Ranbaxy Laboratories is back in the generic Lipitor saddle again. Three months after stopping production of the cholesterol fighter and recalling almost a half-million bottles, the Indian drugmaker says it is restarting production for the U.S. market.
After being turned down by the European Committee for Medicinal Products for Human Use (CHMP) in October, Vivus asked that the drug, called Qsiva there, get a second look. The regulators are not ready to approve it now and they will not even consider approving it in the future unless the company does a new trial on its cardiac dangers.
A recall of generic Lipitor had already devastated Ranbaxy Laboratories' market share and entangled it in litigation. Now it has sparked a war of words between the Indian drugmaker and lawyers for consumers who say they were injured by products believed to have been tainted by glass particles.
Gilead Sciences is voluntarily recalling one lot of its AIDS drug Vestide. The company said in a notice that some particles were found in vials during packaging and that it has undertaken an investigation to figure out what led to the problem.
More drugmakers are joining up with anti-doping authorities to nip abuse in the bud, The New York Times reports. GlaxoSmithKline--which sponsored the testing lab for the 2012 Olympics--and Roche have both shared proprietary information with the World Anti-Doping Agency, including data on drugs still in development.
Fido and Fluffy are getting their paws on more of their humans' prescription medicines these days.
For the past few weeks Idenix has been methodically moving away from its once-promising hepatitis C drugs, put on clinical hold by a jittery FDA in the wake of a catastrophic trial of a somewhat similar drug at Bristol-Myers Squibb.
The closed Novartis consumer products plant in Lincoln, NE, that has besmirched the drug giant's reputation and frustrated CEO Joseph Jimenez has bitten the company again.
France's drug regulators last year faced scathing criticism for dragging their feet when it came to the dangers of off-label use of diabetes drug Mediator. Now faced with consumer fears over deaths tied to off-label use of Bayer acne drug, Diane-35, they are acting with dispatch.
The European Medicines Agency is launching its own review of contraceptive safety. At the request of France, which zeroed in on the risk of blood clots with third- and fourth-generation birth control pills, EMA says it will also sift the data.