TOP 100 MEDICAL SITES
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| BioCryst Pharmaceuticals, Inc. Q1 2010 Earnings Call Transcript BioCryst Pharmaceuticals, Inc. (BCRX)Q1 2010 Earnings CallApril 28, 2010 11:00 am ETComplete Story » seekingalpha.com |
PPD Names Mike Wilkinson as Executive Vice President and Chief Information Officer, Paul Colvin as Executive Vice President of Global Clinical Development (Business Wire) WILMINGTON, N.C.----PPD, Inc. today announced it has appointed Mike Wilkinson, Ph.D., as executive vice president and chief information officer and Paul Colvin as executive vice president of global clinical development effective June 30. us.rd.yahoo.com |
Trading Off of the FDA Mike Havrilla submits:Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...Cell Therapeutics (CTIC) announced a five-year clinical and commercial supply agreement with NerPharMa for pixantrone, and the Company plans to submit a Marketing Authorization Application (MAA) in Europe while initiating a Phase 3 study in the US in patients with relapsed or refractory aggressive non-Hodgkins lymphoma (NHL) by year-end 2010.Complete Story » seekingalpha.com |
Court Won't Reconsider Ruling on Drug-Patent Deals A federal appeals court declined to reconsider its April ruling that upheld the legality of pharmaceutical-patent settlements that can delay the introduction of generic drugs. online.wsj.com |
Will the FDA Give Vivus More Time Before the Final Judgment on Qnexa? David Greene submits:What a conundrum for Vivus (VVUS) and the FDA.Vivus announced last week what I am sure they wish they could have announced prior to the FDA panel meeeting in July--the results of a two year study monitoring 675 obese or overweight patients using the company's Qnexa drug, showing an average weight loss of 11.4 percent with much less threatening side effects than what was presented with the results of a one year study. The one year trial ended up with the Food and Drug Administration panel in July recommending against approving Qnexa due to concerns of negative side effects such as memory lapses, suicidal thoughts, heart palpitations, and birth defects.Complete Story » seekingalpha.com |