European Performance Tracker
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Top Seven Pink Sheet Infographics Of 2023
A visual perspective on key regulatory topics in 2023, from clinical trial diversity to product approval trends and Medicare drug price negotiation.
EU Accelerated Assessment: Lilly Requests Fast-Track Status, EMA Says No To SIFI And Janssen
Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy.
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
EU Biosimilar Filings, Opinions And Approvals
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.
EU Accelerated Assessment Tracker
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.
EU Accelerated Assessment Tracker
Janssen-Cilag's EU filing for teclistamab is being reviewed under the European Medicines Agency’s accelerated assessment procedure. The outcome of Sanofi’s request relating to nirsevimab is not yet in the public domain.
EU Accelerated Assessment Tracker
The filing for Origin Biosciences’ fosdenopterin (Nulibry) is being fast-tracked at the European Medicines Agency. The outcomes of accelerated assessment requests from Janssen and Sanofi for teclistamab and nirsevimab respectively appear not yet to be in the public domain.
EU Accelerated Assessment Tracker
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.
EU Accelerated Assessment Tracker
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from, among others, Janssen, Sanofi, Boehringer Ingelheim and Mirum.
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