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The EMA has put Boehringer Ingelheim's hepatitis C drug candidate faldaprevir on a speedy review pathway based on studies involving 3,300 patients. Read More
The FDA has extended its review of Mallinckrodt’s NDA for its investigational painkiller Xartemis XR by 90 days, saying it needs more time to review the drug’s proposed labeling. Read More
The FDA’s Office of New Drugs has notified Amarin that it is refusing to review the company’s appeal of the agency’s decision to rescind the SPA for the drugmaker’s ANCHOR study of its heart drug Vascepa. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee strongly urged approval of BioMarin’s orphan drug Vimizim to treat the rare disease Mucopolysaccharidosis Type IVA, overriding agency concerns of limited supportive data. Read More
Sanofi has decided to stop pursuing regulatory filing for its blood cancer drug fedratinib after new safety concerns arose from several clinical trials. Read More
The FDA has granted “regular” approval for Pfizer’s lung cancer drug Xalkori after conditionally approving it in August 2011 under the agency’s accelerated approval program. Read More
The European Medicines Agency will accept premarket applications with limited data for antibiotics that target unmet needs, according to an amended guideline on developing antibacterial drugs for multidrug-resistant infections. Read More
An effort to foster better communication between the FDA’s drug and device centers is starting to pay off, with fewer requests for duplicate data on companion diagnostic submissions. Read More
Sponsors of medical device clinical trials should avoid recruiting and putting at risk an unnecessarily large number of patients, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More