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      NICE recommends additional Sutent use; FDA gives nod to Oculus gel

      Posted AtFiercepharma.com

      > The U.K.'s National Institute for Health and Clinical Excellence (NICE) recommended reimbursement for Pfizer's Sutent (sunitinib malate) as a second-line treatment for patients with advanced gastrointestinal stromal tumor.

      > Oculus Innovative Sciences said FDA approved its Microcyn skin and wound gel as both a prescription and over-the-counter formulation, sending shares up 70 percent before the bell.

      > A federal jury in Phoenix awarded $11 million in damages to a medical and pharmaceutical supplies salesman and his new company after they countersued McKesson Medical Surgical Inc.

      > FDA gave the nod to the Astellas transplant drug Prograf (tacrolimus) for prevention of organ rejection in kidney transplant recipients.

      > Two weeks after telling investors about its efforts to raise new funds to continue to operate the company, San Diego-based Metabasis Therapeutics today unveiled plans to slash its remaining staff by 85 percent. And raised the prospect of shutting the company down.

      > Industry group ISPE is partnering with the China Centre for Pharmaceutical International Exchange (CCPIE) to bring training courses tailored to the needs of the Chinese pharmaceutical industry.

      > Indian drug makers are attempting to respond to a prevalence of extensive manual operations, islands of automation, disparate information systems, paper records that no longer meet business and regulatory requirements, and isolation of manufacturing systems from business systems, according to research from ARC Advisory Group.

      > One of Genentech's star cancer drug development specialists is moving into the top job at Cambridge, MA-based Agios Pharmaceuticals, a start-up developer that scored a $33 million Series A last summer.

      > With its researchers preparing to start human testing on an A/H1N1 vaccine, San Diego-based Vical said that Special Situations Fund had agreed to invest $4.6 million in the company, adding to the $15.4 million that the company raised last week from Federated Kaufman and another investor.

      > With the debate over biosimilars coming back to a boil as lawmakers hammer out the broad outlines of a major healthcare reform bill, the Biotechnology Industry Organization devoted close to $2 million to lobbying in the first quarter.

      > Cougar Biotechnology revealed some new clinical trial data this morning that helps explain why Johnson & Johnson is willing to pay nearly a billion dollars for the company.

      > Three experimental vaccines applied in a new way were effective in preventing ear infections in an animal study. And the researchers involve say that the new method could offer a potentially "transformative" approach to vaccine delivery.

      > Novartis has struck a deal with Takeda that will allow the Swiss pharma giant entry into the world's third largest vaccine market.

      And Finally... Special stockings commonly given to stroke patients to prevent blood clots don't work, a new study reported Wednesday.

      June 04, 2009


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