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Latest From Orphan Therapeutics, LLC

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regional Comparisons Approvals

Deal Watch: Lilly Partners With OpenAI On Drug-Resistant Pathogens

Plus transactions involving ANI/Alimera, Gilead/ashibio, Sanofi/Belharra and more.

Deal Watch Business Strategies

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

The US FDA approved Day One’s pediatric brain cancer drug Ojemda, ImmunityBio’s bladder cancer immunotherapy Anktiva, an uncomplicated UTI claim for Utility Therapeutics’ Pivya, which has a long history in Europe, and Pfizer’s hemophilia B gene therapy Beqvez.

US FDA Performance Tracker Approvals

Deal Watch: Six Small Biopharma Mergers Reflect Recent Trend

M&A edition: Mergers by Century/Clade, Eliem/Tenet, Kintara/TuHURA, Aditxt/Appili, Onconova/Traws and Apotex/Searchlight follow other companies joining forces in a tight cash environment.

Deal Watch M & A
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