan 04, 2008
Neurochem's Eprodisate (Kiactaâ„¢) for the treatment of AA Amyloidosis Receives Negative Opinion from CHMP; Decision by US FDA Expected April 2008
Neurochem (International) Ltd, a wholly-owned subsidiary of Neurochem Inc, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a negative opinion recommending refusal of the marketing authorization application for eprodisate (Kiactaâ„¢) for the treatment of Amyloid A (AA) amyloidosis...

Thursday Jan 03, 2008
Forest, Cypress Submit New Drug Application for Milnacipran for the Treatment of Fibromyalgia
Forest Laboratories, Inc and Cypress Bioscience, Inc announced that they have submitted a New Drug Application (NDA) to the US FDA for milnacipran, a unique dual-reuptake inhibitor being developed for the treatment of fibromyalgia syndrome (FMS)...

Wednesday Dec 12, 2007
Ferring's Euflexxaâ„¢ (1% sodium hyaluronate) is Effective in Treating Knee OA and Reduces Pain that Interferes with ADLs; Shows Equal Effectiveness in Disease Stages Two and Three
Ferring Pharmaceuticals announced the results of two clinical studies on the efficacy of Euflexxaâ„¢, an intra-articular hyaluronic acid (IA-HA) for the relief of pain in knee osteoarthritis (OA)...

Tuesday Dec 11, 2007
Pain Therapeutics', King's Remoxyâ„¢ Meets Primary Endpoint in Pivotal Phase III Study in OA Patients with Chronic Pain; NDA Filing Expected in Mid-2008
Pain Therapeutics, Inc and King Pharmaceuticals, Inc announced that a pivotal phase III study of Remoxyâ„¢, an abuse-deterrent version of long-acting oxycodone, in osteoarthritis patients with chronic pain met the primary endpoint that was prospectively defined by the US FDA during the Special Protocol Assessment (SPA) process...

Friday Dec 07, 2007
Pfizer, Adolor Enter Into Exclusive Worldwide Collaboration to Develop and Commercialize Delta Opioid Receptor Agonists to Treat Range of Inflammatory, Neuropathic, and Acute Pain

Pfizer Inc and Adolor Corp, a leader in the area of novel, opioid receptor-targeted therapeutics, announced an exclusive worldwide collaboration to develop and commercialize delta opioid receptor agonist candidates, ADL5859 and ADL5747, for the treatment of pain...

Thursday Dec 06, 2007
Medarex Announces Acceptance by US FDA of IND Application for Wholly-Owned Fully Human Anti-CD19 Antibody, MDX-1342, for Phase I Clinical Study for RA
Medarex, Inc, a biopharmaceutical company focused on the discovery, development, and commercialization of fully human antibody-based therapeutics, announced the allowance of an investigational new drug application filed with the US FDA for MDX-1342 for rheumatoid arthritis...

Monday Dec 03, 2007
Targeted Genetics Announces That US FDA Removed Hold on Phase I/II Clinical Trial of tgAAC94 for Inflammatory Arthritis; Phase II Clinical Trial Protocol Design Underway

Targeted Genetics Corp announced that the US FDA removed the hold on the company's phase I/II clinical trial of tgACC94 for inflammatory arthritis, following the agency's review of the safety data thus far on all 127 subjects and all data from a fatal serious adverse event, which led to the death of a patient...

Friday Nov 30, 2007
Drug Update: Abatacept
Researchers continue to argue for the cost-effectiveness of abatacept in treatment-resistant rheumatoid arthritis, but a real-world analysis raises questions about responses in routine clinical use. Safety data show no increased risk of malignancies or infection...

Thursday Nov 29, 2007
Osiris Announces Clinically and Statistically Significant 1-Year Data From Phase I/II Trial of Chondrogenâ„¢; OA Knee Patients Receive Single Injection of Adult Stem Cells Into Knee
Osiris Therapeutics, Inc, a leading stem cell therapeutic company, announced positive 1-year interim results in the evaluation of Chondrogenâ„¢, a preparation of mesenchymal stem cells obtained from the bone marrow of healthy adult donors and formulated for direct injection into the knee...

Monday Nov 26, 2007
Abatacept Wins Plaudits in Refractory JIA
The costimulation blocker abatacept may be a safe and effective option for juvenile idiopathic arthritis patients who have exhausted all other therapies...

Tuesday Nov 20, 2007
Novartis Says Health Regulators in UK and Germany Suspend Marketing and Sale of Prexige® Pending Outcome of European Regulatory Review
Novartis Pharmaceuticals AG announced that health regulators in the UK and Germany have suspended the marketing and sale of Prexige® (lumiracoxib), a COX-2 inhibitor for patients with osteoarthritic pain, following a review of the drug's benefit/risk profile...

Tuesday Nov 20, 2007
Abbott's Humira® Receives Positive Opinion From EMEA for Treatment of Moderate-to-Severe Plaque Psoriasis 
Abbott Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP), granted Abbott a positive opinion recommending approval of Humira® (adalimumab) for the treatment of moderate-to-severe plaque psoriasis...

Monday Nov 19, 2007
UCB Reports that the Committee for Medicinal Products for Human Use has Denied Market Authorization in the EU for Cimzia® to Treat Crohn's Disease; UCB to Appeal
UCB Pharma SA announced that it has been informed by the European Medicines Agency that the Committee for Medicinal Products for Human Use has rejected a marketing authorization in the EU for Cimzia® (certolizumab pegol) for reducing signs and symptoms and maintaining clinical response in patients with severe, active Crohn's disease...

Tuesday Nov 13, 2007
Anti-IL-12/23 Monoclonal Produces Dramatic Results in Psoriatic Arthritis
The anti-IL-12/23 monoclonal antibody ustekinumab produced dramatic, durable improvements in psoriatic arthritis, according to phase II data reported at the American College of Rheumatology...

Tuesday Nov 13, 2007
Targeted Genetics Reports Positive Interim Phase I/II Results for tgAAC94 in Inflammatory Arthritis; Tests Indicate tgAAC94 Did Not Contribute to Immunosuppression Leading to Fatal SAE
Targeted Genetics Corp, a clinical-stage biotechnology company, announced that interim data from its phase I/II trial of tgAAC94 for inflammatory arthritis suggest that the investigational therapy showed improvement in patient-reported outcome measures...

Thursday Nov 01, 2007
Few Remissions From Switching to Other DMARDs After MTX Failure
If initial MTX fails to produce remission in RA, adding or switching to other conventional DMARDs is also unlikely to produce remissions...

Wednesday Oct 31, 2007
BREAKING NEWS: FDA Heightens Warning About Miscarriage, Birth Defects With Drug Used Off-Label for Lupus Nephritis

FDA has raised the warning level for mycophenolate mofetil (MMF) from Category C to Category D (positive evidence of fetal risk)...

Tuesday Oct 30, 2007
Novartis' Voltaren® (diclofenac) Gel Receives FDA Approval as First Topical NSAID Prescription Treatment for OA Pain of the Knees and Hands 
Novartis Pharmaceuticals AG announced that Voltaren® Gel (diclofenac sodium topical gel) 1% has received US FDA regulatory approval as the first topical nonsteroidal anti-inflammatory drug (NSAID) prescription treatment for use in treating pain associated with osteoarthritis (OA) in joints amenable to topical treatment...

Tuesday Oct 23, 2007
Experts Fret About How to Regulate "Generic" Biologics
Biopharmaceuticals are beginning to come off patent, promising cost savings for patients and headaches for regulators...

Monday Oct 22, 2007
Hollis-Eden Reports Positive Data Demonstrating That Anti-Inflammatory Agent HE3286 (Triolex^TM) Provides Benefit in Animal Models of Ulcerative Colitis and RA; Will Initiate Phase I/II Clinical Study in RA
Hollis-Eden Pharmaceuticals, Inc, a company focused on the development of a proprietary new class of small molecules that are metabolites or synthetic analogs of endogenous adrenal steroid hormones, announced additional data on drug candidate HE3286 (Triolex^TM), an orally active, second generation, synthetic 17-ethynyl derivative of the steroid hormone dehydroepiandrosterone (DHEA), currently in preclinical and clinical study for the treatment of autoimmune diseases and inflammatory disorders...

Friday Oct 12, 2007
Novartis' Aclasta® Receives EU Approval as First Once-Yearly Treatment for Postmenopausal Osteoporosis
Novartis Pharmaceuticals AG announced that Aclasta® (zoledronic acid 5 mg) has received EU approval as the first once-yearly treatment for women with postmenopausal osteoporosis...

Monday Oct 01, 2007
Novartis' COX-2 Inhibitor Prexige® Deemed "Not Approvable" by US FDA; Discussions with FDA to Continue 
Novartis Pharmaceuticals AG announced that it has received a "not approvable" letter from the US FDA for its COX-2 inhibitor Prexige® (lumiracoxib) as a once-daily treatment for patients suffering from pain due to osteoarthritis...

Wednesday Sep 26, 2007

Sucampo Pharmaceuticals Begins Phase II, Dose-Finding Trial of Cobiprostone, a Chloride-Channel Activator, for the Prevention of NSAID-Induced Ulcers in Arthritis Patients

Sucampo Pharmaceuticals, Inc, announced that it has enrolled the first patient in a multicenter, phase II, dose-finding trial evaluating the prostone cobiprostone (SPI-8811) for the prevention of ulcers and other gastrointestinal injuries in arthritis patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs)...

Thursday Sep 20, 2007
Targeted Genetics Provides Update on its Inflammatory Arthritis Phase I/II Trial on Clinical Hold Following Patient Death; Data To Date Does Not Implicate Study Agent
Targeted Genetics Corp, a clinical-stage biotechnology company, reported on the public hearing conducted by the National Institutes of Health (NIH) recombinant DNA advisory committee (RAC), which reviewed the serious adverse event (SAE) reported by Targeted surrounding the death of a patient participating in the company's phase I/II trial of tgAAC94 for inflammatory arthritis...

Thursday Sep 13, 2007
Aspreva, Roche Terminate Lupus Nephritis Development Program; Previously Reported Phase III Data Does Not Adequately Support Regulatory Submission
Aspreva Pharmaceuticals Corp announced that Aspreva and Roche have decided not to proceed with a regulatory submission at this time for CellCept (oral mycophenolate mofetil, MMF) as an induction therapy for lupus nephritis...

Friday Sep 07, 2007
Archus Orthopedics Completes World's First Lumbosacral Facet Joint Replacement 
Archus Orthopedics, Inc, a privately-held company developing reconstructive implants to treat a variety of spine disorders resulting from degenerative changes in the facet joints, announced that it has successfully completed in Europe the first human implants of its new TFAS-LS^â„¢ system, representing the first ever facet joint replacement procedures performed at the lumbosacral spinal (LS) level...

