Company news: Genzyme, Genentech and moreThe FDA has sent a Refuse to File letter to Genzyme over its experimental MS drug Lemtrada (alemtuzumab). The Sanofi subsidiary said in a statement that the FDA has not asked for new studies, but wants the company to make it easier to navigate supporting data. The company said it expects to be able to quickly resubmit its application. The letter comes days after it was reported that Genzyme was changing the distribution of its sister drug Campath, which is indicated for leukemia.
The Centers for Medicare and Medicaid Services issued a one-year reprieve from implementing ICD-10 codes. The change means hospitals will not have to have the new procedures and diagnosis labels in place until October 1, 2014, instead of October 1, 2013. Information Week reported that medical professionals needed a delay, and cited a study that found only 30% of health plans said they would be able to meet at 2013 target date, compared to 61% who said they would definitely be ready by 2014.
Genentech announced Sunday that Phase III trials of breast cancer drug trastuzumab emtansine (T-DM1) significantly extended the lives of patients with HER2-positive metastic breast cancer, compared to patients taking a mix of lapatinib and Xeloda (capecitabine). The study was among patients who had previously undergone Herceptin (trastuzumab) and taxane therapy. Genentech said it has already submitted a biologics license application with the FDA and will soon be filing an authorization application with European regulators.
The Annals of Internal Medicine now has an iPad app. The free app includes current issues and articles, specialty topic collections, videos and audio summaries, CME quizzes and the ability to search the archives.