Orphan Therapeutics, LLC
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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.
Deal Watch: Lilly Partners With OpenAI On Drug-Resistant Pathogens
Plus transactions involving ANI/Alimera, