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Article EMA Thank You What we expect European regulators to do in April 2024

Agency IQ

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

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Recon: Sanofi, GKS report positive interim results for COVID shot; Regeneron resumes lymphoma trials

The Pharma Data

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ). Now they fear an increase. BioPharmaDive ).

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