07:00 , Apr 15, 2013 |  BC Week In Review  |  Company News

Interneuron, Wyeth-Ayerst metabolic news

Wyeth-Ayerst named the members of its cardiovascular assessment panel that will advise the company on medical and scientific issues relating to the possible heart valve defects associated with Wyeth-Ayerst's Pondimin fenfluramine and IPIC's Redux dexfenfluramine...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Clinical News

Interneuron, Wyeth-Ayerst regulatory update

Wyeth-Ayerst notified health care providers that it is working with the FDA to develop label warnings about potential side effects of combination use of fenfluramine and phentermine to treat obesity. The revisions will include a...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Company News

The Liposome, Wyeth-Ayerst International Inc. deal

The partners expanded their distribution agreement for LIPO's Abelcet liposomal amphotericin B. Wyeth-Ayerst will market the drug in Denmark as a first-line treatment of systemic Candida (fungal) infections, in Finland, Iceland and Sweden as a...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Company News

Interneuron metabolic, neurological news

A class action lawsuit was filed in the U.S. District Court for the District of Massachusetts on behalf of all purchasers of IPIC common stock between March 1 and Sept. 15, 1997. The complaint alleges...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Company News

Interneuron, Les Laboratoires Servier, Wyeth-Ayerst sales and marketing update

Wyeth-Ayerst withdrew its Pondimin fenfluramine and IPIC's Redux dexfenfluramine from the market in the U.S. after the FDA released new data regarding possible heart valve defects associated with use of the drugs (see BioCentury Extra,...
08:00 , Mar 3, 2008 |  BioCentury  |  Politics, Policy & Law

Supreme preemption

The U.S. Supreme Court has taken a great interest in suits that pit FDA's authority against state tort laws when a patient has allegedly been harmed by an FDA-approved product. The court ruled in favor...
08:00 , Feb 25, 2008 |  BioCentury  |  Regulation

Rotavirus showdown

An FDA advisory panel's endorsement last week of Rotarix , developed by Avant Immunotherapeutics Inc. and GlaxoSmithKline plc , sets the stage for a rivalry with Merck & Co. Inc. , which has had the...
07:00 , Aug 14, 2006 |  BC Week In Review  |  Company News

Tranzyme management update

Tranzyme Pharma Inc. , Research Triangle Park, N.C.   Business: Gastrointestinal, Genomics, Proteomics   Hired: Eric Nelson as VP of business development and licensing, formerly assistant VP of technology licensing of Wyeth's Wyeth-Ayerst Laboratories Inc....
08:00 , Dec 5, 2005 |  BC Week In Review  |  Company News

Epitan Ltd management update

Epitan Ltd . (ASX:EPT), Melbourne, Australia   Business: Dermatology   Resigned: Iain Kirkwood as CEO; he will be replaced by Philippe Wolgen, formerly manager of a pharmaceutical business unit at MOG Group   Hired: Hank...
08:00 , Dec 6, 2004 |  BioCentury  |  Product Development

Accelerated approval history

Accelerated approval history Studies reviewed Product Indication Approved Company (total patients) (A) Arimidex anastrozole Adjuvant treatment for hormone receptor-positive early breast cancer 9/5/02 AstraZeneca 1 (9,366) Bexxar tositumomab Non-Hodgkin's lymphoma (NHL) 6/27/03 Corixa 1 (60)...