FDA’s Benlysta Approval: A Lesson In Overcoming Unvalidated Endpoints
A novel composite primary endpoint created by Human Genome Sciences with FDA’s blessing helped Benlysta (belimumab) obtain approval for lupus – one of contemporary drug development’s most challenging indications – despite the absence of a standard disease outcome measure.
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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.’
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Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.
The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.
US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.