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Senior European Medicines Agency (EMA) officials are cautioning their peers that when it comes to making regulatory decisions, high levels of risk aversion may do more harm than good. Read More
FDA advisers overwhelmingly voted Thursday to recommend approval of Vanda’s sleep drug tasimelteon for the visually impaired despite some concern over a clinical trial’s primary endpoint. Read More
The FDA has delayed Sarepta Therapeutics’ NDA submission for its Duchenne muscular dystrophy (DMD) drug because of a failure in trials of a similar drug. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has asked Janssen for more information on its multiple myeloma treatment Velcade before an appraisal committee can make final recommendations on its use in patients untreatable with high-dose chemotherapy and haematopoietic stem cell transplant. Read More
Sanofi’s bid to expand the indication for its biologic Lemtrada to treat relapsing multiple sclerosis (MS) faces tough scrutiny by FDA advisors as agency reviewers say data supporting the application point to “serious and potentially fatal safety issues.” Read More