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American Medical Systems Holdings, Inc

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Hits, Misses & Key Firsts For EMA’s PRIME Scheme

The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.

Europe Research & Development

Four Orphan Drugs Get EU Approval Recommendation

The European Medicines Agency had a busy time at its meeting last week. It gave the green light to 11 products, four of which are for rare diseases including ANCA-associated vasculitis, and to a range of treatments for conditions as diverse as non-small cell lung cancer, smallpox, migraine, COPD, COVID-19 and obesity.

Europe Drug Review

EU Crunch Time Nears For Amgen’s Novel Lung Cancer Drug Sotorasib

The European Medicines Agency is expected to make recommendations on EU marketing authorization for 10 new medicines at its monthly meeting this week. They include products for non-small cell lung cancer, COVID-19, kidney disease, smallpox and migraine.

Europe Approvals

Cara Gets US Approval Of I.V. Korsuva, But Prospects Murky For Oral Version

The kappa opioid receptor agonist is not listed as a scheduled substance and labeling meets expectations. Cara and partner Vifor plan to launch the product in early 2022.

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