NCCAM Prepares For Intramural Program, More Selective Research Funding

NIH's National Center for Complementary & Alternative Medicine will establish its Office of Intramural Research shortly after naming a director to head the new program, an action anticipated by January.

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EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
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Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.