FDA receives letter from Sen. Grassley questioning Avandia decision
WASHINGTON Senate Finance Committee Ranking Member Chuck Grassley, R-Iowa, is questioning the Food and Drug Administration about an alleged vote by its Drug Safety Oversight Board to keep GlaxoSmithKline’s Type 2 diabetes drug Avandia on the market.
Committee investigators learned the FDA convened its DSOB Oct. 2 and the board voted 8 to 7 to keep Avandia on the market, Grassley wrote in a letter to FDA Commissioner Andrew von Eschenbach. However, he said, the FDA has not notified the public of the vote.
Grassley is requesting information on the FDA’s internal policies and procedures regulating the DSOB and stipulating when information from the board can be released to the public.
Sandoz completes $10 million expansion of N.C. facility
WILSON, N.C. Sandoz recently completed the major phase of its Wilson, North Carolina expansion when over 50 employees moved into a new 30,000 square foot building.
Over 65 new jobs are expected to be created in Wilson as a result of the $10 million expansion. The positions will be filled by pharmaceutical scientists and analytical chemists and will bring the total of employees at the site to almost 480.
“The new laboratories present an excellent workplace and opportunity for top scientists to help us continue to growth in the U.S.,” said Bernhard Hampl, president and chief executive officer of Sandoz. “The new products developed at the site will be the basis for the future growth of the Wilson site.”
Pfizer, Taisho sign letter of intent over schizophrenia drug candidate
TOKYO and NEW YORK Taisho Pharmaceuticals and Pfizer have concluded on a letter of intent with regard to Taisho’s new drug candidate for schizophrenia, TS-032.
The drug is currently in the pre-clinical stage and the letter of intent relates to a proposed license agreement regarding rights for development and commercialization.
Through the agreement, Taisho will grant exclusive development and commercialization rights outside Japan for the drug to Pfizer. Once the agreement is signed, Taisho will receive an initial payment of $22 million as well as milestone and royalties linked to the development and sales of the drug.