| FDA Tells Pfizer It Failed to Properly Monitor Trial: Biotech's Latest Mishaps The Burrill Report submits: The U.S. Food and Drug Administration sent a warning letter to Pfizer (PFE) about overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, Reuters reported. The FDA told Pfizer that it failed to ensure proper monitoring of the trial in which several children given overdoses experienced tremors, restless legs and other complications. The company is seeking to market the drug to children with bipolar disorder. While the study in question ended in 2007, the FDA is concerned Pfizer has not done enough to ensure the problem does not happen again. In its letter, the FDA said the company did not properly monitor the study and "as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner.” Pfizer said it is committed to addressing the concerns. It says that many items cited in the letter occurred as long as four years ago. Pfizer has instituted several new measures designed to improve monitoring and execution of clinical trials, it said. Phenomix said Forest Laboratories (FRX), which was collaborating with the San Diego-based biopharmaceutical in the development of the experimental diabetes drug dutogliptin, said it was ending its development and commercialization agreement because of “business reasons.” The decision by Forest comes in the wake of positive top-line results from a six-month late-stage trial comparing dutogliptin 400mg and 200mg once daily as monotherapy versus placebo for the treatment of patients with type 2 diabetes mellitus. The deal announced in October 2008 included an upfront payment to Phenomix of $75 million and milestone payments that could have pushed the total to $340 million. Complete Story » seekingalpha.com |
Cord Blood America Could Increase Sales With New Marketing Strategy: Analyst (PR Newswire) Cord Blood America, Inc. announced today that a new analyst report prepared by Francis Gaskins , well known as one of the nation's leading IPO analysts, commented favorably in its Valuation Summary on Cord Blood America's planned new marketing strategy. us.rd.yahoo.com |
Specialty Pharmaceutical Stocks Currently Trading At 9X - 10X Earnings; CIO Sees Deals In The Sector (Wall Street Transcript) 67 WALL STREET, New York - July 8, 2010 - The Wall Street Transcript has recently published its Large Cap Value & Other Investing Strategies Report offering a timely review of the sector to serious investors and industry executives. This Special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online. us.rd.yahoo.com |
Sanofi-Aventis and Genzyme: Walking Away? Derek Lowe submits: Here's a roundup of the latest reports on the potential Genzyme (GENZ) takeover. For one thing, it looks as if people on the inside are talking again, after a good period of silence. And for another, it looks as if Sanofi (SNY) is applying the pressure: no deal above $70/share. Either Genzyme's board agrees to entertain such an offer, or they get to explain to the shareholders why they think it's just too low. Sanofi-Aventis, for its part, may well be actually thinking about walking away, which is a move that I'd applaud. Complete Story » seekingalpha.com |
Nanoneedles Deliver Drugs China's Suzhou Natong Bionanotechnology hopes its drug-delivery device could help eliminate the danger to doctors and nurses of accidental sticking and allow greater product lifetime for pharmaceutical companies. online.wsj.com |