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Parexel to Restructure Early-Phase R&D as Shares Plunge

By John Carroll Shares of Parexel International took a beating this morning after the CRO noted a shortfall in early-phase research work that is triggering a restructuring in that segment of its drug research business. Parexel, one of the top CROs in the business, also cut its outlook on 2011. And investors responded by taking …

Pfizer Lays Out its R&D Survival Strategy

By John Carroll While Wall Street has been transfixed by signs that Pfizer CEO Ian Read is preparing to sell off large chunks of its business so it can concentrate on pharmaceutical sales and new drug development to replace the blockbusters slated to lose patent protection, Read has been pushing full-steam-ahead on plans to radically …

AZ Orders in the Wrecking Ball for Sprawling R&D Hub

By John Carroll Say goodbye to AstraZeneca’s decade-old research hub in Delaware. Defying local economic development officials, the pharma company–which is undergoing a top-to-bottom restructuring of its global development efforts–plans to demolish 450,000 square feet of space at its North American headquarters. The three buildings marked for destruction, part of a sprawling campus in Fairfax, …

CROs Scramble as Big Pharma Lines Up Strategic Partnerships

By John Carroll With Pfizer ($PFE) pushing a top-to-bottom restructuring on the R&D side as it carves billions of dollars from its R&D budget, analysts at Jefferies & Co. say that the pharma giant will soon whittle down its list of vendors, helping drive a broad consolidation of the CRO field as Big Pharma lines up …

Study: Rate of Drug Approvals Dropping

By Maureen Martino Want proof that achieving FDA approval is more difficult than in the past? A study released by the BIO and BioMedTracker that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previously the rate of approval were one …

What Does Biotech Really Suffer From? Information Overload, or Underload?

By Stewart Lyman Cognitive dissonance is defined as “an uncomfortable feeling caused by holding conflicting ideas simultaneously.” I’m suffering from a serious case of discomfort as I try to figure out which is the bigger problem facing biotech scientists: too much information, or too little. Information overload is a serious issue in biomedical research, if not …

Sanofi’s GLP-1 Drug Hits Promising Marks in PhIII Diabetes Trial

By John Carroll Sanofi-Aventis’ GLP-1 diabetes drug lixisenatide impressed analysts with a solid set of top-line results demonstrating its effectiveness–in combination with the bestselling Lantus–for controlling blood sugar. Adding a daily injection of lixisenatide helped Type 2 diabetes patients who had trouble controlling the disease with basal insulin alone. Analysts at Bryan, Garnier has already …

Acceleron Inks $498M Pact With Shire for Lead Muscle Drug

By John Carroll Cambridge, MA-based Acceleron has inked a $498 million development deal with Shire covering the ex-U.S. rights to its closely watched lead therapy, ACE-031. Shire is paying $45 million upfront and committing itself to up to $453 million more in a slate of milestones to snag the international marketing rights to the therapy–as …

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