FDA advisers recommend approving anticlotting drug

The Burrill Report submits: Merck (MRK) said it was discontinuing a study of its experimental anticlotting drug vorapaxar in patients with acute coronary syndrome after a data safety monitoring board reviewed safety and efficacy data and recommended the study be halted.

WASHINGTON (AP) -- A new anticlotting drug that had been seen as a blockbuster comes under scrutiny by a panel of outside advisers to the Food and Drug Administration Thursday, two days after a negative review by FDA staff....

Zacks.com submits: Ireland-based health care product maker Covidien plc (COV) has backed the U.S. Food and Drug Administration's ((FDA)) recent labeling changes for Gadolinium-based contrast agents (GBCAs) for patients with renal diseases. GBCAs, which contain the chemical element gadolinium, are injectable drugs that are frequently used in magnetic resonance imaging ((MRI)) scans.

The Food and Drug Administration says it has approved the anticlotting drug Eliquis, developed by Bristol-Myers Squibb and Pfizer. It's a potential blockbuster drug in a new category of medicines.

An advisory panel for the US Food and Drug Administration voted Tuesday to recommend a new drug treatment for lupus which if approved would be the first treatment for the disease in more than 50 years.An FDA spokeswoman said the committee voted 13-2 in favor of a drug called Benlysta, an experimental therapy developed by pharmaceutical companies Human Genome Sciences and GlaxoSmithKline.The full FDA must next consider whether to approve the drug for the market. Typically the agency follows the recommendations of the advisory panel.

The Burrill Report submits: Shares of Cambridge, Massachusetts-based Curis (CRIS) fell nearly 50 percent on news that its experimental drug in combination with Avastin and chemotherapy failed in a mid-stage trial in metastatic colorectal cancer.

18 THUMBS UP: FDA advisers vote 18-4 to recommend the agency approve sales of lorcaserin, which could be the country's first new prescription diet drug in over a decade.

The Food and Drug Administration released a series of reports Friday on the controversial diabetes drug Avandia. The reports summarize all that is known about the drug's safety, and on balance, they paint a negative picture: The drug increases the risk of heart attacks, strokes and death. The documents come in advance of a meeting next week where FDA advisers will vote on whether the drug should stay on the market. Melissa Block talks with Joanne Silberner about the reports.