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EU CHMP Backs Three Conditional Approvals & Several Treatment Firsts

 
• By Ian Schofield

Akcea’s Waylivra, Portola’s Ondexxya, BioMarin’s Palynziq, AbbVie’s Skyrizi and Pfizer’s Lorviqua are among new drugs to receive a positive opinion from the EU’s CHMP at its latest monthly meeting.

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Eight new drugs have cleared regulatory hurdles at the EU CHMP

At its final monthly meeting in London, the European Medicines Agency’s drug evaluation committee, the CHMP, gave the all-clear to all eight of the new drugs that were up for an opinion on EU marketing approval.

They included treatments for rare diseases with no available therapies, while three products were recommended for a conditional marketing authorization (CMA), meaning the companies will have to provide more data...

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