EU CHMP

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.

Mavorixafor, X4 Pharmaceuticals/Norgine's treatment for WHIM syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.

Insight obtained by the Pink Sheet relating to the European Medicines Agency’s stricter approach to requests for clock-stop extension shows that refusals have not led to any companies withdrawing their marketing applications. On the contrary, companies were able to provide responses within the agreed timeframe after all.

Etuvetidigene autotemcel, Fondazione Telethon’s investigational gene therapy for Wiskott-Aldrich syndrome, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The European Medicines Agency has recommended eight new products for EU-wide approval, including cancer treatments and vaccines, and Ok'd a new antiparasitic combination for use in non-EU markets. It is also reviewing new safety information on Leqembi.

Servier is set to make its case before the European Medicines Agency for the EU-wide approval of its innovative therapy for Grade 2 IDH-mutant glioma.

Antibody-drug conjugates for treating cancer and vaccines to protect against chikungunya and pneumococcal pneumonia are among several products being considered for marketing approval by the European Medicines Agency’s human medicines committee, the CHMP.

The European Medicines Agency’s chief medical officer, Steffen Thirstrup, said the surge in positive opinions adopted by the agency in 2024 for new marketing approvals signals a post-COVID recovery.

Marketing authorization applications for five new advanced therapy medicinal products were filed with the European Medicines Agency in 2024, the highest number in any year since 2020. The Pink Sheet looks at these and two other ATMPs that might get the thumbs up from the European Medicines Agency in 2025.

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.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The European Medicines Agency has recommended several new products for pan-EU approval, including CSL Behring’s drug for hereditary angioedema and BridgeBio’s treatment for transthyretin amyloidosis in cardiomyopathy patients.

Sponsors of 13 new products, including BridgeBio’s acoramidis, could soon learn whether or not the European Medicines Agency recommends their drugs for pan-EU marketing approval.

Elinzanetant, Bayer’s investigational treatment for hot flashes in menopausal women, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Sanofi’s rilzabrutinib and Alvotech/Advanz Pharma’s golimumab (AVT05) are among five new entries on the European Medicines Agency’s latest monthly list of products for which marketing applications are currently under review. Both drugs are investigational and are yet to be approved anywhere in the world.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.