The Vice President’s cancer “moonshot” is a great opportunity for biopharma companies to engage in a process that should remind policymakers and the public of the promise of biomedical innovation at a time when the industry’s pricing and financial engineering activities are under scrutiny on Capitol Hill. The selection of the “blue ribbon” panel puts those two images in stark contrast.
Whatever else the Vice President’s cancer “moonshot” initiative becomes, it is a welcome opportunity for innovative biopharma companies to put their best foot forward.
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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 International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease
