| FDA Approves Amgen's Prolia Drug Amgen received FDA approval for Prolia to treat osteoporosis in postmenopausal women, in a surprise decision that comes almost two months earlier than expected. online.wsj.com |
Clarient Achieves Profitability and Continues Growth Trajectory in the Second Quarter of 2010 (PR Newswire) Clarient, Inc. , a premier anatomic pathology and molecular testing services resource for pathologists, oncologists and the biopharmaceutical industry, today reported financial results for the second quarter ended June 30, 2010. Â Second quarter 2010 net revenue was $28.7 million, a 21 percent increase over the $23.7 million net revenue in the 2009 second quarter and a sequential increase of nearly eight percent over the $26.6 million in the first quarter of 2010. Â us.rd.yahoo.com |
FDA Rightfully Rethinks Approval for Genentech / Roche Breast Cancer Drug Derek Lowe submits: As if one were needed, here's an example of how rough the state of current oncology therapy is today. Avastin, the antibody-based therapy from Genentech (DNA)/Roche (RHHBY.PK), had been approved (conditionally) for advanced breast cancer, based on a study showing about a five-month benefit in tumor growth. (Everyone should already know that such numbers, for many types of cancer, are indeed enough to get an indication approved, and everyone has, I'm sure, already decided what they think about that.) But the approval came with a requirement to follow up on those results. For one thing, the study that led to conditional approval didn't show much of a survival benefit, making the approval itself controversial at the time. The follow-up work has shown that those initial results were right on target. For metastatic breast cancer, Avastin has something like a month-and-a-half survival benefit. That probably doesn't outweigh the risks, and the FDA is seriously thinking about revoking that earlier approval.Complete Story » seekingalpha.com |
BioClinica Appoints James W. Lovett to Its Board of Directors [Business Wire] - BioClinicaâ„¢, Inc., , a leading provider of clinical trial management services, today announced that it has appointed James W. Lovett to its Board of Directors, increasing the size of the Board to nine members. us.rd.yahoo.com |
Study: Pill Slashes Risk of HIV Infection A study shows an existing antiretroviral drug can also ward off HIV infections in what researchers call a major advance in the quest to find medicines that prevent rather than simply treat AIDS. online.wsj.com |