Orphan Medical Xyrem safety data
Safety data on Orphan Medical's Xyrem (sodium oxybate) in respiratory-compromised patients may be collected post-approval if FDA accepts submission of data on that patient population from an earlier trial, Orphan says. A July 2 "approvable" letter for the narcolepsy treatment indicated that a study would be required before approval. Orphan plans to file the additional data in mid-November and expects a six-month review
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.