The Sage Group: Managing director of newly-formed biotech consulting firm is Wayne Pambianchi, formerly an exec of Johnson & Johnson and co-founder of the Immune Response Corp., Cortex Pharmaceuticals and Odyssey Therapeutics. Co-founders at Sage Group include Gordon Ramseier, former president and CEO of Dura Pharmaceuticals and OncoTherapeutics; Douglas Hulse, former president and CEO of i-STAT Corp. and VP-business development at Enzon; Daniel Tripodi, PhD, formerly an exec at Johnson & Johnson, Becton-Dickinson and New England Nuclear; and Richard Power, former CEO of Pharmatech and Xenon Vision...
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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.’
Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.
Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.
Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.
