Deputy Commissioner for Policy Amit Sachdev formally resigns from the agency, Acting Commissioner Lester Crawford announces in an internal memorandum. Crawford cited Sachdev's work with Congress on FDA oversight, his contributions to expanding the agency's access to more resources for its various centers and leadership in speeding up review of medicines to treat HIV/AIDS under the White House's global AIDS initiative. Sachdev, whose last day was March 25, has not disclosed his future plans...
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
