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Latest From Neuraxpharm Arzneimittel GmbH

EU Crunch Time For Myriad Drugs Marks A Busy May Meeting For CHMP

The latest meeting of the European Medicines Agency’s human medicines committee, the CHMP, is taking place this week. Decisions are expected for 13 drug marketing applications, there will be a number of oral explanation meetings, and activity is expected relating to a drug at the center of a case involving the European Commission’s rejection of an EMA recommendation.

Drug Review Approvals

One Foot In The Door? Trio Look To Reenter Annulled EU Generic Tecfidera Market

A topsy-turvy legal battle going back some years led to a raft of Tecfidera generics being pulled from the market in December last year. Now, three of the affected companies are a step closer to reentering the market, which is set to remain a Tecfidera monopoly until February 2025.

Drug Review Generic Drugs

EMA Says Yes To 12 New Drugs Including Pfizer/AbbVie’s Antibiotic Combo

Emblaveo, for fighting infections caused by multidrug-resistant bacteria, is among the latest batch of medicines that the European Medicines Agency says should be approved for use in the EU.

Europe Approvals

Neuraxpharm Vows Swift Appeal Over Pulled EU Tecfidera Generics

Neuraxpharm has vowed to rapidly challenge a legal decision that has seen generic rivals to Biogen’s Tecfidera (dimethyl fumarate) multiple sclerosis treatment pulled from the market in Europe.

Legal Issues Intellectual Property
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