Auxilium Pharmaceuticals, Inc. and FCB I LLC announced today that they filed a lawsuit against Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.; and Watson Pharma, Inc. (collectively, "Watson") for infringement of FCB's ten patents listed in the U.S. Food and Drug Administration's ("FDA's") Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book") as covering Testim 1% testosterone gel. The lawsuit was filed in the United States District Court for the District of New Jersey on May 23, 2012.
A panel of federal cancer experts has unanimously voted to grant accelerated approval to Seattle Genetics' (Nasdaq:SGEN) innovative chemotherapy drug to treat patients with recurring Hodgkin's disease, a cancer of the white blood cells.
All 10 members of the Food and Drug Administration's oncology drug panel voted in favor of approving the drug based on a single study in about 100 patients. Regular approval normally requires two trials. The FDA is not required to follow the group's advice, though it usually does.
NEW YORK (AP) — Regeneron Pharmaceuticals Inc. and Sanofi said a clinical trial showed their drug candidate sarilumab reduced symptoms of moderate to severe rheumatoid arthritis.
The companies said late Tuesday that they are discussing the doses of the drug that will be tested in a late-stage clinical trial. In a mid-stage trial, the companies said patients who were treated with sarilumab and methotrexate improved more than patients who were treated with methotrexate and a placebo.