EU Crunch Time For 15 New Drugs At Final CHMP Meeting Of 2021
Oral Explanation Meetings Possible For Four Marketing Applications
Drugs for COVID-19, Alzheimer’s disease and heavy menstrual bleeding due to uterine fibroids are among the latest products that are this week being considered for marketing approval by the European Medicine Agency’s human drugs evaluation committee, the CHMP.
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A first-of-its-kind drug for uterine fibroids and a new monoclonal antibody treatment for COVID-19 are among several new drugs recommended for pan-EU approval this month.
New data that is being collected to support a US resubmission for Intercept’s obeticholic acid might also be used to support a resubmission to the European Medicines Agency.
New developments on the COVID-19 front also include the European Medicines Agency starting a rolling review of Valneva’s investigational COVID-19 vaccine, and the UK government signing contracts with Pfizer/BioNTech and Moderna to buy more doses of their vaccines.