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Gilead’s Lenacapavir, Takeda’s Maribavir Due For Oral Explanations At EMA

 
• By Vibha Sharma

The sponsors of four drugs were due or possibly due to appear before the European Medicines Agency to explain why their respective products merit EU-wide approval.  

Concept of EMA European Medicines Agency. Drugs evaluation and quality control, standards compliance department.
Oral explanations give companies a chance to explain why their drugs deserve EU-wide approval • Source: Shutterstock

Gilead Sciences is among the drug sponsors that were due to appear before the European Medicines Agency this week to explain why their products that are in the final stages of regulatory review should be recommended for EU-wide marketing approval. 

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EU Biosimilar Filings, Opinions And Approvals

 
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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

 
• By Eliza Slawther

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

 
• By Eliza Slawther

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.

More from Geography

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 
• By Sarah Karlin-Smith

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

Confirmatory Trials: Industry Wants Timely Protocol Feedback, More Clarity On ‘Due Diligence’

 
• By Sue Sutter

Consumer and academic group comments on accelerated approval and confirmatory trial guidances say the proposed criteria for determining when a study is underway are too vague.

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

 
• By Eliza Slawther

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.