Monthly Archives: July 2010

Weight-Loss Drug Qnexa Loses in FDA Committee Ruling

Vivus’ Qnexa may help in weight loss, but it also now risks losing its place in the market following FDA’s Advisory Committee’s ruling July 15. The panel of medical experts did not question the effectiveness of the drug, but rather voiced its concerns over safety of the medication. The FDA’s Endocrinologic and Metabolic Drugs Advisory […]
Posted in FDA, Safety | Tagged , , , , , , , | 3 Comments

Judgment Day for Avandia

Judgment Day has finally arrived for GSK’s Avandia. FDA’s Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees met July 13 and 14 to finally recommend, after months of deck-stacking against GSK, that the drug be severely restricted, if not outright pulled from the market. In the vote, 12 of 33 panelists […]
Posted in FDA, Regulatory | Tagged , , , , , , , | Leave a comment

Avandia on Trial

The mid-July FDA advisory committee meeting to decide the fate of GlaxoSmithKline’s Avandia (rosiglitazone) is widely viewed as a test case of how the agency’s new leadership will address controversial drugs with serious risks but confusing data. A request that GSK yank its diabetes blockbuster—three years after first being associated with an increased risk of […]
Posted in Legal | Tagged , , , , , , , | Leave a comment

The Bizarre European Political Bazaar

Pharm Exec Europe‘s Brussels correspondent Reflector is exasperated by some of the European Union’s more unusual institutional arrangements. A senior Spanish diplomat told Reflector recently that, on the face of it, the European Union is a crazy set-up. He was talking about some of its bizarre institutional arrangements — such as a Commission composed of […]
Posted in Strategy | Leave a comment

Merck to Close Eight Plants

Image by Getty Images via @daylife Over the next two years, Merck will shut down eight manufacturing plants, as well as eight research sites, as part of the ongoing Schering-Plough merger process. The company said in a statement that the various site exits will help “create a flexible R&D organization.” Taking a page out of […]
Posted in Strategy | Tagged , , , , , , , | 3 Comments
  • Categories

  • Meta