WASHINGTON, May 8- A U.S. House of Representatives panel advanced a bill on Wednesday on how the federal government should track prescription drugs as they move through the distribution chain, over the objections of some Democrats who said the proposal did not go far enough to ensure safety.
After approvals last year from the FDA for 39 novel medicines- a record only beaten in 1996- the healthy pace has continued into 2013.. And drugmakers are getting further help from a new FDA program to accelerate life-saving therapies designated as a "breakthrough," opening to door to earlier approval based on quicker studies, where clinical data is compelling.
NEW YORK-- Shares of Alexza Pharmaceuticals Inc. jumped Wednesday after the company said Teva Pharmaceutical Industries Ltd., one of the world's largest drug companies, will market is agitation drug Adasuve in the U.S.
Shares of Jazz Pharmaceuticals PLC slid Wednesday morning, a day after the Irish drugmaker said in a regulatory filing that the Food and Drug Administration could approve a competitor's generic version of its top-seller, narcolepsy treatment Xyrem.
NEW YORK-- Shares of Santarus Inc. jumped Tuesday after the biopharmaceutical company posted strong first-quarter results and raised its forecast for the full year. THE SPARK: Santarus reported its quarterly results after the market closed on Monday.
*Bankers expect steady flow of $1 bln to $5 bln pharma deals. The stock valuations of companies like Regeneron Pharmaceuticals Inc, Gilead Sciences Inc, Celgene Corp and Biogen Idec Inc have skyrocketed in the past year or two alone, making it difficult for large pharmaceutical companies to buy them and leaving a trail of dead deals.
LEXINGTON, Mass.-- Cubist Pharmaceuticals Inc. said Tuesday that the Food and Drug Administration has given fast-track status to an experimental antibiotic regimen as a treatment for three types of infections. In February, the FDA granted fast-track status for the drug regimen as a treatment for complicated intra-abdominal infections.
May 7- Cubist Pharmaceuticals Inc:. *FDA grants fast track designation for cubist's late-stage antibiotic. *Says expects to initiate a phase 3 vabp program for ceftolozane/tazobactam by.
*FDA clears Masimo rainbow acoustic Monitoring (TM) sensor for use on.
May 3- The U.S. Food and Drug Administration approved a Merck& Co. cholesterol lowering pill that combines a generic version of Pfizer Inc's Lipitor with its own Zetia, Merck said on Friday. Vytorin, which had sales of $1.75 billion in 2012, is currently undergoing a long-term trial to prove that it can reduce heart attacks and strokes better than Zocor alone.