Sanofi-Aventis intends to resubmit its NDA for Zimulti (rimonabant) pending clarification of FDA's questions regarding its obesity claim. The firm announced it was withdrawing the application June 29, roughly two weeks after the agency's Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted against approval of the cannabinoid-1 receptor antagonist for weight loss
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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.’
While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
