Gilead Sciences Inc.'s four-drug, single-tablet HIV drug Quad got its much-anticipated approval Monday, and the drug is expected to shore up the firm's top-selling HIV franchise, which brought in $7.05 billion in revenue in 2011 but faces patent expiries starting in 2018. Read More
The FDA surprised Genzyme Corp., a Sanofi company, with a refuse to file letter for its supplemental biologics license application (sBLA) for Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis (MS). Read More
Calling it "one of the most significant unresolved legal questions currently affecting the pharmaceutical industry," Merck & Co. Inc. hit the pay-for-delay ball into the Supreme Court, asking the court to, once and for all, determine whether the reverse settlements violate federal antitrust laws. Read More
Roche Group unit Genentech Inc. moved its HER2-positive metastatic breast cancer (mBC) candidate T-DM1 (trastuzumab emtansine) to the regulators, submitting a biologics license application (BLA) for the drug to the FDA and requesting priority review. Read More
• Meda AB, of Göteborg, Sweden, said the European Commission has granted marketing authorization for Zyclara (imiquimod 3.75% cream) for the treatment of actinic keratosis in the EU. Read More
• Debiopharm Group, of Lausanne, Switzerland, treated its first patient in an open-label, Phase III trial of triptorelin pamoate 22.5 mg 6-month formulation in children with central precocious puberty. The study will enroll 44 children from the U.S., Chile and Mexico, with a primary objective of evaluating safety and efficacy in reducing luteinizing hormone to prepubertal levels after six months. Read More
• Merz Inc., of Greensboro, N.C., said it acquired Cuvposa (glycopyrrolate) oral solution, an acetylcholine receptor inhibitor, for pediatric chronic severe drooling associated with neurologic conditions such as cerebral palsy. Financial terms were not disclosed. Read More
• Daiichi Sankyo Co. Ltd., of Tokyo, and Eli Lilly and Co., of Indianapolis, reported data from the TRILOGY ACS study, a Phase III trial comparing prasugrel plus aspirin to Plavix (clopidogrel, Sanofi SA and Bristol-Myers Squibb Co.) plus aspirin in patients with unstable angina or non-ST elevation myocardial infarction, who were managed medically without an artery-opening procedure. Read More
