PHARMACY

FDA seeks more for its fiscal budget

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration is asking for 19% more than it got last year out of the fiscal year 2010 budget, the agency announced Thursday.

The agency is requesting a $3.2 billion budget from the Obama administration, covering the period from Oct. 1, 2009 to Sept. 30, 2010 and including increases of $295.2 million in budget authority and $215.4 million in industry user fees.

The budget would include $166.4 million to product medical products, including drugs, devices, vaccines and others. Anticipating a regulatory pathway for biosimilars, the agency has also requested $5 million to give the FDA a new authority to approve biosimilars and to develop policies to allow Americans to buy drugs approved in other countries. Another $259.3 million would go to food safety.

“This historic increase in the FDA’s budget is a great investment in public health,” FDA acting commissioner of food and drugs Joshua Sharfstein stated.

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Pfizer signs licensing agreement with Wisconsin Alumni Research Foundation

BY Alaric DeArment

MADISON, Wis. The world’s largest drug maker has signed a licensing agreement with a patenting and licensing organization for the Univeristy of Wisconsin-Madison to use human embryonic stem cell patents to develop new drug therapies.

Pfizer said that under its agreement with the Wisconsin Alumni Research Foundation, the license will the company the rights to work with hES cells for drug research and discovery.

“Our license with WARF provides us with information and materials that will allow us to use their cell lines to explore a whole range of therapies,” Pfizer Regenerative Medicine chief scientific officer Ruth McKernan said. “Stem cells can be used to create specialized human tissue. Our scientists will determine how new medicines may be able to improve the way stem cells regenerate damaged tissues.”

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GlaxoSmithKline to sell U.S. Wellbutrin XL rights to Biovail Corp.

BY Alaric DeArment

RESEARCH TRIANGLE PARK, N.C. A drug maker announced Wednesday that it would give up U.S. rights to the extended-release formulation of a popular antidepressant.

GlaxoSmithKline said it would divest full commercial rights to Wellbutrin XL (bupropion hydrochloride) in the United States, selling it to Biovail Corp. for $510 million. Generic competition to Wellbutrin XL began at the end of 2006 for the 300-mg tablets and during the second quarter of 2008 for the 150-mg tablets. The drug had sales of $60 million in first quarter 2009.

“We are actively reshaping our U.S. business and managing the transition occurring in our product portfolio,” GSK president North American pharmaceuticals Deirdre Connelly said. “This transaction is one of a series of actions we are taking to maximize the value of our current assets and to enable us to resource and invest in new products and upcoming launches.”

Under the terms of the agreement, GSK will transfer the regulatory approval application and trademark for Wellbutrin XL to Biovail for use in the United States, though it will retain rights to the drug for other countries.

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