PHARMACY

Reagan-Udall faces suspicion, scrutiny

BY Drew Buono

WASHINGTON The Reagan-Udall Foundation, which was created to help the Food and Drug Administration deal with increasingly complex science, spur innovation and improve safety has been under a lot of scrutiny, and this is even before the first board meeting takes place, according to The Star-Ledger.

The foundation’s stated goal is to conduct research to help the agency modernize drug, medical, veterinary, food and cosmetic product development, accelerate innovation and enhance product safety. Many people in the government, however, believe that this won’t take place without pharmaceutical industries having a say in the foundation’s final decisions.

Recently, one of the appointed board members faced his own criticism for attempting to block criticism about the heart risks of the diabetes drug Avandia, because he previously worked for its manufacturer, GlaxoSmithKline. This, along with the foundation rule that they must get their funding privately has put the foundation under the microscope for suspicious activity.

Mark McClellan, a former FDA commissioner under President Bush insisted that the foundation will not be making FDA policy, influencing regulatory decisions or seeking to benefit one interest over another. He said the purpose will be to support the FDA by “focusing on science and doing the right thing for patients.”

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Gardasil vaccine recipients report extreme pain, fainting

BY Drew Buono

MELBOURNE CITY, Australia New reports have shown that the Gardasil vaccine, which is given in three doses to females between the ages of 9 and 26 to prevent against a sexually transmitted virus that causes cervical and vaginal cancer, has been causing extreme pain and also has made girls faints, according to reports from Australia.

Officials at Merck, which makes the vaccine, attributes it partly to the virus-like particles in the shot. Studies showed more reports of pain from Gardasil than from placebo shots, and patients reported more pain when given shots with more of the particles. While many say the pain is short-lived, some say driving or sleeping on the injected arm is uncomfortable for up to a day after.

U.S. health officials have noticed a rise in reports of vaccine-associated fainting in girls. From 2002-04 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on to the market in 2006.

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Pfizer, Taisho announce partnership to develop schizophrenia treatment

BY Drew Buono

NEW YORK & TOKYO Pfizer and Taisho Pharmaceuticals have signed a definitive agreement to replace their letter of intent for the worldwide (excluding Japan) collaboration to research, develop and commercialize TS-032, a drug candidate for schizophrenia, as well as other central nervous system disorders that is currently in preclinical development.

Under the agreement, Taisho will receive an initial payment of $22 million from Pfizer. The company will also receive milestone payments related to progress of development, as well as royalties and milestone payments tied to sales if TS-032 is approved by regulatory authorities and launched.

“We are pleased to partner with Taisho in this important area of research. Schizophrenia is among the most chronic and disabling of mental health conditions and there still remains a significant need for novel treatment advances with improved efficacy and fewer side effects,” said Martin Mackay, president of Pfizer Global Research and Development. “Pfizer has a long-standing strength in developing and commercializing medications for the treatment of psychiatric illnesses, including Zoloft, Xanax and Geodon. This agreement highlights our commitment to pursue opportunities that align strategically with our key development priorities and strengthen our pipeline.”

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