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EU Crunch Time For 15 New Drugs At Final CHMP Meeting Of 2021

Oral Explanation Meetings Possible For Four Marketing Applications

 
• By Neena Brizmohun

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.

Question marks background. High resolution 3d render
A number of companies are set to find out if their drugs will receive EU approval • Source: Alamy

The European Medicines Agency is this week set to decide whether to recommend pan-EU marketing approval for 15 new drugs, including Xevudy (sotrovimab),Vir Biotechnology/GlaxoSmithKline’s COVID-19 treatment, and linzagolix, from ObsEva, for managing heavy menstrual bleeding associated with uterine fibroids.

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Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 
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EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

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EU Pharmacopoeia Adopts ‘Groundbreaking’ Cell Therapy Chapter, Seeks Feedback On Alternative Microbiological Tests

 
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New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

More from Geography

EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
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Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

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