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EU Approves Gilead’s Remdesivir For COVID-19 In Record Time

Despite The Controversy, Blockbuster Status Is Predicted

 
• By Andrew McConaghie

The EU has granted conditional marketing approval to Gilead’s drug, which has the brand name Veklury. It will cost about €2,000 per treatment.

Vials_Remdesivir
There are concerns over the supply of remdesivir for COVID-19 • Source: Shutterstock

The European Commission's decision to issue a conditional marketing authorization for Gilead Sciences Inc.'s COVID-19 therapy, Viklury (remdesivir), comes just eight days after the European Medicines Agency's drug evaluation committee, the CHMP, delivered a positive opinion on the product's approval. In normal circumstances the commission has 67 days in which to grant an MA after a CHMP recommendation. (Also see "Remdesivir’s EU Approval For COVID-19 Due Within Days" - Pink Sheet, 25 June, 2020.) 

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More from Europe

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

 
• By Neena Brizmohun

A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.

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

 
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New EU Approvals

 
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Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
• By Eliza Slawther

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.

More from Geography

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

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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.