AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.

Stock of Cambridge, Mass.-Based Genzyme Tumbles 8 Percent on FDA Delay.

The Boston Globe (Boston, MA)

| December 28, 2000 | COPYRIGHT 2000 The Boston Globe. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Byline: Naomi Aoki

Dec. 28--Shares of Genzyme Corp. fell as much as 8 percent yesterday, a day after the company said the Food and Drug Administration had asked for additional information on the company's treatment for Fabry disease.

The delay of a decision on approval of the drug Fabrazyme sparked yet another round of speculation among investors about whether Genzyme could beat Transkaryotic Therapies Inc. in the race to become the sole provider of a breakthrough treatment for the rare genetic disorder.

FDA rules require that only one drug be approved to treat a rare disease such as Fabry, which affects only a few thousand people worldwide. The "orphan drug" act gives a company 10 years to sell its drug unhindered by competition in exchange for being the first to develop a drug to treat a rare disease.

The rule seems to turn the race for approval into a winner-take-all proposition for one of the Cambridge companies. Both firms submitted their applications to the FDA in June.

Related articles from newspapers, magazines, journals, and more
FDA Approves Visx Inc. Plan to Use Laser Equipment for Astigmatism.(Originated...
Newspaper article from: Knight Ridder/Tribune Business News Rosenberg, Ronald January 16, 1997 700+ words
...astigmatism. Visx was seeking FDA approval to treat patients 18...Visx researchers told the FDA panel its laser corrected astigmatism...considered 20/20. The expected FDA approval will still benefit...the World Wide Web site of The Boston Globe, at http://www.boston...
Boston Firms Applaud Bill to Streamline FDA Drug, Device Approvals.(Originated...
Newspaper article from: Knight Ridder/Tribune Business News Rosenberg, Ronald November 11, 1997 700+ words
...the biotech industry and the FDA, said Charles C. Cabot, chief...would do what you thought the FDA wanted you to do and only find...expediting review times, the FDA has taken far-reaching steps...Cambridge. ----- Visit The Boston Globe on the World Wide Web at http...
Cambridge, Mass.-Based Genzyme Receives FDA Approval for Seprafilm.(Originated...
Newspaper article from: Knight Ridder/Tribune Business News Rosenberg, Ronald August 14, 1996 700+ words
...a limited go-ahead from an FDA advisory panel last March...The panel, whose views the FDA often follows in making its...labeling approved yesterday by the FDA is much broader than the panel...the World Wide Web site of The Boston Globe. Point your browser to http...
Boston's Genzyme Receives FDA Approval to Produce New Drug.(Originated from The...
Newspaper article from: Knight Ridder/Tribune Business News Rosenberg, Ronald October 25, 1996 700+ words
...evaluation in preparation for FDA approval. Construction began...before Genzyme received FDA approval for Cerezyme -- and...Framingham plant, which is FDA approved. Ceredase production...the World Wide Web site of The Boston Globe. Point your browser to http...
Rival Firms Celebrate FDA Approval of Laser Eye Surgery Treatment.(Originated...
Newspaper article from: Knight Ridder/Tribune Business News Bray, Hiawatha April 26, 1997 700+ words
...consumers are concerned." The FDA approved Summit lasers for use...nearsightedness alone, and the FDA decision opens up a substantial...investigation about confidential FDA documents about Visx Inc. that...ON THE INTERNET: Visit The Boston Globe on the World Wide Web at http...
Genzyme Corp. Wins FDA Panel Approval to Use Seprafilm Product.(Originated from...
Newspaper article from: Knight Ridder/Tribune Business News Rosenberg, Ronald March 26, 1996 700+ words
...got what they wanted from the FDA group. The group's recommendation will now go to the FDA for final approval. "We are...surgical product undergoing FDA review called Sepracoat, a...ON THE INTERNET: Visit The Boston Globe Web edition on the World Wide...
Boston Biomedica Shares Jump on News of FDA Approval of Products.(Originated...
Newspaper article from: Knight Ridder/Tribune Business News Ackerman, Jerry September 13, 1997 700+ words
...The company announced its FDA approvals after the close of...five products approved by the FDA in August are used with hepatitis...diseases. ----- Visit The Boston Globe on the World Wide Web at http...c) 1997, The Boston Globe. Distributed by Knight-Ridder...
Massachusetts Biotech, Medical Firms Hail Speeding Up FDA Reviews.(Originated...
Newspaper article from: Knight Ridder/Tribune Business News Zitner, Aaron October 8, 1997 700+ words
...biotechnology firms, the bill would force the FDA to grant "fast track" reviews to drugs that...independent testing firms, rather than by the FDA itself. This will allow the overburdened FDA staff to focus on the most complex devices that...
For more facts and information, see all results
©2009 Gale, a part of Cengage Learning. All rights reserved.
About us | FAQs | Contact us | Privacy policy | Terms and conditions
Other Gale sites: Encyclopedia.com | HighBeam Research | Acquire Content | Books & Authors | Goliath | MovieRetriever | Smart QandA