BioPharm Business News and Perspectives

Thursday, January 08, 2009 BioMarin Bets $289 Million That Riquent Works in Lupus Nephritis
BioMarin has bet $289 million that the third time is the charm for La Jolla Pharmaceutical's experimental lupus drug Riquent^® (abetimus sodium), which failed to reach primary endpoints in 2 previous clinical trials...

Thursday, December 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...

Thursday, December 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...

Friday, November 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, November 20, 2008 BioLineRx, Yissum Sign a Licensing Agreement for the Development of an Anti-Leptin Compound for the Treatment of IBD
BioLineRx signed an exclusive license agreement with Yissum Ltd to develop and commercialize BL-5040, an antagonist of leptin with anti-inflammatory properties for the treatment of inflammatory bowel disease (IBD)...

Tuesday, November 18, 2008 Phosphagenics’ Transdermal Diclofenac Enters Phase I Clinical Trial
The trial will compare the bioavailability and penetration of the topically applied Voltaren^® gel (1% diclofenac sodium topical gel, Novartis), and Phosphagenics’ TPM/diclofenac (at 1% and 2% diclofenac concentrations) for the targeted delivery of the NSAID diclofenac...

Friday, November 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, November 12, 2008 Novartis’ ACZ885 Phase III Data Show Rapid, Sustained Clinical Remission in Children and Adults with CAPS, a Group of Rare, Potentially Life-Threatening Autoinflammatory Diseases
Novartis also announced that preliminary results of a phase I/II study in systemic juvenile idiopathic arthritis showed that most patients treated with ACZ885 achieved substantial clinical improvement within 15 days...

Monday, November 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...

Tuesday, November 04, 2008 Genentech, Biogen Idec Rituxan Phase III Data in RA Patients Showed Patients who Received Fixed Interval Re-Treatment Maintained Treatment Response; Positive Phase III Data Also Reported for Rituxan plus MTX in Biologic-Naïve RA Patients, Immune Response in Rituxan-Treated Patients Yielded Mixed Results in Phase II Study
Rituxan, in combination with MTX, is indicated to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist therapies...