Merck is bolstering its pipeline through acquisitions and licensing deals, many in biotech. The drug maker evaluates 6,000 opportunities per year and signed 44 transactions in 2005.
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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.’
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
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.
