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AOP Orphan Pharmaceuticals AG

http://www.aoporphan.com/

Latest From AOP Orphan Pharmaceuticals AG

Strides’ Teriparatide And Viatris’ Pirfenidone Receive CHMP Nods

Strides Pharma’s biosimilar teriparatide version of Forsteo has been granted a positive opinion by the EMA’s CHMP, setting the firm up for a pan-European marketing authorization along with Viatris’ pirfenidone generic rival to Esbriet and AOP Orphan Pharmaceuticals’ sugammadex generic of Bridion.

Europe Biosimilars

Sanofi & GSK Win COVID-19 Vaccine Approval In EU Using Immunobridging Trials

The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.

Europe Approvals

Keeping Track: GSK’s Priorix Makes Three Novel US FDA CBER Approvals In 2022; Two CV Drugs Among Recent NDAs

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Roche Shelves Phase III Huntington's Candidate Tominersen

Roche’s Phase III of tominersen in Huntington's disease has been stopped after an independent interim review, but with no new or emerging safety signals reported, analysts presume efficacy was the problem.

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