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Early FDA approval for Portola

South San Francisco-based Portola Pharmaceuticals ($PTLA) has nabbed boasting rights to the FDA’s new breakthrough drug designation for andexanet alfa (PRT4445), its Factor Xa inhibitor antidote designed to hit the brake on blood thinners when they turn dangerous. And the biotech says that the BTD helps set the stage for its campaign to win an accelerated approval while pursuing a 2014 launch of a registration...

FDA says new cholesterol drugs may not need outcom...

Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower “bad” cholesterol, and may not need to show that they reduce the risk of heart attack and stroke, the Food and Drug Administration said on Thursday. The statement eased industry concerns that the agency would require more onerous “outcome” studies before approving the drugs,...

FDA Clears Abbott’s Confirmatory Chagas Disease As...

FDA approved Abbott’s in vitro enzyme strip assay for Chagas disease. The Abbott ESA Chagastest detects antibodies to the causative pathogen Trypanosoma cruzi in serum or plasma samples. It is indicated for use as an additional, more specific test on human samples that have been found to be repeatedly reactive using a licensed screening test. The T. cruzi parasite is transmitted through contact with the feces of an...

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...

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...

New Drug Effectively Treats Hepatitis C

WEDNESDAY, June 22 (HealthDay News) — The recently approved drug Incivek, combined with two standard drugs, is highly effective at treating hepatitis C, a notoriously difficult-to-manage liver disease, two new studies show. The drug works not only in patients just starting treatment, but in those who failed earlier treatment, the research found. The hepatitis C virus can lurk in the body for years, causing liver...
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