| 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 |
Why Relaxing Is Hard Work Some people are so addicted to the adrenaline rush of stress that they take on too much. Put them on a beach for a week, and it's no wonder they can't relax. online.wsj.com |
Clarient Can Profit From Rise of Individualized Medicine M.E. Garza submits: This small-cap company may be poised to be a long-term leader in cancer diagnostics and molecular testing. It combines innovative diagnostic technologies with world-class pathology expertise to assess and characterize cancer. The rise of individualized medicine as the new direction in oncology has created the need for a centralized resource providing leading diagnostic technologies, such as flow cytometry and molecular testing. Clarient Inc. (CLRT) has a state-of-the-art commercial cancer laboratory, providing the most advanced oncology testing and diagnostic services. It's also developing new, proprietary “companion” diagnostic markers for therapeutics in breast, prostate, lung and colon cancers, and leukemia/lymphoma. Clarient has a wonderful and comparatively inexpensive series of cancer diagnostic platforms that enables clinicians to determine the most effective therapies available for cancers having various genetic expressions. Its sales have been increasing at up to 20% a year compounded. Much of CLRT’s IP comes from its acquistion of Applied Genomics, Inc in December 2009. Complete Story » seekingalpha.com |
Desperate for Cure, Doctor Heals Himself Frustrated by lack of interest from drug companies, a Belgian doctor pursues his own research to help cure his rare neurological condition. 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 |