Friday Aug 31, 2007
TNF Inhibitors Raise Risk for Skin Cancers But Not Other Malignancies
The final report from a large observational study of more than 13,000 patients clears TNF inhibitors of increasing the incidence of solid tumors or lymphomas but finds that TNF-inhibitor treatment is associated with a significant increase in melanomas and other skin cancers…Wolfe F, et al. Arthritis Rheum. 2007;56:2886-2895.

Thursday Aug 30, 2007
Medtronic Receives FDA Approval for First Artificial Disc for Use in the Cervical Spine in the US
Medtronic, Inc,  announced that it has received US FDA approval to market the PRESTIGE® Cervical Disc, the first artificial disc commercially available in the US for use in cervical disc arthroplasty or cervical artificial disc replacement...

Thursday Aug 23, 2007
Lilly Seeks Approval From US FDA for Cymbalta® (duloxetine hydrocholoride) in Fibromyalgia
Eli Lilly and Co announced that it has submitted a supplemental new drug application (sNDA) to the US FDA for Cymbalta® (duloxetine hydrocholoride), a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), for the management of fibromyalgia...

Monday Aug 20, 2007
Novartis' Once-Yearly Reclast® Receives US FDA Approval for Women With Postmenopausal Osteoporosis 
Novartis Pharmaceuticals Corp announced that its once-yearly, 15-minute infusion treatment of Reclast® (zoledronic acid) injection has been approved by the US FDA for women with postmenopausal osteoporosis...

Tuesday Aug 14, 2007
Novartis Withdraws Lumiracoxib (Prexige®) in Australia in Response to Decision From Therapeutic Goods Administration to Cancel Registration
Novartis Pharmaceuticals Australia Pty Ltd announced the immediate recall of all doses (100 mg, 200 mg, and 400 mg tablets) of lumiracoxib (Prexige®), a COX-2 inhibitor for the treatment of osteoarthritis (OA) and acute pain...

Thursday Aug 09, 2007
Regeneron's Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS, a Spectrum of Rare Inherited Autoinflammatory Conditions 
Regeneron Pharmaceuticals, Inc, announced that the US FDA has accepted for filing and granted priority review status to the Biologics License Application (BLA) for rilonacept (interleukin-1 (IL-1) Trap), a potent, long-acting inhibitor of IL-1, for the long-term treatment of cryopyrin-associated periodic syndromes (CAPS)...

Wednesday Aug 08, 2007
Bristol-Myers Squibb's Orencia® (abatacept) Supplemental Biologics License Application for JIA Accepted by US FDA for Filing and Review
Bristol-Myers Squibb Co announced that the US FDA has accepted the supplemental biologics license application (sBLA) for filing and review of Orencia® (abatacept) to treat pediatric patients with juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists...

Thursday Aug 02, 2007
FDA Stops Arthritis Gene Therapy Trial After Patient Dies
CIAOMed takes an in-depth look into what went wrong in the inflammatory arthritis gene therapy trial that resulted in a patient's death and what this incident may mean for the future of gene trials, particularly in arthritis...

Tuesday Jul 31, 2007

Barrier Therapeutics Announces Positive Phase IIb Data With Oral Rambazoleâ„¢ in Moderate-to-Severe Plaque Psoriasis


Barrier Therapeutics, Inc, announced positive results from its phase IIb dose-finding study of oral Rambazoleâ„¢, an investigational all-trans retinoic acid (ATRA) metabolism blocking agent drug candidate, for moderate-to-severe plaque psoriasis.

Wednesday Jul 25, 2007
Targeted Genetics' Inflammatory Arthritis Phase I/II Trial Placed on Clinical Hold
Targeted Genetics Corp, a clinical-stage biotechnology company, announced that after recent discussions with the US FDA, the phase I/II clinical study of tgAAC94, an investigational therapy for the treatment of inflammatory arthritis, has been placed on clinical hold.

Tuesday Jul 24, 2007
Novartis Receives Positive Opinion Supporting EU Approval for Aclasta® as the First Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
Novartis Pharmaceuticals AG announced that it has been informed by the European Medicines Agency that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the marketing application for the use of Aclasta®.

Monday Jul 23, 2007
Elan, Biogen Idec to Appeal Negative Ruling on European Application for Tysabri^R for Crohn's

Elan Corporation, plc, and Biogen Idec announced that they have been informed by the European Medicines Agency that the Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing application for the use of Tysabri® (natalizumab).

Thursday Jul 19, 2007
Aspreva, Roche Report Preliminary Results for Phase III Study of CellCept in Lupus Nephritis; Fail to Achieve Primary Objective of Superiority to Intravenous Cyclophosphamide

Aspreva Pharmaceuticals Corp and Roche released preliminary results from a phase III clinical trial comparing CellCept (oral mycophenolate mofetil, MMF) with intravenous cyclophosphamide (IVC), the current standard of care in patients suffering from lupus nephritis.

Wednesday Jul 18, 2007
Neurochem Receives Second Approvable Letter From US FDA for Eprodisate (Kiactaâ„¢) to Treat AA Amyloidosis
Neurochem (International) Limited  announced that it has received a second approvable letter from the US FDA for eprodisate (Kiactaâ„¢)...

Tuesday Jul 17, 2007
NicOx Initiates Third Pivotal Phase III Study of Naproxcinod for OA of the Hip
NicOx SA, a biopharmaceutical company focused on the development of nitric oxide-donating drugs targeting the therapeutic areas of inflammation and cardiometabolic disease, announced the initiation of the third pivotal phase III clinical trial for naproxcinod in patients with osteoarthritis (OA) of the hip.

Wednesday Jul 11, 2007
Genzyme's Pivotal Trial of Hylastan for OA of the Knee Fails to Achieve Primary Endpoint
Genzyme Corp announced unfavorable topline results from a pivotal study investigating the safety and efficacy of hylastan, a viscosupplementation product, in treating pain in patients with osteoarthritis (OA) of the knee...

Wednesday Jul 11, 2007
Corin's Hip Resurfacing System Gains US FDA Approval; Stryker to Market in the US in Third Quarter of 2007
Stryker Corp, one of the world's leading medical technology companies with a broad range of products in orthopaedics, announced that it will begin marketing the Corin Group PLC's CormetTM Hip Resurfacing System by  the third quarter of 2007...

Friday Jul 06, 2007
Chi-Med Announces Positive Phase II Data for Botanical Compound, HMPL-004, in Ulcerative Colitis

Chi-Med, the Hutchison Whampoa-backed pharmaceutical and healthcare group, announced positive results for its phase II proof-of-concept study for HMPL-004 in mild-to-moderate ulcerative colitis (UC).

Thursday Jun 28, 2007
FDA Approves New Labeling for Carticel® in Repair of Articular Knee Cartilage
Genzyme Corporation announced that the US FDA has approved new labeling for Carticel® based on the company's completing a final FDA postapproval commitment study...

Monday Jun 25, 2007
Pfizer's Lyrica^R Receives FDA Approval for Fibromyalgia in Adults

Pfizer Inc announced that the US FDA approved Lyrica® (pregabalin) capsules CV for the management of fibromyalgia, one of the most common chronic, widespread pain conditions in the US...

Thursday Jun 21, 2007
Genzyme Files for FDA Approval of Single-Treatment Synvisc-Oneâ„¢ for OA Knee Pain
Genzyme Corp announced filing with the US FDA for product marketing authorization (PMA) of Synvisc-Oneâ„¢, the single treatment combining three doses of Synvisc® (hylan G-F 20) that provides up to 6 months of pain relief from osteoarthritis (OA) of the knee...

Monday Jun 11, 2007
Centocor's Remicade® (Infliximab) Receives EU Approval as First and Only Biologic for the Treatment of Pediatric Patients With Severe, Active Crohn's Disease
Centocor, Inc, a wholly owned subsidiary of Johnson & Johnson and Schering-Plough Corp, announced that the European Commission has approved a new indication for Remicade (infliximab) allowing for the treatment of severe, active Crohn's disease (CD) in pediatric patients ages 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator, and primary nutrition therapy, or who are intolerant to, or have contraindications for such therapies...

Monday Jun 11, 2007
Abbott's HUMIRA® (Adalimumab) Approved in the European Union for the Treatment of Crohn's Disease
Abbott Laboratories announced that it has received marketing authorization from the European Commission for the use of Humira® (adalimumab) as a treatment for severe Crohn's disease (CD)...

Friday Jun 01, 2007
HGS and GSK Initiate Second Phase III Clinical Trial of LymphoStat-B^R (Belimumab) in Lupus
Human Genome Sciences, Inc. announced that dosing has begun in BLISS-52, the second of two pivotal phase III clinical trials of LymphoStat-B® (belimumab), a human monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS®), in patients with active systemic lupus erythematosus (SLE).

Wednesday May 23, 2007
4SC AG Updates Progress of Phase IIa Clinical Trial in RA

4SC AG, focusing on the discovery and development of novel drug candidates for inflammatory diseases and cancer using a cheminformatics-based technology platform, reported on the progress of a phase IIa clinical trial of its lead drug candidate SC12267, an orally bioavailable small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), for the treatment of rheumatoid arthritis (RA)...

Wednesday May 16, 2007
AlphaRx and Proprius Report Nonachievement of Primary Endpoints in Their Topical NSAID (Indaflexâ„¢) Phase II Study in Osteoarthritis
AlphaRx Inc (MARKHAM, an emerging drug delivery company, and Proprius Pharmaceuticals, a specialty pharmaceutical and diagnostic services company that focuses on the area of rheumatology and autoimmune diseases, announced that results from the Indaflexâ„¢ 2.5% Topical Indomethacin Cream exploratory phase II clinical trial for osteoarthritis (OA) of the knee (INDF-200) did not achieve its primary endpoints....

Wednesday May 09, 2007
Abbott's ABT-874 Shows Positive Results in Phase II Psoriasis Study
 
Abbott Laboratories announced positive results from a 12-week, double-blind, placebo-controlled phase II study in which its investigational treatment, ABT-874, a fully human monoclonal antibody designed to target and neutralize interleukin-12 and interleukin-23, significantly reduced psoriasis symptoms in the majority of patients treated...

Monday May 07, 2007
Novartis' Once-Yearly Reclast^R Significantly Reduces Bone Fractures in Women With Postmenopausal Osteoporosis
Novartis Pharmaceuticals Corp announced that its once-yearly treatment of Reclast^R (zoledronic acid) significantly reduces the incidence of all types of osteoporotic bone fractures in women with postmenopausal osteoporosis...

Thursday May 03, 2007
FDA Approves Labeling Update for Orencia® (Abatacept) to "Inhibiting" Structural Joint Damage in Adults with Moderate-to-Severe RA
Bristol-Myers Squibb Company announced that the US FDA has approved an update to the product labeling for Orencia® (abatacept) regarding the progression of structural joint damage in rheumatoid arthritis (RA) patients...

Friday Apr 27, 2007
Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
Wyeth Pharmaceuticals, a division of Wyeth, announced that the US FDA has issued an approvable letter for bazedoxifene (ViviantTM), a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis...

Monday Apr 23, 2007
Rigel Provides Clinical Update of R788 Phase II Trials in ITP and RA

Rigel Pharmaceuticals, Inc, a clinical-stage drug development company, provided an update on R788, currently involved in ongoing phase II clinical trials in immune thrombocytopenic purpura (ITP) and rheumatoid arthritis (RA)...

Tuesday Apr 17, 2007
Neurochem's Eprodisate (Kiactaâ„¢) for AA Amyloidosis Approval Decision Delayed 3 Months by US FDA
Neurochem (International) Limited announced that it received notification from the US FDA that the action date for FDA's review of the New Drug Application (NDA) for eprodisate (Kiactaâ„¢, 1,3-propanedisulfonate, formerly Fibrillexâ„¢) an oral investigational product candidate for the treatment of amyloid A (AA) amyloidosis, has been extended to July 16, 2007...

Tuesday Apr 17, 2007
Is the "Golden Moment of Opportunity" to Improve FDA's Drug Safety Work About to Be Wasted?
The FDA's proposals for the reauthorization of the Prescription Drug User Fee Act are weighed and found wanting by experts in three New England Journal of Medicine commentaries...

Monday Apr 16, 2007
Abbott Seeks US and EU Regulatory Approval for HUMIRA® (Adalimumab) in Psoriasis; Receives US FDA Approval in Crohn's Disease
Abbott Laboratories announced that it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the US FDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for moderate-to-severe chronic plaque psoriasis, the fifth autoimmune disease targeted for HUMIRA therapy in both the US and Europe...

Friday Apr 13, 2007
FDA Panel Rejects Merck's Arcoxia By 20-to-1 Vote
Citing increased cardiovascular risks, an FDA advisory panel voted 20-to-1 against recommending approval of the COX-2 inhibitor ArcoxiaR (etoricoxib) for the treatment of osteoarthritis...

Thursday Apr 05, 2007
More Evidence Points Toward Safety of Anti-TNF Drugs During Pregnancy
Three recent case reports add to an accumulating body of evidence that the TNF-blockers are safe during pregnancy, but one new report is far from the final word on the issue...

Monday Apr 02, 2007
News Analysis: New FDA Conflict-of-Interest Guidelines May Impact Advisory Committees
FDA is moving to tighten financial conflict-of-interest guidelines for members of FDA advisory committees, despite evidence that excluding participants with such interests would have had no impact on the vote outcomes of prior meetings…

Monday Apr 02, 2007
Nuvo Provides Update on Pennsaid® Discussions with the US FDA

Nuvo Research Inc is a publicly traded pharmaceutical company that focuses on developing innovative site-specific therapeutics that are delivered topically using the company's skin-penetrating technologies...

Wednesday Mar 21, 2007
BioMimetic Receives Orphan Drug Designation for rhPDGF-BB Treatment of Osteonecrosis of the Jaw
BioMimetic Therapeutics, Inc, an emerging leader in developing and commercializing bioactive drug-device combination drugs to heal musculoskeletal injuries and disease, including periodontal, orthopaedic, spine and sports injuries, announced that it has received orphan drug designation from the US FDA for its protein therapeutic, recombinant human platelet-derived growth factor (rhPDGF-BB)...

Tuesday Mar 20, 2007
POZEN Reports Positive Outcome for "Safer Aspirin" PA 325 Proof-of-Concept Study
POZEN Inc, a pharmaceutical company developing products for the treatment of acute and chronic pain, announced positive results of its "Safer Aspirin" PA 325 proof-of-concept study conducted during the fourth quarter of 2006...

Thursday Mar 15, 2007
Unigene Receives $5.5 Million Milestone Payment for Calcitonin Collaboration in Initiation of Osteoporosis Phase III Clinical Trial

Unigene Laboratories, Inc, a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs, announced that the initiation of a phase III clinical study conducted by Nordic Bioscience, the development partner with Novartis Pharmaceuticals AG, to treat osteoporosis with oral calcitonin has triggered a $5.5 million milestone payment due from Novartis to Unigene...
 

Thursday Mar 15, 2007
Cytochroma Completes Enrollment in Phase II Psoriasis Clinical Trial for CTA018, a Novel Vitamin D Analog
Cytochroma Inc, a privately-held, integrated specialty pharmaceutical company engaged in the development and commercialization of proprietary products related to vitamin D deficiency and novel vitamin D therapies to treat hyperproliferative disorders such as psoriasis and cancer, announced that it has completed the enrollment of patients in a phase II randomized, double-blind, placebo-controlled clinical trial of CTA018, a cream base for chronic plaque psoriasis.

Monday Mar 12, 2007
Novartis, Nordic Bioscience to Initiate Osteoporosis Phase III Program Using Emisphere's Eligen^R Technology for Oral Salmon Calcitonin

Emisphere Technologies, Inc, a biopharmaceutical company pioneering the oral delivery of otherwise injectable drugs, announces that Novartis Pharmaceutical AG and its development partner Nordic Bioscience A/S will initiate a phase III clinical trial for the treatment of osteoporosis with an oral form of salmon calcitonin (SMC021), a new drug candidate, using Emisphere's eligen® delivery technology...

Friday Mar 09, 2007
La Jolla Pharmaceutical Reports Positive Interim Antibody Results From Riquent® Lupus Phase III Trial; Results Imply Greater Probability of Clinical Benefit in the Treatment of Lupus Renal Disease as a Trial Outcome
La Jolla Pharmaceutical Company, a clinical-stage pharmaceutical company focused on autoimmune and inflammatory disorders, announced positive interim antibody results from its ongoing double-blind, placebo-controlled randomized phase III trial of Riquent® (abetimus sodium), its drug candidate for the treatment of renal disease in patients with systemic lupus erythematosus (SLE).

Monday Mar 05, 2007
La Jolla Pharmaceutical Company Implements Several Modifications and Updates Status of  Phase III Riquent® Study for the Treatment of Lupus Renal Disease
La Jolla Pharmaceutical Company (SAN DIEGO, California) announced its continued progress in enrolling patients in its phase III clinical trial of Riquent® (abetimus sodium) for the treatment of lupus renal disease.

Wednesday Feb 28, 2007
Abbott's Humira^R (Adalimumab) Receives FDA Approval for Self-Administered Treatment of Moderate-to-Severe Crohn's Disease; Represents 4th FDA Approval in Immune-Mediated Diseases for Humira

Abbott announced it has received US FDA approval to market Humira® (adalimumab, a fully human anti-TNF-α monoclonal antibody) as a treatment for reducing the signs and symptoms and inducing and maintaining clinical remission of moderately-to-severely active Crohn's disease (CD) in adults who have had an inadequate response to conventional therapy...

Tuesday Feb 27, 2007
UCB Reports Significant Reduction in Joint Damage From Phase III Results With Cimzia in Rheumatoid Arthritis; Fc Region Present in Conventional Anti-TNFs Is Not Required for Activity
UCB, a global biopharmaceutical company, announced results of an international, multicenter, placebo-controlled phase III study (RAPID 1) involving nearly 1000 patients that evaluated the investigational agent Cimziaâ„¢ (certolizumab pegol)...

Thursday Feb 22, 2007
Zimmer and ISTO Start Clinical Trial of Neocartilage (DeNovo® ET Engineered Tissue Graft), a Novel Cartilage Regeneration Treatment 
Zimmer Holdings, Inc, an orthopaedic leader in reconstructive and spinal implants, trauma, and related orthopaedic surgical products, and ISTO Technologies, Inc, a clinical-stage orthobiologic company that focuses on cell-based technology for the repair and regeneration of damaged cartilage in joints and spinal discs, announced the initiation of a clinical trial for Neocartilage, a living tissue-engineered graft...

Thursday Feb 15, 2007
HGS and GSK Initiate Phase III Clinical Trial of LymphoStat-B® in Lupus
Human Genome Sciences, Inc and GlaxoSmithKline PLC announced the initiation of dosing in BLISS-76, one of two pivotal phase III clinical trials of LymphoStat-B® (belimumab, a human monoclonal antibody that blocks the biological activity of B-lymphocyte stimulator, or BLyS®) in patients with active systemic lupus erythematosus (SLE)...

Tuesday Feb 13, 2007
SRI and Telik Announce Exclusive License for SRI to Develop MCP-1 Antagonist for Autoimmune and Inflammatory Diseases
Telik, Inc, a biopharmaceutical company dedicated to discovering, developing, and commercializing novel small molecule drug candidates, and SRI International, an independent nonprofit research and development organization, announced that they have signed an exclusive license agreement...

Monday Jan 22, 2007
Shire's LIALDA (mesalamine) Approved by the US FDA for Active Mild-to-Moderate Ulcerative Colitis; the First Oral Once-Daily Mesalamine
Shire plc  announced that the US FDA has approved Lialda (5-aminosalicyclic acid (5-ASA), mesalamine) with MMX technology, for the induction of remission in patients with active, mild-to-moderate ulcerative colitis (UC).

Tuesday Jan 16, 2007
Horizon Therapeutics' Phase III Trial of GI-Friendly NSAID for Mild-to-Moderate Pain Relief, Including Patients With Osteoarthritis, to be Conducted Under a Special Protocol Assessment; Company Raises $15 Million in Series B Financing
Horizon Therapeutics, Inc, a privately-held, late-stage biopharmaceutical company is focusing on the development and commercialization of therapeutic treatments for mild-to-moderate pain management based on innovative combinations of approved pharmaceutical products that seek to improve safety, efficacy, and patient compliance.

Tuesday Jan 16, 2007
FDA Sets New Rule on Calcium/Vitamin D Osteoporosis Claims for Food, Diet Supplement Labeling
The FDA will permit a new "calcium plus vitamin D" claim in food and dietary supplement labeling for reducing the risk of osteoporosis and will shorten the required label in the hope that more dairy, juice, and other products that qualify will put it on their packaging, thus increasing consumer awareness...

Wednesday Jan 10, 2007
Osiris Receives US FDA Fast Track Status for Prochymalâ„¢ Stem Cell Therapy and Clearance to Start Phase III Clinical Trial in Treatment-Resistant Crohn's Disease
Osiris Therapeutics, a leader in adult stem cell therapy, announced that Prochymalâ„¢, a preparation of mesenchymal stem cells obtained from the bone marrow of healthy adult donors and specially formulated for intravenous infusion, has received fast-track designation from the US FDA, expediting the development of the stem cell treatment for Crohn's disease that does not respond to standard therapies.

Wednesday Jan 03, 2007
Shire Receives Label Agreement in Europe for Ulcerative Colitis Treatment, Mezavant (mesalazine)
Shire plc, the third largest pharmaceutical company in the UK, announced that core labeling information, part of Shire's Marketing Authorization Application for the ulcerative colitis (UC) treatment Mezavantâ„¢ (mesalazine, once-daily, high-dose 5-aminosalicylic acid (5-ASA) in a delayed and extended release formulation), has been agreed by the regulatory agencies for the 15 European countries (including Germany, France, Spain, and the United Kingdom) participating in the decentralized procedure.

