FDA fails to approve J&J drug; Alnylam CSO departure raises suspicions;

> J&J said on Friday that U.S. regulators had failed to approve its experimental epilepsy drug carisbamate. In a tight-lipped statement, J&J said only that it is reviewing the FDA's response letter and will respond as quickly as it can. Release

> After the market closed on Friday Alnylam reported that its CSO Jack Schmidt was leaving after less than a year on the job. That had analyst Simos Simeonidis worried. He writes: "The main reason this would resonate negatively with investors, of course, is that it could be interpreted as "this guy saw something he didn't like there and bolted." Release | Story

> Nanotherapeutics has been awarded a $30.9 Million, five-year contract from the National Institute of Allergy and Infectious Diseases to develop an inhaled version of the injectable antiviral drug, cidofovir, for smallpox. Release

> A new swine flu jab has been given to the first round of clinical trial volunteers with no signs of serious side effects. The National Institute of Allergy and Infectious Diseases is overseeing the trials as manufacturers prepare to make up to 200 million doses of H1N1 vaccine for the U.S. market this fall. Article

> FDA regulators have agreed to review Cell Therapeutics' NDA for pixantrone, a new therapy for relapsed, aggressive non-Hodgkin's lymphoma. Story

Pharma News

> Off-label prescribing--a normal practice among physicians--is at least partially fueled by a lack of knowledge about a drug's approval status, a new survey says. Report

> Shares of Lundbeck are on the rise today on the news that the FDA has approved the drugmaker's anti-epilepsy drug Sabril. Report

> UCB is expanding in Germany with a new Novartis licensing agreement for cardiovascular and diabetes products. Report

> Seven California pharmacies don't want to see Pfizer's $68 billion buyout of Wyeth succeed, and they've filed suit against the drugmaker to protest the deal. Report

Biotech IT News

> Do your homework before selecting a cloud service provider. That's the message from those who know. Report

> In completing its acquisition of the interactive voice and web response services business of Covance last week, Phase Forward has completed two acquisitions, launched a product and issued two new software releases in the past four months. Report

> Two online forums--on biobanking and stem cells--have launched on the iBridge Network. Report

> Tools to find "intersections in science" that can speed drug discovery are the objective of a semantic technology effort now underway by Alitora Systems and The J. David Gladstone Institutes. Report

Special Report: Fierce Cloud Services for Biopharma R&D. List 

And Finally... Flasks, beakers and hot plates may soon be a thing of the past in chemistry labs. Instead of handling a few experiments on a bench top, scientists may simply pop a microchip into a computer and instantly run thousands of chemical reactions, with results - literally shrinking the lab down to the size of a thumbnail. Report

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