BAYER, BAXTER, RPR, ALPHA THERAPEUTIC OFFER $100,000 PER HEMOPHILIA CLAIMANT to a class of approximately 6,000 plaintiffs who allege that the companies negligently sold them blood-clotting products, Factor VIII and/or Factor IX, derived from HIV-tainted human blood plasma. The settlement offer is subject to a $640 mil. cap, including administrative costs and attorneys' fees. The class action dates to 1993.
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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.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