Wednesday Jan 03, 2007
Nuvo Receives Approvable Letter from US FDA for Pennsaid, a Topical Nonsteroidal Anti-Inflammatory for the Treatment of Osteoarthritis of the Knee; Nuvo Licenses Canadian Pennsaid Plus Rights to Squire Pharmaceuticals, a Subsidiary of Paladin Labs
Nuvo Research Inc announced that it has received an approvable letter from the US FDA for Pennsaid® (1.5% w/w diclofenac sodium solution), a topical nonsteroidal anti-inflammatory (NSAID) for the treatment of osteoarthritis (OA) of the knee.

Thursday Dec 21, 2006
ZymoGenetics and Serono Begin Phase II Clinical Trial with Atacicept (TACI-Ig) in RA
ZymoGenetics, Inc and Serono announced the start of a phase II clinical trial of their investigational therapeutic atacicept (formerly TACI-Ig) in patients with rheumatoid arthritis (RA). The randomized, double-blind, placebo-controlled, multicenter, dose-finding study will investigate the efficacy of atacicept in patients with an inadequate disease response to prior treatment with TNF inhibitors.

Tuesday Dec 19, 2006
FDA Warns of Fatal PML Risk With Rituximab Treatment
FDA reports deaths of two lupus patients treated with rituximab, warns of PML risk...

Tuesday Dec 19, 2006
FDA Approves Celebrex for JRA
The US Food and Drug Administration has approved celecoxib (Celebrex) for treatment of juvenile rheumatoid arthritis...

Tuesday Dec 05, 2006
Nastech, P&G Amend Agreement for Development of Parathyroid Hormone (PTH1-34) Nasal Spray for Treatment of Osteoporosis
Nastech Pharmaceutical Company Inc (BOTHELL, Washington) announced the amendment of its previous agreement with Procter & Gamble Pharmaceuticals, Inc (P&G) for the clinical development program of the parathyroid hormone (PTH1-34) nasal spray for the treatment of osteoporosis. The amendment includes an additional phase II dose ranging study as well as a change in the timing of payments.

Friday Dec 01, 2006
Registry Study Says RA Biologics Raise Odds of Melanomas and Skin Cancers, Not Other Malignancies

The latest attempt to sort out the relationship between TNF inhibitors and cancer risk in RA patients found no increase in overall cancer risk, but substantial increases in melanoma and nonmelanomatous skin cancer rates in patients treated with these agents...Wolfe F, et al. Presented at: ACR 2006 Meeting.

Thursday Nov 30, 2006
FDA Panel Gives Nod to Celebrex for JRA
Despite a desire for more long term safety data, an advisory committee of the US Food and Drug Administration voted 15-1 Wednesday to recommend approval of celecoxib (CelebrexR) for the treatment of juvenile rheumatoid arthritis (JRA)...

Tuesday Nov 21, 2006
Bioenvision Files to Start Phase I Trials in Germany of Clofarabine Gel for Psoriasis
Bioenvision, Inc, a company focused on the development and marketing of compounds and technologies for the treatment of cancer, announced the filing of a clinical trial authorization (CTA) to begin two phase I studies in Germany of clofarabine gel for the treatment of psoriasis.

Monday Nov 20, 2006
Pregabalin Offers Durable Pain Relief in Fibromyalgia
The anticonvulsant pregabalin may offer extended pain relief to fibromyalgia patients... Crofford LJ, et al. Presented at: ACR 2006 Meeting.

Thursday Nov 16, 2006
Immunomedic, UCB Phase III Trial of Epratuzumab in Lupus Patients No Longer on Clinical Hold
Immunomedics, Inc (MORRIS Plains, New Jersey), a biopharmaceutical company focused on developing therapeutic monoclonal antibodies, announced that their partner, UCB, SA (BRUSSELS, Belgium) has received notification from the US FDA that the clinical hold on existing trials with epratuzumab (a humanized IgG1 monoclonal antibody targeting the B-cell specific surface antigen CD22) in patients with systemic lupus erythematosus (SLE) has been lifted.

Wednesday Nov 15, 2006
FDA's Woodcock Pushes for Biomarkers as Key to New Drug Development and Improving Drug Safety
Janet Woodcock, MD, the FDA's deputy chief for operations, speaking at the American College of Rheumatology meeting, said that the 1990s era of blockbuster drugs is over, and that a fast public/private collaboration to identify biomarkers that permit drug researchers to "move beyond demographics" is needed to get new drug development moving and to improve drug safety... ACR 2006 Meeting.

Monday Nov 06, 2006
Array BioPharma Reports Success in Two Approaches to Inflammatory Disease: MEK Inhibitor Achieves Phase I Clinical Objectives; p38 MAP Kinase Inhibitor Advances into Clinical Development
Array BioPharma Inc. (BOULDER, Colorado), a biopharmaceutical company focused on the discovery, development, and commercialization of orally active, small molecule drugs for the treatment of inflammatory diseases and cancer, announced preliminary results from a phase I clinical trial evaluating its first-in-class MEK (MAPK kinase) inhibitor for the treatment of inflammatory diseases.

Wednesday Nov 01, 2006
Regeneron's Phase III Clincial Program for Interleukin-1 (IL-1) Trap, a Long Lasting IL-1 Inhibitor, Achieves Primary Endpoints in Studies with Patients Diagnosed with CAPS, a Spectrum of Rare Chronic Autoinflammatory Syndromes
Regeneron Pharmaceuticals, Inc, announced positive data from a phase III clinical program designed to provide two separate demonstrations of efficacy for the investigational drug Interleukin-1 (IL-1) Trap within a single group of patients suffering from CAPS (CIAS1-related Autoinflammatory Periodic Syndromes).

Monday Oct 30, 2006
Neurochem Submits Complete Response to US FDA Approvable Letter for Eprodisate (KIACTAâ„¢) for the Treatment of Amyloid A Amyloidosis
Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc, headquartered in Québec, Canada, announced that it has submitted a complete response to the US FDA approvable letter for eprodisate (1,3-propanedisulfonate, Kiacta™, formerly Fibrillex™), an oral investigational product candidate for the treatment of amyloid A (AA) amyloidosis.
 

Monday Oct 30, 2006
IOM Study Slams FDA, Proposes Top-Down Restructuring and Much More Funding
The Institute of Medicine report on the US Food and Drug Administration's problems ensuring drug safety finds major flaws in nearly every aspect of the agency's functioning. The IOM proposes a massive restructuring that would greatly extend FDA's authority and enforcement powers and would dramatically change how new drugs are approved and marketed in the US.

Monday Oct 23, 2006
Osiris Reports Positive Initial Results from Pilot Phase II Study of its Prochymalâ„¢ Stem Cell Therapy in Treatment-Resistant Crohn's Disease
Osiris Therapeutics, a leader in adult stem cell therapy, announced positive results from a pilot 10-patient phase II study using Prochymalâ„¢, an intravenous formulation of mesenchymal stem cells obtained from the bone marrow of healthy volunteer donors, for the treatment of patients with moderate to severe Crohn's disease (CD) who had failed to respond to standard treatments, such as steroids and infliximab (RemicadeR, Centocor, Inc).

Monday Oct 23, 2006
Centocor's Remicade® Receives Expanded Indication From US FDA for Ulcerative Colitis: Maintains Clinical Remission and Mucosal Healing
Centocor, Inc, a wholly owned subsidiary of Johnson & Johnson, announced that the US FDA has approved RemicadeR (infliximab) for maintaining clinical remission and mucosal healing in patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Monday Oct 16, 2006
Potassium Citrate Supplements Increase Bone Mass
Potassium citrate supplements might help postmenopausal women with osteopenia increase their bone mineral density (BMD)... Jehle S, et al. J Am Soc Nephrol. 2006;17:3213–3222.

Thursday Oct 12, 2006
Aspreva Achieves Targeted Patient Enrollment in Phase III Clinical Trial for CellCept In Lupus Nephritis
Aspreva Pharmaceuticals Corporation, an emerging pharmaceutical company focused on identifying, developing, and commercializing new indications for approved drugs and late-stage drug candidates for patients living with less common diseases, announced the completion of the targeted enrollment of 358 patients in its global 117-site phase III clinical trial for CellCept® (mycophenolate mofetil, F. Hoffmann-La Roche) in the treatment of lupus nephritis...

Thursday Oct 12, 2006
CardioVascular BioTherapeutics, Tufts Initiate hFGF-1 R&D for Osteoporosis

CardioVascular BioTherapeutics, Inc. announced that it has signed a sponsored research agreement with Tufts University School of Medicine to study the potential use of human acidic fibroblast growth factor-1 (hFGF-1), the active component of the Company's Cardio Vascu-Growâ„¢, to treat patients with osteoporosis...

Monday Oct 02, 2006
La Jolla Pharmaceutical to Expand Number of Clinical Trial Sites for Its Phase III International Trial of Riquent for the Treatment of Lupus Renal Disease
La Jolla Pharmaceutical Company (SAN DIEGO, Calif.), a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation, announced  progress and the expansion of its phase III trial of Riquent® (abetimus sodium, previously referred to as LJP 394) for the treatment of lupus renal disease, a leading cause of sickness and death in patients with lupus.

Thursday Sep 28, 2006
Centocor's Remicade Approved by US FDA for Treatment of Chronic Severe Plaque Psoriasis
Centocor, Inc. (HORSHAM, Pa.), a wholly owned subsidiary of Johnson & Johnson, announced that the US FDA has approved Remicade^R (infliximab) for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and for whom other systemic therapies are medically less appropriate.

Wednesday Sep 27, 2006
UCB, Immunomedic Phase III of Epratuzumab in Patients With Systemic Lupus Erythematosus on Clinical Hold
UCB, SA, licensing partner of Immunomedics, Inc. (Morris Plains, NJ), announced that it has voluntarily, temporarily suspended dosing in the phase III clinical studies of epratuzumab (humanized anti-CD22 antibody) in patients with systemic lupus erythematosus (SLE) because of end-stage manufacturing observations by UCB during a recent routine quality assurance audit of the Immunomedics facilities.

Monday Sep 25, 2006
Rituximab Quickly Reduces Disease Activity in Treatment-Resistant RA
Rituximab added to methotrexate significantly reduces disease activity in patients whose RA is resistant to TNF inhibitors... Cohen SB, et al. Arthritis Rheum. 2006;54:2793-2806.

