Amivas, LLC
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Latest From Amivas, LLC
BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
BeiGene’s Brukinsa Among Five Orphan Drugs Awaiting EU Approval Verdict
Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.
Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune
Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.
Alzheimer’s Drug & Dermatitis JAK inhibitor Among New EU Filings
Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.
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