PHARMACY

FDA releases guidance to speed up device review times

BY Drew Buono

WASHINGTON A new review process by the Food and Drug Administration aimed at speeding the review times of medical device application is being outlined in a guidance advising applicants of when and how to contact the agency during a review cycle.

The new process is part of several changes under the reauthorized medical device user fee program. The process will apply to pre-market notification submissions, original pre-market approval applications, pre-market approval supplements, original biologics license applications, and biologics license applications supplements.

By using an interactive review system, the interaction between the FDA and applicants will increase, including the exchange of scientific and regulatory information, according to the guidance. The guidance is now available at the FDA’s website.

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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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