BioPharm Business News and Perspectives

Thursday, October 30, 2008 Merck, Japan Tobacco in Osteoporosis Drug Deal
Merck and Japan Tobacco announced a worldwide licensing agreement to develop and commercialize JTT-305, an investigational oral osteoanabolic agent for the treatment of osteoporosis...

Monday, October 27, 2008 VGX Initiates Follow-On, Phase I, Multiple Ascending Dose Study for Oral Anti-Inflammatory Drug Targeting RA and Type 1 Diabetes
VGX Pharmaceuticals announced phase I study results that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans...

Wednesday, October 22, 2008 Biogen Idec Reports Top-Line Results From Phase II Clinical Trial of Baminercept in RA; Will Discontinue Development in RA
The phase II trial of baminercept in RA patients who have had an inadequate response to conventional therapy with a disease-modifying antirheumatic drug did not meet its primary endpoint...

Tuesday, October 21, 2008 Centocor Reports Efficacy of Remicade^® vs Azathioprine in Treatment of Crohn’s Disease
Azathioprine is not approved in the US for the treatment of CD but is approved in some countries outside the US and is widely used by gastroenterologists and other physicians in the US to treat CD patients...

Friday, October 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, October 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, October 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, October 08, 2008 Incyte's Topical JAK Inhibitor Shows Positive Proof-of-Concept Results in Two Phase IIa Clinical Trials in Patients with Mild-to-Moderate Psoriasis; Phase IIb Expected to Start October 2008
Results from the first study demonstrated that INCB18424 was well tolerated at all doses and significantly improved overall total lesion score (erythema + scaling + thickness)...

Wednesday, October 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...

Monday, September 29, 2008 Abbott Reports Continuous Treatment With Humira^® Achieves Superior Long-Term Efficacy for Psoriasis Patients in the US and Europe Versus Interrupting Treatment
The findings were from the company's pivotal 52-week REVEAL study and the period of open-label treatment that followed...