Monday Sep 18, 2006
Novartis' Once-Yearly Reclast Investigational Infusion Osteoporosis Treatment Significantly Cuts Risk of Spine and Hip Fractures in Postmenopausal Women
Novartis Pharmaceuticals Corporation announced that phase III data presented at the 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), September 15–19, 2006, in Philadelphia, Pa, demonstrated that its investigational, once-yearly bisphosphonate 15-minute infusion treatment, Reclast® (zoledronic acid) 5 mg, was highly effective at reducing the incidence of bone fracture in women with postmenopausal osteoporosis across the most common fracture sites—hip, spine, and nonspine (with the exception of face, fingers, and toes)—with sustained effect over 3 years.

Tuesday Sep 12, 2006
Safety Studies Clear Most Coxibs of Class Effect, Raise Questions About Diclofenac
Two new analyses published early online today by JAMA because of their public health implications show kidney and heart problems associated with rofecoxib (even after brief use) but not with other COX-2 inhibitors, and raise new questions about the safety of diclofenac...

Monday Sep 11, 2006
Abbott Seeks US and EU Approvals for HUMIRA (Adalimumab) for Crohn's Disease
Abbott announced it has simultaneously submitted a supplemental Biologics License Application with the US FDA and a Type II Variation to the European Medicines Agency seeking approval to market HUMIRA^R (adalimumab) as a treatment for moderate-to-severe Crohn's disease...

Thursday Aug 24, 2006
Merck's Investigational Selective COX-2 Inhibitor, ARCOXIA (Etoricoxib), for Arthritis and Pain Yields Mixed Clinical Results Against the NSAID Diclofenac
Merck & Co, Inc. announced preliminary analyses of the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) program study as showing the rate of confirmed thrombotic cardiovascular (CV) events to be similar between the selective COX-2 inhibitor ARCOXIAâ„¢ (the planned successor to Vioxx) and diclofenac, the most widely prescribed traditional nonsteroidal anti-inflammatory drug (NSAID).

Tuesday Aug 22, 2006
Comarketers Procter & Gamble and sanofi-aventis Gain FDA Approval of Actonel for Broader Use in Men With Osteoporosis
Procter & Gamble and sanofi-aventis announced that the US FDA approved Actonel^R (risedronate sodium tablets) 35 mg for treatment to increase bone mass in men with osteoporosis.

Monday Aug 21, 2006
Osiris IPO Raises $38.5 Million to Advance Mesenchymal Stem Cell Therapies
Osiris Therapeutics, Inc. announced that underwriters sold 3.5 million shares of its common stock at a price of $11.00 per share, achieving the lower end of the targeted share price for its initial public offering and raising $38.5 million.

Friday Aug 18, 2006
Neurochem Receives Approvable Letter from US FDA for Eprodisate (Kiactaâ„¢) for the Treatment of Amyloid A Amyloidosis
Neurochem, Inc. announced that it has received an Approvable Letter from the US FDA for eprodisate (1,3-propanedisulfonate, Kiactaâ„¢, formerly Fibrillexâ„¢), an oral investigational product candidate for the treatment of Amyloid A (AA) amyloidosis.

Tuesday Aug 15, 2006
Centocor's REMICADE Receives Expanded Psoriatic Arthritis Indication
Centocor, Inc. announced that the US FDA has expanded marketing approval for Remicade® (infliximab) to inhibiting the progression of structural damage and improving physical function in patients with active psoriatic arthritis (PsA), in addition to reducing the signs and symptoms of active arthritis. 

Thursday Aug 10, 2006
HGS to Initiate Phase III Trials of LymphoStat-B in Lupus; to Receive $24 Million from GSK
Human Genome Sciences, Inc. announced its phase III clinical development plans for LymphoStat-Bâ„¢ (belimumab, a human monoclonal antibody that specifically inhibits the biological activity of B-lymphocyte stimulator [BLyS], a protein required for the development of B-lymphocyte cells into mature plasma B cells) in patients with active systemic lupus erythematosus (SLE).

Thursday Aug 10, 2006
La Jolla Pharmaceutical Reactivates Enrollment in Phase III Study of Riquent in Lupus; Patients to Receive Higher Doses Than in Previous Studies
La Jolla Pharmaceutical Company announced that it has reactivated enrollment in its phase III 12-month treatment trial of RiquentR (abetimus sodium) for the treatment of lupus renal disease.

Tuesday Aug 01, 2006
Schering-Plough's REMICADE Receives EU Approval as Monotherapy for Treatment of Psoriatic Arthritis; Abbott's HUMIRA Receives FDA Approval for Treatment of Ankylosing Spondylitis
Schering-Plough Corporation announced that the European Commission approved the use of REMICADE® (infliximab) as monotherapy in the treatment of active and progressive psoriatic arthritis (PsA) in patients who show intolerance to methotrexate (MTX) or for whom MTX is contraindicated.

Friday Jul 28, 2006
Serono Initiates First Large-Scale European Pharmaco-Epidemiologic Study to Gather Additional Safety Data on RaptivaR in Psoriasis
Serono announced that it has initiated a prospective 7-year cohort, multi-national, multicenter study in more than 7000 adult patients with moderate-to-severe plaque psoriasis who have been treated with RaptivaR (efalizumab).

Thursday Jul 27, 2006
FDA Approves 13 Generic Versions of Mobic
FDA approves 13 meloxicam formulations for the treatment of osteoarthritis

Wednesday Jul 26, 2006
GAO, HHS Inspector General Push FDA to Tighten Up on Postmarketing Studies
A report from the Department of Health and Human Services Inspector General adds to growing pressure for the US Food and Drug Administration to hold pharma companies accountable for the burgeoning number of promised—but never completed—postmarketing studies.

Tuesday Jul 25, 2006
Nuvo's Pennsaid® NDA Resubmission for the Treatment of Osteoporosis Accepted for Review by US FDA
Nuvo Research Inc announced that it has resubmitted its New Drug Application (NDA) for Pennsaid® (1.5% w/w diclofenac sodium solution), a topical nonsteroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis (OA) of the knee to the US FDA.

Friday Jul 21, 2006
UCB's CIMZIATM Achieves PASI 75 at Week 12 of 83% in Phase II for Psoriasis
UCB announced positive results from the first phase II clinical trial of CIMZIATM (certolizumab pegol, CDP870), the first and only PEGylated Fab' fragment of a humanized anti-TNF-α antibody, in the treatment of patients with moderate-to-severe chronic plaque psoriasis.

Tuesday Jun 27, 2006
Wyeth Submits NDA to FDA for Bazedoxifene, an Osteoporosis Drug Candidate; Ligand Pharmaceuticals Earns Milestone Payment
Wyeth Pharmaceuticals (MADISON, N.J.) and Ligand Pharmaceuticals Incorporated (SAN DIEGO, Calif.) separately announced that Wyeth has submitted a New Drug Application (NDA) to the US FDA for the approval of bazedoxifene, a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis.

Tuesday Jun 27, 2006
Abbott Receives FDA Approval for New HUMIRA® Injection Device
Abbott Laboratories announced that the US FDA approved the HUMIRA® Pen, a new single-use, disposable, pen-like device for administering HUMIRA, a treatment approved in the US for moderate-to-severe rheumatoid arthritis and for active psoriatic arthritis....

Tuesday Jun 20, 2006
Nastech Receives $7 Million Milestone Payment From P&G; Will Make and Supply to P&G PTH1-34 Nasal Spray for Osteoporosis
Nastech Pharmaceutical Company Inc, of Bothell, Washington, announced the receipt of a $7 million payment for attaining a development milestone under its development and commercialization agreement with Procter & Gamble Pharmaceuticals, Inc, pertaining to parathyroid hormone (PTH1-34) nasal spray for the treatment of osteoporosis...

Monday Jun 12, 2006
Regeneron's IL-1 Trap Receives Fast-Track Designation From US FDA for CIAS1-Associated Periodic Syndromes (CAPS)
Regeneron's IL-1 Trap has received fast-track designation from the US FDA for CIAS1-Associated Periodic Syndromes (CAPS), a family of rare autoinflammatory diseases...

Saturday Jun 10, 2006
Regeneron's IL-1 Trap Receives Fast-Track Designation from US FDA for CIAS1-Associated Periodic Syndromes (CAPS), a family of rare autoinflammatory diseases

Regeneron's IL-1 Trap Receives Fast-Track Designation from US FDA for CIAS1-Associated Periodic Syndromes (CAPS), a family of rare autoinflammatory diseases

Friday Jun 09, 2006
Aspreva and Roche Granted Orphan Drug Designation for Mycophenolate Mofetil (Cellcept®) in Pemphigus Vulgaris
Aspreva Pharmaceuticals Corp announced that the US FDA has granted Orphan Drug designation for mycophenolate mofetil...

Monday Jun 05, 2006
New Treatment for Lupus Brought to (UVA-1) Light
Sunlight can trigger exacerbations of systemic lupus erythematosus, but the long-wave ultraviolet A-1 light can normalize some immune function in lupus patients, and should be considered for therapeutic use... Pavel S. Rheumatology. 2006;45:653-655.

Wednesday May 24, 2006
ImmuPharma's IPP-201101 Lupus Drug Completes Phase I, Moves into Phase II Trial
ImmuPharma, based in London, UK, announced the successful completion of a placebo-controlled phase I clinical study of its new treatment for systemic lupus erythematosus...

Wednesday May 24, 2006
Centocor's Remicade^R Approved by US FDA for Pediatric Crohn's Disease
Centocor Inc announced US FDA approval of Remicade® (infliximab) for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease...

Wednesday May 17, 2006
Immunomedics and UCB Announce Collaboration and License Agreement for Epratuzumab for Autoimmune Diseases
Immunomedics, Inc, and UCB announced a development collaboration and license agreement for Immunomedics' lead product, epratuzumab...

Monday May 08, 2006
Additional Neuropathies Linked to TNF Inhibitors

Guillain-Barré syndrome, demyelinating and axonal neuropathies, and a central nervous system syndrome have been reported recently in patients treated with TNF inhibitors... Shin I-SJ, et al. Arthritis Rheum. 2006;54:1429-1434; Jarand J, et al. J Rheumatol. 2006;33:1018-1020.

Thursday May 04, 2006
CV Risk With Vioxx Rises in First 60 Days
Rofecoxib (Vioxx) increases the risk of cardiovascular events, typically within the first 60 days of use, while naproxen reduces such risk, and other coxibs and nonselective NSAIDs have no effect... Solomon DH, et al. Arthritis Rheum. 2006;54:1378-1389.

Thursday May 04, 2006
Adding Alefacept Increases MTX Response in Psoriatic Arthritis
Alefacept plus methotrexate significantly increased response rates in patients with psoriatic arthritis... Mease PJ, et al. Arthritis Rheum. 2006;54:1638-1645.

Friday Apr 28, 2006
Labopharm's Phase III Study for Once-Daily Tramadol Achieves Primary Endpoint in Patients With OA of the Knee
Labopharm Inc, of Laval, Quebec, Canada, announced that the phase III clinical trial for its once-daily formulation of the analgesic tramadol in patients with osteoarthritis (OA) of the knee achieved statistical significance for the primary endpoint...

