American Medical Systems Holdings, Inc
http://www.americanmedicalsystems.com
Questions?
Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From American Medical Systems Holdings, Inc
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.
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.
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.
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.