EU Crunch Time For Mirikizumab, New COVID-19 Vaccine & Other Drugs
The European Medicines Agency’s human medicines committee, the CHMP, is this week deciding whether to back marketing approval for eight new drugs and a coronavirus vaccine.
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Lilly’s Omvoh Among Nine New Drugs Securing EU Marketing Thumbs Up
A number of new drugs have taken a major step towards being approved for use in the EU after receiving the nod from the European Medicines Agency’s human medicines committee, the CHMP. Meanwhile, the marketing applications for three drugs have been withdrawn.
Pharma Industry On How To Tackle EU Regulatory & Reimbursement Barriers To Digital Therapeutics
When it comes to digital therapeutics in Europe, EFPIA says there is a lack of harmonization in the regulatory requirements, and only Belgium and Germany offer value assessment, reimbursement and funding pathways, with more intermittent offerings in countries like France and UK.
BMS & Pfizer Win Funding ‘Firsts’ In England For Migraine & Heart Disease Drugs
Bristol Myers Squibb and Pfizer both asked the health technology assessment body NICE to evaluate their respective drugs, Camzyos and Vydura, for use in indications that are narrower than those for which they are – or will potentially be – approved.