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Latest From Dr. Falk Pharma GmbH

Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

Rare Diseases Drug Approval Standards

Eleven New Drugs Filed In EU; Sipavibart & Dorocubicel Win Fast-Track Status

AstraZeneca’s sipavibart for preventing COVID-19 in the highly vulnerable population of immunocompromised patients is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.

Europe Approvals

CNS Drugs Are Surprisingly Valuable

An analysis of the most valuable research-stage products pinpoints several neurological candidates – and a deeper dive into this segment shows more CNS therapies that look to be worth big money.

Clinical Trials Commercial

Asia Deal Watch: Chugai Extends Relationship With Helsinn

Plus deals involving Kissei/JWP, Shionogi/Cilcare, Takeda/Torrent, Genome & Co./Debiopharm, Kaken/J&J, CStone/Ewopharma, MediLink/BioNTech and more.

Deal Watch Business Strategies
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