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Janssen Pharmaceuticals Inc.

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Latest From Janssen Pharmaceuticals Inc.

First-In-Class Vorasidenib Among Bumper Crop Of New EU Filings

Twelve new drugs are now being reviewed for potential EU marketing approval, including Servier’s vorasidenib for IDH-mutant diffuse glioma, which the company says could become the first targeted therapy for the malignant and incurable brain tumor.

Europe Drug Review

PhRMA’s Lawsuit Against Medicare Trips Over ‘Administrative Remedy’ Standard; Will Others?

West Texas District Court dismisses lawsuit against Medicare price negotiation program on jurisdictional grounds without considering the merits of the case. PhRMA is weighing next steps.

Reimbursement Policy

Deal Watch: Novartis Partners In CNS Gene Therapies A Second Time With Voyager

Plus deals involving AstraZeneca/Allorion, Concentra/Theseus, Janssen/MeiraGTx, Lilly/Fauna and more.

Deal Watch Business Strategies

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

BioPharmaceutical Market Access
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