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European Commission Steps Further Towards ‘Ambitious’ Pharma Legislation Reform

 
• By Francesca Bruce

The incentives system, access to medicines, future proofing for novel products and antimicrobial resistance are just some of the topics included in a new consultation.

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The European Commission Is Consulting On Ambitious Reform

In another step towards what looks set to be a major revision of the EU’s pharmaceutical legislation, the European Commission has published a consultation touching on a wide range of areas that are potentially ripe for reform. It is seeking opinions on measures to improve the incentives system, such as linking incentives to how well a company reports R&D costs, and to drive access to medicines by obliging companies to launch their products in most EU markets.

The commission says that the consultation is “the latest step towards an ambitious reform” and is part of its wider...

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
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The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.