| Roche, Biogen Idec Scrap Development of Arthritis Drug: Biotech's LatestMishaps The Burrill Report submits: Roche (RHHBY.PK) and Biogen Idec (BIIB) say they will discontinue development of late-stage ocrelizumab in rheumatoid arthritis. The decision follows an analysis of the efficacy and safety results from the program that led the companies to conclude the antibody carried too great a risk to rheumatoid arthritis patients compared to benefits and available treatment options. The ocrelizumab rheumatoid arthritis program included four late-stage studies. Ocrelizumab is also being evaluated for relapsing remitting multiple sclerosis in a mid-stage trial. In March, Roche and Biogen Idec announced the suspension of treatment in the ocrelizumab rheumatoid arthritis program. This decision followed a recommendation from the independent ocrelizumab RA & Lupus Data and Safety Monitoring Board. The data safety monitoring board concluded that the safety risk outweighed the benefits observed in these specific patient populations at that time based on an infection related safety signal that included serious infections, some of which were fatal, and opportunistic infections. Subsequently, the U.S. Food and Drug Administration placed the rheumatoid arthritis studies on clinical hold. Teva Pharmaceutical Industries (TEVA) said its experimental to treat Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s disease, failed in a mid-stage trial. The trial was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in ALS patients. Teva said the trial showed Talampanel was safe for ALS patients, but the study did not meet its primary endpoint. Complete Story » seekingalpha.com |
Geron Corporation Q1 2010 Earnings Call Transcript Geron Corporation (GERN)Q1 2010 Earnings CallApril 30, 2010 11:00 a.m. ESTComplete Story » seekingalpha.com |
Lexicon Pharmaceuticals Incorporated Q2 2010 Earnings Call Transcript Lexicon Pharmaceuticals Incorporated (LXRX)Q2 2010 Earnings CallAugust 9, 2010 11:01 amComplete Story » seekingalpha.com |
Orexigen Signs Obesity-Drug Pact With Takeda Orexigen signed a North American partnership for its experimental obesity drug Contrave with Takeda Pharmaceutical. online.wsj.com |
Pfizer’s Big Generics Bet The Burrill Report submits: By Michael FitzhughPfizer (PFE) is embracing new opportunities in the anticipated $920 billion generic medicines marketplace, leveraging the accomplishments of new partners to fortify its offerings in two key emerging markets, Brazil and India. Complete Story » seekingalpha.com |