The European Medicines Agency-Food And Drug Administration-Theratechnologies Inc

Theratechnologies sinks on HIV drug setback

(Reuters) - Theratechnologies Inc shares plummeted more than 60 percent on Friday after the Canadian drugmaker said its European partner, Ferrer Internacional SA, was withdrawing a marketing application for its lead drug for HIV patients. The Spanish company's decision to pull the European Medicines Agency application for tesamorelin, used to reduce excess abdominal fat in HIV-infected patients with lipodystrophy, was made after a health committee raised safety concerns. The injectible drug is already approved by the U.S. Food And Drug Administration, according to the company's website. ... read more..

source:http://yhoo.it/Lpt4Lm

Food And Drug Administration-Antiretroviral Drugs-Health Regulators-Clinical Trial

Merck gets approval for wider use of HIV drug

(Reuters) - U.S. health regulators have approved an expanded label for Merck & Co's treatment for HIV for use with other antiretroviral drugs in children and adolescents. The safety and effectiveness of the drug was evaluated in a clinical trial of 96 children and adolescents of ages 2-18 years with HIV-1 infection, the U.S. Food And Drug Administration said in a statement. The drug, Isentress, was first approved for use in adult patients in October 2007. (Reporting by Shailesh Kuber in Bangalore; Editing by Don Sebastian) read more..

source:http://yhoo.it/vqE6sK

Food And Drug Administration-Generic Drugmakers-Health Regulators-Glaxosmithkline

FDA says Merck's HIV drug gets generic threat

(Reuters) - Health regulators said they have received applications from generic drugmakers to make copycat versions of Merck & Co's HIV drug Isentress, GlaxoSmithKline's HIV drug Epivir and Bayer AG's birth control pill Beyaz. However, the U.S. Food and Drug Administration did not disclose the names of the generic drug applicants. Isentress was first approved in 2007 for use in adult patients. Last month, the FDA expanded the label on the drug for use in children and adolescents. Merck shares were trading almost flat at $38.58 on Tuesday on the New York Stock Exchange. ... read more..

source:http://yhoo.it/zwPhxS