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Janssen Pharmaceuticals Inc.

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Latest From Janssen Pharmaceuticals Inc.

EU Accelerated Assessment Tracker

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, five requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

Europe Review Pathway

US FDA’s Novel Approval Count Hits 32 In First Half Of 2021, With More Than 40 Goal Dates Ahead

CDER approved a record 27 novel agents between January and June, while a wave of cell therapy and vaccine applications could carry the biologics center to new heights. Merck could close year with four novel approvals.

Approvals Drug Review

FDA On What Aduhelm AdCom Got Wrong: Statistics, Investigational Drugs, Patient Perspective

After a searing advisory committee on aducanumab, FDA reviewers undertook an extensive effort to counter or discount the panel’s criticisms, newly released review documents show. Among the unusual moves by the agency was the citation of data from two investigational products, Lilly’s donanemab and Biogen/Eisai’s BAN2401, as evidence in support of aducanumab.

Drug Approval Standards Advisory Committees

Keeping Track: US FDA Issues Alzheimer’s Breakthrough Designations, Arimoclomol CRL, Rinvoq Delays

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals
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