nav-left cat-right
cat-right

Genentech to Appeal to F.D.A. for Breast Cancer Dr...

Genentech this week will step up its efforts to keep the drug Avastin available as a treatment for breast cancer, urging the Food and Drug Administration to give it one more chance to prove the medicine works. At a hearing on Tuesday and Wednesday in suburban Washington, Genentech will ask the F.D.A. to reconsider its proposal last December to revoke the approval of Avastin for breast cancer on the grounds that new studies...

Experimental Type 1 diabetes vaccine fails during ...

The quest for a vaccine to stop Type 1 diabetes in its tracks has hit a roadblock. An experimental drug failed in the second step of a three-phase trial on 145 American and Canadian patients who had just been diagnosed with the disease. The vaccine is based on an enzyme that is targeted by a diabetes patient’s immune system. Researchers hoped the vaccine would train the immune system to not attack the enzyme...

Kidney improvement sustained by Abbott drug-study

NEW YORK, June 24 (Reuters) – Diabetics with moderate to severe chronic kidney disease showed significant and sustained improvement in kidney function through 52 weeks of treatment with a novel drug being developed by Abbott Laboratories (ABT.N), according to data from a midstage clinical trial. The oral drug, bardoxolone methyl, is the first medicine to demonstrate improvement in kidney function in patients with the...

Pfizer’s Remoxy Fails to Win FDA Approval

WASHINGTON — The latest attempt at an abuse-resistant formulation of oxycodone (Remoxy) failed to win approval from the FDA, according to a statement from Pfizer. Late Thursday, the company said it had received a complete response letter from the FDA, which described the reasons for the FDA’s decision. The FDA had turned down an earlier version of the drug in 2008, but Pfizer’s King Pharmaceuticals...

Pfizer, Acura Say FDA Clears Painkiller Oxecta

Pfizer Inc. and Acura Pharmaceuticals Inc. said Monday the Food and Drug Administration approved a powerful painkiller that is designed to be harder to abuse. The FDA cleared marketing of Oxecta as an immediate-release treatment for moderate to severe pain. The drug is designed to discourage common methods of abuse like crushing or dissolving, and it contains a compound that irritates the nose if it is snorted. Shares of...

UPDATE 1-Pfizer stop-smoking pill raises heart ris...

WASHINGTON, June 16 (Reuters) – Pfizer Inc’s (PFE.N) stop-smoking drug Chantix can lead to a small increase in cardiovascular problems such as heart attacks for patients who already have cardiovascular disease, U.S. drug regulators said on Thursday. The Food and Drug Administration is changing the label for Chantix after reviewing the results of a clinical trial. An independent randomized trial of 700 smokers with...
Page 13 of 34« First...1112131415...2030...Last »