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Janssen-Cilag International

www.janssen-cilag.com

Latest From Janssen-Cilag International

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.

Europe European Performance Tracker

Janssen And Sanofi Keep Mum On EU Fast-Track Request Outcomes

Teclistamab and nirsevimab may or not be fast-tracked when their sponsors – Janssen-Cilag and Sanofi, respectively – file for pan-EU approval. In the meantime, a total of seven filings are currently benefiting from the accelerated assessment mechanism at the European Medicines Agency. 

Europe Review Pathway

US ‘Lags Behind’ EU & Canada On Clinical Data Transparency

The US Food and Drug Administration has proactively released data for just one drug, compared with data released for over 100 drugs by the European Medicines Agency and just over 70 drugs by Health Canada, according to a study that compared the accessibility and comprehensiveness of the data that the three regulators proactively or reactively disclose.

Europe North America

Gilead’s First-In-Class Drug For Aggressive Breast Cancer On Track For EU Approval

EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

Approvals Drug Review
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