Wednesday Apr 26, 2006
Neurochem's Eprodisate (Fibrillexâ„¢) Granted Priority Review by US FDA for the Treatment of Amyloid A Amyloidosis
Neurochem International Ltd, of Lausanne, Switzerland, announced that its new drug application for eprodisate (1,3-propanedisulfonate, Fibrillexâ„¢) for the treatment of Amyloid A amyloidosis has been granted priority review by the FDA...

Wednesday Apr 26, 2006
Neurochem's Eprodisate (Fibrillexâ„¢) Granted Priority Review by US FDA for the Treatment of Amyloid A Amyloidosis
Neurochem (International) Limited, of Lausanne, Switzerland, announced its new drug application (NDA) for eprodisate (1,3-propanedisulfonate, Fibrillexâ„¢) for the treatment of Amyloid A (AA) amyloidosis...

Wednesday Apr 26, 2006
Neurochem's Eprodisate (Fibrillexâ„¢) Granted Priority Review by US FDA for the Treatment of Amyloid A Amyloidosis
Neurochem (International) Limited, of Lausanne, Switzerland, announced its new drug application (NDA) for eprodisate (1,3-propanedisulfonate, Fibrillexâ„¢) for the treatment of Amyloid A (AA) amyloidosis...

Monday Apr 17, 2006
LEO Pharma and Warner Chilcott Launch Taclonex®, a Dual-Action, Once-Daily, Topical Therapy for Plaque Psoriasis in the US

Warner Chilcott, of Rockaway, NJ, and LEO Pharma A/S, of Copenhagen, Denmark, announced that Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) is now available for prescription in the US...

Friday Apr 14, 2006
Centocor's Remicade® Designated for Priority Review by FDA for Pediatric Crohn's Disease

Centocor, Inc, of Horsham, Pennsylvania, announced that the supplemental Biologics License Application (sBLA) for Remicade® (infliximab)...

Thursday Mar 30, 2006
Sodium Hyaluronate Effective in Chronic Shoulder Pain
Injections of sodium hyaluronate may be an effective and safe alternative to cyclooxygenase-2 inhibitors and other nonsteroidal anti-inflammatory drugs for the treatment of chronic shoulder pain... Blaine TA, et al. Presented at: 73rd Annual Meeting of the American Academy of Orthopaedic Surgeons; March 22–26, 2006; Chicago, Ill. Abstract 426.

Monday Mar 13, 2006
NPS Receives Approvable Letter From US FDA for Recombinant Human Parathyroid Hormone for Osteoporosis; FDA Expresses Concern Regarding Hypercalcemia
NPS Pharmaceuticals, Inc, of Salt Lake City, Utah, announced that it has received an "approvable letter" from the US Food and Drug Administration (FDA) for their new drug application for PREOS®...

Friday Mar 03, 2006
Rituximab Approved for Rheumatoid Arthritis Patients Refractory to TNF-Antagonists
The US Food and Drug Administration has approved the anti-CD20+ B-cell-targeted monoclonal antibody rituximab (Rituxan®) in combination with methotrexate for adult patients with moderate to severe rheumatoid arthritis who experienced an adequate response to one or more tumor necrosis factor antagonists...

Friday Feb 17, 2006
Neurochem Seeks FDA Marketing Approval for Fibrillexâ„¢ for the Treatment of Amyloid A Amyloidosis
Neurochem International Limited announced the submission to the US Food and Drug Administration (FDA) of the final modules of its rolling NDA for eprodisate...

Monday Feb 13, 2006
BioMimetic Therapeutics Files for IPO
BioMimetic Therapeutics, Inc, of Franklin, Tennessee, announced that it has filed a registration statement with the US Securities and Exchange Commission...

Wednesday Feb 08, 2006
Etanercept in Combination with Sulfasalazine, Hydroxychloroquine, or Gold Is Safe and Effective Treatment for RA
Etanercept in combination with sulphasalazine, hydroxychloroquine, or intramuscular gold is an effective and well-tolerated treatment for rheumatoid arthritis. O'Dell JR, et al. J Rheumatol. 2006;33:213-218.

Monday Jan 30, 2006
Can-Fite BioPharma Submits Clinical Protocol to FDA for Multinational Phase IIb Study of A₃ Adenosine Receptor Agonist for RA
Can-Fite BioPharma, of Petach Tikva, Israel, announced that it has submitted a draft protocol to the US Food and Drug Administration...

Wednesday Jan 18, 2006
FDA to Require Additional Positive Pivotal Trial for Genelabs' Lupus Drug Prestaraâ„¢
Genelabs Technologies, Inc, of Redwood City, California, announced that the US Food and Drug Administration will require an additional pivotal trial...

Wednesday Jan 11, 2006
Manhattan's PTH 1-34, a Topical Treatment for Psoriasis, Enters Phase IIa Trials
Manhattan Pharmaceuticals, Inc, of New York City, announced the initiation of a phase IIa clinical study of PTH 1-34, a parathyroid hormone-related peptide analog, for the topical treatment...

Wednesday Jan 11, 2006
Repligen and University of Michigan File Infringement Complaint Against BMS Over Orencia®
Repligen Corporation of Waltham, Massachusetts, announced that Repligen and the University of Michigan (UM) have filed a joint complaint against Bristol-Myers Squibb Corporation (BMS) for infringement of a US patent...

Wednesday Jan 04, 2006
Bristol-Myers Squibb Receives US Approval for Orencia® (Abatacept) for RA
Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has approved Orencia® (abatacept) for the treatment of rheumatoid arthritis (RA)

Wednesday Jan 04, 2006
Osiris Raises $19 Million in Private Equity Funding for Adult Stem-Cell Trials
Osiris Therapeutics, Inc, of Baltimore, Maryland, announced that it has closed a $19 million private equity round of financing in support of ongoing clinical trial programs employing its adult mesenchymal stem-cell technology...

Wednesday Dec 14, 2005
New England Journal of Medicine Editors Call for Correction of VIGOR Trial
In response to the revelation that three additional myocardial infarctions were withheld from the original Vioxx® GI Outcomes Research (VIGOR) trial submitted to the New England Journal of Medicine, the editors of the journal have called into question the integrity of the data and requested that the authors submit a correction to account for the "inaccuracies and deletions" in the original published article...Curfman GD, et al. N Engl J Med. 2005;353:2813-2814.

Tuesday Nov 29, 2005
Galderma Laboratories Receives FDA Approval for Clobex® Spray for Psoriasis
Galderma Laboratories of Fort Worth, Texas, announced that the US Food and Drug Administration has granted marketing approval for Clobex® ...

Tuesday Nov 29, 2005
Bio-Rad Granted FDA Clearance to Market Interpretive Software for Autoimmune Testing
Bio-Rad Laboratories, Inc, of Hercules, California, a manufacturer and distributor of life science research products and clinical diagnostics, announced...

Thursday Nov 17, 2005
Three Novel and Distinct Agents Show Promise in RA
Three promising new rheumatoid arthritis (RA) drugs—including an oral small-molecule inhibitor that targets a novel adenosine receptor (AR) and a new anti-tumor necrosis factor-alpha (TNF-α) agent—may soon augment the rheumatologist's ever-expanding armamentarium... Presented at: Annual Meeting of the American College of Rheumatology; November 12–17, 2005; San Diego, Calif.

Monday Nov 07, 2005
Positive Phase III Results for Remicade® in Pediatric Crohn's Disease Drives Fast Track Designation for Indication
Centocor, Inc (Horsham, Pa.), announced at the 18th Annual Meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition...

Tuesday Nov 01, 2005
US FDA Accepts sBLA and Grants Priority Review Status for Rituxan® for RA
Biogen Idec, Inc, of Cambridge, Massachusetts, and Genentech, Inc, of South San Francisco, California, announced that the US Food and Drug Administration (FDA) has granted priority status to the supplemental Biologics License Application (sBLA) for  Rituxan®...

Monday Oct 24, 2005
La Jolla Pharmaceutical Secures Funding to Commence Re-enrollment of Phase III Trial of Riquent® for Lupus Renal Disease
La Jolla Pharmaceutical Corporation of San Diego, California, announced that it has entered into an agreement...

Thursday Oct 06, 2005
Abbott's HumiraR (Adalimumab) Approved in Europe for Psoriatic Arthritis and Severe Rheumatoid Arthritis
Abbott Laboratories announced that it has received US Food and Drug Administration (FDA) approval to market HumiraR (adalimumab)...

Thursday Oct 06, 2005
Regeneron Discontinues IL-1 Trap Program in Adult RA
Regeneron Pharmaceuticals, Inc (Tarrytown, NY), a biopharmaceutical company with therapeutic candidates in clinical trials for the potential treatment of cancer, age-related eye diseases, and inflammatory diseases, announced...

Thursday Oct 06, 2005
Human Genome Sciences' LymphoStat-Bâ„¢ for Lupus Fails to Meet Primary Endpoints in Phase II Trial

Human Genome Sciences, Inc (Rockville, Md), announced that its investigational drug for lupus, LymphoStat-Bâ„¢, (belimumab) failed to meet the overall primary efficacy endpoints...

Monday Oct 03, 2005
Osteologix's Low-Dose Strontium-Based Compound Shows Bioequivalence to Strontium Ranelate in Phase I Trial
Osteologix, Inc, headquartered in San Francisco, California, announced that its phase I clinical trial of NBS-101...

Monday Oct 03, 2005
Cytori Therapeutics Reports Differentiation of Adipose-Derived Adult Stem Cells to Spinal Disc
Cytori Therapeutics, Inc, along with its collaborators, released data demonstrating that human adipose-derived adult stem cells have the potential to differentiate into cells with the phenotypic traits and DNA expression markers of mature nucleus pulposus cells...

Wednesday Sep 28, 2005
Roche and GSK Tout Efficacy, Safety, and Convenience of Once-Monthly Boniva^R Osteoporosis Therapy at ASBMR Annual Meeting
Roche Pharmaceuticals and GlaxoSmithKline presented 4 posters (2 studies) at the 27^th Annual Meeting of the American Society for Bone and Mineral Research...

Friday Sep 23, 2005
FDA Issues "Non-Approvable Letter" for Pfizer's Injectable COX-2 Drug
Just 1 week after receiving a nonapprovable letter for their new osteoporosis drug lasofoxifene (Oporia), Pfizer Inc announced Tuesday that the Food and Drug Administration (FDA) has issued a nonapprovable letter for parecoxib sodium, an injectable COX-2 inhibitor used to treat acute pain in the postsurgical setting... Pfizer receives FDA non-approvable letter on parecoxib [press release]. PR Newswire; September 20, 2005.

Thursday Sep 22, 2005
US FDA Issues Nonapprovable Letter for Pfizer's Injectable COX-2 Inhibitor
A nonapprovable letter from the US Food and Drug Administration was received by Pfizer Inc for parecoxib sodium, an injectable COX-2 inhibitor used to treat acute pain after surgery...

