PHARMACY

BIO’s Greenwood commemorates 25th anniversary of Orphan Drug Act

BY Drew Buono

WASHINGTON Biotechnology Industry Organization president and chief executive officer Jim Greenwood issued the following statement last week to commemorate the 25th anniversary of the Orphan Drug Act: “This landmark law helped lead to the development of new drugs and biologics for rare and frequently untreated diseases by granting seven years of market exclusivity to the developer of a new therapy for a disease which affects less than 200,000 people in the U.S.”

He added that, “the law has led to a vast increase in the number of therapies available to the more than 25 million Americans living with one of the 7,000 recognized rare diseases and significantly contributed to the growth of the biotechnology industry.

The biotech industry has historically taken financial risks to develop therapies and cures to serve small patient populations suffering from rare, devastating diseases. The Orphan Drug Act established some necessary protection to attract the investment required to research and develop these breakthrough technologies.”

In the ten years before the Orphan Drug Act was signed into law, only ten new drugs were developed for rare diseases. In the past 25 years, the Food and Drug Administration has approved more than 300 drugs to treat orphan diseases.”

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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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