Wednesday Sep 21, 2005
Johnson & Johnson's Remicade (infliximab) First Biologic Approved by US FDA for Treatment of Ulcerative Colitis
Centocor, Inc, a biotech unit of Johnson & Johnson, has announced that Remicade® (infliximab) has been approved by the US Food and Drug Administration...

Monday Sep 19, 2005
A Leading Rheumatologist Reflects on How Cyclooxygenase Became a Household Word
Just as it appeared that the dust from the great COX-2 controversies had begun to settle, a jury in Texas awarded a plaintiff a judgment against Merck & Co for one quarter of a billion dollars - indeed, for a death that, arguably, was not Vioxx-related.

Monday Sep 19, 2005
Abuse-Resistant Oxycodone Clears Trial
Remoxy, a new oxycodone compound, may change the tide of abuse by making injection or snorting difficult due to its sticky, high-viscosity formulation...

Friday Sep 16, 2005
Generic Equivalents of Sanofi-Aventis' Arava® Now Available for Adult RA

Prasco Laboratories, a privately held pharmaceutical company located in Cincinnati, Ohio, announced...

Friday Sep 16, 2005
Neurochem Initiates Rolling NDA Submission for Fibrillexâ„¢ for AA Amyloidosis
Neurochem Inc announced that it has initiated submission of a rolling new drug application (NDA) to the US FDA seeking marketing approval for Fibrillexâ„¢...

Friday Sep 16, 2005
Pfizer's SERM Lasofoxifene Not Approvable by US FDA
In a brief announcement, Pfizer Inc disclosed that it has received a nonapprovable letter...

Friday Sep 16, 2005
Abatacept Beneficial to Patients with RA Refractory to TNF-α Inhibitors
Abatacept has shown benefit to rheumatoid arthritis patients with inadequate response to tumor necrosis factor (TNF)-α inhibitors, according to the results of a randomized, double-blind study...Genovese MC, et al. N Engl J Med. 2005;353:1114-1123.

Tuesday Sep 13, 2005
Two New Treatments Show Promise in Paget's Disease
Zoledronic acid and osteoprotegerin found to be promising new therapies for the management of Paget's disease... Reid IR, et al. N Engl J Med. 2005;353:898-908; Cundy MD, et al. N Engl J Med. 2005;353:918-923.

Friday Sep 09, 2005
FDA's Advisory Committee Recommends Approval of Bristol-Myers Squibb's Orencia® for RA
Bristol-Myers Squibb Company (Princeton, NJ) has announced that the Arthritis Advisory Committee of the US Food and Drug Administration (FDA)...

Friday Sep 09, 2005
FDA Arthritis Advisory Committee Gives Preliminary Go-ahead to Abatacept
A Food and Drug Administration Arthritis Advisory Committee unanimously recommended approval of Orencia®  (abatacept) Tuesday, stating that the benefits of the costimulation blocker for rheumatoid arthritis (RA) outweighed the risks of serious infections like pneumonia and some cancers.

Friday Sep 09, 2005
Preliminary Data on Genelabs' Prestaraâ„¢ Show Positive Effects on BMD in SLE Patients Taking Glucocorticoids
Genelabs Technologies, Inc, of Redwood City, California, has announced positive results from a preliminary analysis

Monday Aug 29, 2005
Entremed's 2ME2 Generates More Positive Preclinical Data in Arthritis Models
EntreMed, Inc, of Rockville, Maryland, a clinical-stage company developing treatments for cancer and inflammatory diseases...

Sunday Aug 21, 2005
Unigene's Calcitonin-Salmon Nasal Spray Approved for Osteoporosis in US
Unigene Laboratories, Inc, and Upsher-Smith Laboratories, Inc, announced FDA approval of their nasal calcitonin product...

Monday Aug 15, 2005
Abbott's Humira Approved in Europe for Psoriatic Arthritis and Early RA
Abbott Laboratories has received approval from the European Commission to market Humira^R...

Monday Aug 15, 2005
Actonel with Calcium Approved by US FDA for the Prevention and Treatment of Postmenopausal Osteoporosis
The Alliance for Better Health, formed by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals (now a member of the Sanofi-Aventis Group), has announced...

Tuesday Aug 09, 2005
FDA Approves Celebrex for Ankylosing Spondylitis, and an Added Boxed Warning
Pfizer's selective cyclo-oxygenase 2 (COX-2) inhibitor Celebrex (celecoxib) has been approved by the US Food and Drug Administration (FDA) for the relief of the clinical signs and symptoms associated with ankylosing spondylitis

Sunday Aug 07, 2005
Neurochem Initiates Submission of NDA With US FDA for Fibrillexâ„¢ in AA Amyloidosis
Neurochem has announced that it has initiated, under the Continuous Marketing Application Pilot 1 program...

Thursday Aug 04, 2005
Scientists Develop New Technique to Grow Bone In Vivo
In a development that one day may revolutionize spinal and knee-replacement surgery and the treatment of osteoporosis, researchers at Vanderbilt University in Nashville, Tennessee, have demonstrated for the first time that healthy new bone can be grown in one part of the body to repair bony defects at another location... Stevens MM, et al. In vivo engineering of organs: The bone bioreactor. Proc Natl Acad Sci. 2005; scheduled to appear online before print. Available at: http://www.pnas.org/.

Wednesday Aug 03, 2005
PREOSR parathyroid hormone NDA accepted for review by FDA
NPS Pharmaceuticals, Inc, of Salt Lake City, Utah, announced that the US Food and Drug Administration has accepted for review the company's new drug application (NDA) for PREOSR, a recombinant parathyroid hormone (PTH 1-84) for the treatment of osteoporosis in postmenopausal women.

Monday Jul 25, 2005
Government Crackdown on Palladone and Fentanyl Continues to Fuel Fear of Prescribing Pain Medication
Withdrawal of Palladone in the US, the advisory report issued on the fentanyl patch, and the continued DEA scrutiny of doctors who prescribe opioids and other narcotic analgesics may have a chilling effect on the optimal use of these agents for the relief of acute and persistent pain.

Thursday Jul 21, 2005
Nastech's Intranasal PTH1-34 Peptide in Phase I for Osteoporosis
Nastech Pharmaceutical Company Inc. of Bothell, Washington, announced the start of a second clinical study to determine the pharmacokinetics and safety of its investigational intranasal human parathyroid hormone (PTH1-34) drug for the treatment of osteoporosis.

Friday Jul 08, 2005
Genelabs' Prestara^TM  Gains Orphan Drug Exclusivity to Prevent SLE Bone Loss
Genelabs Technologies, Inc, reported that Prestara^TM, a synthetic form of the hormone dehydroepiandrosterone (DHEA), has been granted orphan drug exclusivity by the US Food and Drug Administration (FDA) for the

Wednesday Jun 15, 2005
Etanercept Expands PsA Indication to Include Improvement of Physical Function
Amgen Inc and Wyeth Pharmaceuticals announced that the US Food and Drug Administration (FDA) expanded the marketing approval of Enbrel® (etanercept) to include the improvement of physical function in patients with psoriatic arthritis (PsA).

Thursday Jun 09, 2005
Dr. Gary Williams Weighs in on the Coxib Controversy
Gary Williams MD, PhD, chairman of the department of medicine at Scripps Clinic Medical Group, and co-chair of the symposium Clarifying the Risk/Benefit of COX-2 Selective Inhibitor Use at the 6th EULAR Annual European Congress of Rheumatology, spoke with CIAOMed on Wednesday regarding the current controversy over the fate of the COX-2 inhibitors

Wednesday Jun 01, 2005
More Evidence for the 'FitzGerald Hypothesis' on the Relationship of Coxibs and Cardiovascular Disease Risk
Vascular remodeling may interact with a predisposition to hypertension and atherosclerosis, contributing to the gradual increase in cardiovascular risk during extended periods of treatment with COX-2 inhibitors...Rudic RD, et al. Circ Res. Published online May 19, 2005.

Tuesday May 17, 2005
Infliximab Approved for Treatment of Psoriatic Arthritis
Infliximab joins etanercept as an anti-TNF-α treatment option for patients with active psoriatic arthritis...FDA approves Remicade® for ninth indication: psoriatic arthritis [press release]. Malvern, Pa: Centocor, Inc; May 17, 2005.

Thursday May 12, 2005
More Evidence for Cardiovascular Risk Among Selective and Nive Nonsteroidals
Several weeks after the US Food and Drug Administration called for sweeping changes to the labels of prescription and over-the-counter NSAIDs reflecting a potential cardiovascular risk, a Danish study confirms that they increase the chances of hospitalization for MI...Johnsen SP, et al. Arch Intern Med. 2005;165:978-984.

Tuesday Apr 26, 2005
American College of Rheumatology Responds to the Recent FDA Action on NSAIDs
Citing a lack of evidence implicating OTC and prescription NSAIDs in CV risk, the American College of Rheumatology criticized aspects of the recent FDA decision... American College of Rheumatology letter to Lester M. Crawford, DVM, PhD, acting commissioner of the FDA. April 21, 2005.

Tuesday Apr 26, 2005
Teva Challenges Merck Patent on Fosamax
The longstanding legal battle between Teva Pharmaceuticals Industries Ltd, the Israeli-based generic drug manufacturer, and Merck & Co over the validity and enforceability of Merck's patent on its once-weekly FosamaxR may now be decided by the US Supreme Court.

Monday Apr 11, 2005
FDA Approves Alendronate Sodium/Cholecalciferol (Fosamax Plus DR) for Osteoporosis; the Only Bisphosphonate With a Weekly Dose of Vitamin D
Merck & Co, Inc, received marketing approval from the US Food and Drug Administration for its once-weekly tablet containing alendronate sodium (FosamaxR) and vitamin D3 (cholecalciferol) for postmenopausal women with osteoporosis.

Friday Apr 08, 2005
Thalidomide May Play a Role in Treatment of Refractory Radiculopathic Pain
Banned from use in the 1960s due to its teratogenic effects, thalidomide is being reexamined as a treatment for inflammatory and other types of disorders... Presented at the 24th Annual Scientific Meeting of the American Pain Society; March 30-April 2, 2005; Boston, Massachusetts

Thursday Apr 07, 2005
FDA Orders Valdecoxib (Bextra) Withdrawn, Citing No Added Advantage
The agency also mandated black box warnings for celecoxib and stricter label warnings on traditional NSAIDs, including over-the-counter products... US Food and Drug Administration teleconference April 7, 2005.

Wednesday Mar 30, 2005
FDA Approves Monthly Ibandronate for Treatment and Prevention of Osteoporosis
The new formulation simplifies osteoporosis drug therapy and addresses problems of adherence among patients using bisphosphonates

Friday Mar 25, 2005
Genetic Variation Helps Predict Response to Etanercept in Rheumatoid Arthritis
As the FDA takes action to speed the clinical application of pharmacogenetics, the possibility of personalized medicine for RA patients got a boost from a new study showing that a polymorphism in TNF-α affects the response to etanercept therapy...Kang CP, et al. Rheumatology. 2005;44:547-552.

Tuesday Mar 15, 2005
Trials of Gout Drug Febuxostat Demonstrate Promising Efficacy
Results of Phase II and Phase III studies of the novel xanthine oxidase inhibitor suggest that it may play an important role in treating hyperuricemic patients with renal insufficiency and allopurinol hypersensitivity...Becker MA, et al. Arthritis Rheum. 2005;52:916-923.

Monday Mar 14, 2005
Accelerated FDA Approval Unlikely for La Jolla Pharmaceutical's Riquent.
La Jolla Pharmaceutical Company (LJPC) of San Diego, California, announced earlier this month that RiquentR (abetimus sodium), the company's treatment for lupus renal disease, is unlikely to receive an accelerated approval.

Friday Feb 25, 2005
The Future of Spinal Surgery: Artificial Discs and Bone Growth Factors Show Promise
PCM cervical discs, Charité lumbar discs, and BMPs demonstrate improved outcomes and greater patient satisfaction as alternatives to traditional spinal fusion surgery...72nd Annual Meeting of the American Academy of Orthopedic Surgeons; February 23, 2005.

Saturday Feb 19, 2005
FDA Panel Splits 17 to 15 in Favor of Putting Rofecoxib Back on the Market
An FDA advisory panel recommends a strong black box warning for cardiovascular risk, dose restrictions, and strict guidelines to indications for use of Vioxx...US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 18, 2005.

Friday Feb 18, 2005
FDA Advisory Panel Votes to Keep Pfizer COX-2 Inhibitors Celecoxib and Valdecoxib on the Market
An FDA advisory panel concluded today that while safety concerns clearly exist with celecoxib and valdecoxib, their overall benefits outweigh potential CV risks... US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 18, 2005.

Friday Feb 18, 2005
Public Outcry Over Embattled Pain Relievers at FDA Advisory Panel Hearing
Some called for the withdrawal of all coxibs, while others pleaded for a return of the withdrawn rofecoxib (Vioxx) during public testimony at the FDA advisory meeting... US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 17, 2005.

Friday Feb 18, 2005
Despite Proven GI Benefits, Problems Predicted for Newest Coxibs Seeking FDA Approval
Two coxibs currently in the approval pipeline are likely to face substantial hurdles as an FDA advisory panel determines the fate of the COX-2 inhibitor class...US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 17, 2005.

Friday Feb 18, 2005
European Medicines Agency Calls Cardiovascular Risk a Class Effect of Coxibs
EMEA calls for stricter labeling and restricted use for COX-2 inhibitors... will the FDA follow suit?  EMEA press release. London, UK; February 17, 2005.

Thursday Feb 17, 2005
Pfizer, Merck & Co Grapple Over Cardiovascular Risk Associated With Coxibs
With the fate of a drug class on the line, all eyes are on an FDA advisory panel as they assess the data on coxibs and make recommendations that could lead to a labeling change or their withdrawal from the market... FDA joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 16, 2005.

Thursday Feb 17, 2005
FDA Whistleblower Cites Unpublished Data on Dose-Dependent Cardiovascular Risk of Coxibs
The FDA advisory panel on COX-2 inhibitors heard testimony today from a leading voice in the movement to restrict their use... US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 16, 2005.

Tuesday Jan 25, 2005
Three New Studies Further Elucidate Risks and Benefits of Coxibs
Newly published study findings from CRESCENT show that rofecoxib significantly increases 24-hour blood pressure after 6 weeks of therapy, while celecoxib and naproxen do not; two other published studies address COX-2 risks and benefits... Sowers JR, et al. Arch Intern Med. 2005;165:161-168.

Monday Jan 24, 2005
Continuing Concerns of the Cardiovascular Risks of the COX-2s
As the European Medicines Agency is set to determine the fate of COX-2s in the European community and the US Food and Drug Administration readies for a rare advisory meeting in mid-February, the journal Circulation has presented a meta-analysis of two clinical trials that provide further evidence that valdecoxib increases cardiovascular risk in CABG patients, including a study that provides a better understanding of the mechanisms in these agents that may accelerate the atherogenic process& Egan KM, et al. Circulation. 2005; 111:334-342.

Friday Jan 21, 2005
The Promise and Peril of the Next Generation of COX-2 Inhibitors
CIAOMed continues its series on the impact of the withdrawal of rofecoxib (VioxxR) from the worldwide market. The first installment (CIAOMed.org; November 9, 2004) discussed possible mechanisms of the cardiovascular (CV) risk observed with rofecoxib, and whether they apply to other selective cyclooxygenase-2 (COX-2) inhibitors. The second (CIAOMed.org; December 10, 2004) examined the impact of recent disclosures about COX-2s and CV risk on patient management. This third and final installment focuses on the clues to CV risk profiles of the second-generation COX-2 inhibitors and the role these newer drugs will play if they are approved for marketing in the US& Brune K, Hinz B. Scand J Rheumatol. 2004;33:1-6.

Wednesday Dec 22, 2004
UVA-1 Light Useful as Adjuvant Therapy for Systemic Lupus Erythematosus
A new study by Dutch researchers has found that UVA-1 cold light therapy significantly decreases validated disease activity indices in patients with moderately active systemic lupus erythematosus (SLE) without causing significant adverse effects... Polderman MCA, et al. Rheumatology. 2004;43:1402-1404.

Tuesday Dec 21, 2004
Cancer-Prevention Trial Reveals Elevated Cardiovascular Risk Associated With Celebrex
National Cancer Institute study results, which showed a heightened cardiovascular risk versus placebo among patients taking the COX-2 inhibitor celecoxib at up to 4 times higher than recommended doses, runs counter to recent evidence that the agent may have cardioprotective properties in some arthritis patients... Kimmel SE, et al. Ann Intern Med. 2005;142(3).

Thursday Dec 16, 2004
Pfizer's COX-2 Agent to Include Updated Risk Warnings on Label
The FDA announces important new information on risks of CV adverse events in some postsurgical cardiac patients and potentially life-threatening skin reactions associated with use of valdecoxib...US Food and Drug Administration. December 9, 2004.

Friday Dec 03, 2004
Leflunomide Associated With Lower Rate of Adverse Events Than Other DMARDs, Large Cohort Study Finds
Study of more than 40,000 patients showed that the AE profile of leflunomide, alone or in combination with methotrexate, was comparable to that of other DMARDs used in the treatment of rheumatoid arthritis...Cannon GW. J Rheumatol. 2004;31:1906-1911.

Wednesday Nov 24, 2004
Gender Bias May Exist in the Recognition and Treatment of Osteoporosis in Men
Although men have higher vertebral fracture rates than women, they may not get screening and treatment for osteoporosis as often or as early... Sawka AM, et al. J Rheumatol. 2004;31:1993-1995.

Tuesday Nov 09, 2004
COX-2s, Pain Relief, and Cardiovascular Risk: Where Do We Go From Here?
In the first of a 3-part series, CIAOMed will examine possible underlying mechanisms that may be responsible for elevated cardiovascular risk in select COX-2 inhibitors and whether such explanations extend to all coxibs. Subsequent installments will examine how to manage patients in light of the new reports and the future of this frequently used drug class... Simon LS, Strand V. Cleve Clin J Med. 2004;71:849-856.

Thursday Nov 04, 2004
TNF-α Blocker Etanercept Reduces Daytime Sleepiness in Patients with Sleep Apnea
Pilot trial is reportedly the first to demonstrate that neutralizing tumor necrosis factor-α activity is associated with a significant reduction of daytime somnolence in obese patients with sleep apnea... Vgontzas AN, et al. J Clin Endocrinol Metab. 2004;89:4409-4413

Thursday Nov 04, 2004
Next generation COX-2 Inhibitor Arcoxia Receives FDA Approvable Letter
Final approval of etoricoxib must await FDA review of additional safety and efficacy data... Baraf HSB, et al. Presented at: Annual Meeting of the American College of Rheumatology; San Antonio, Tex.

Wednesday Nov 03, 2004
Merck Withdraws NDA for COX-2 Inhibitor Arcoxia

Just days after receiving an FDA "approvable letter", the company has withdrawn the new drug application for etoricoxib until additional safety and efficacy data are available...

Wednesday Oct 20, 2004
New Phase III Trial With Abatacept Gives Hope to Methotrexate Nonresponders

A phase III clinical trial reported that nearly half of rheumatoid arthritis patients receiving monthly injections of the T-cell inactivator abatacept achieved at least a 50% reduction in symptoms... Kremer J, et al. Presented at: Annual Meeting of the American College of Rheumatology; October 19, 2004; San Antonio, Texas.

Tuesday Oct 19, 2004
APPROVe Study Shows Two-Fold Increased Risk of Coronary Events with VIOXX

Cardiovascular events in the placebo arm of the trial appeared to stop occurring after 18 months, while they continued among patients taking rofecoxib, according to the first detailed report of the drug's withdrawal ...

Monday Oct 04, 2004
FDA Approves Etanercept as Pre-Filled Syringe, Infliximab as First-Line Therapy for Moderate to Severe RA

The FDA has approved etanercept (Enbrel) as a pre-filled syringe formulation for once weekly use, and granted approval for a supplemental labeling change stating that the medication can induce a major clinical response in patients with rheumatoid arthritis (RA). In another regulatory decision, the FDA has approved the use of infliximab (Remicade) in combination with methotrexate as a first-line treatment for patients with RA.

Friday Oct 01, 2004
Rofecoxib (Vioxx) Withdrawn, APPROVe Trial Discontinued Early
A study to determine the drug's value in preventing colorectal polyp recurrence showed that patients on rofecoxib had a higher risk of cardiovascular events than did those on placebo.

Wednesday Sep 15, 2004
Advances in anti-TNF Therapy for RA

Two studies give insight regarding the time after RA onset to introduce anti-TNF therapy, and which doses to use to get an optimal response. (Baumgartner SW, et al. J Rheumatol. 2004;31:1532-1537; Stern R, Wolfe F. J Rheumatol. 2004;31:1538-1545.)

Monday Aug 30, 2004
SLE Researchers Encouraged to Use Biomarkers, Surrogate Markers as Study Endpoints; New Research Shows B-Cell Depletion to Have Role in SLE Therapy
(Schiffenbauer J, et al. Arthritis Rheum. 2004;50:2415-2422; Looney RJ, et al. Arthritis Rheum. 2004;50:2580-2589.)

Tuesday Aug 03, 2004
ReGen Biologics Begins Modular FDA Pre-Market Approval Submission for CMI Product

The Collagen Meniscus Implant (CMI) is the first application of ReGen's proprietary tissue growth technology.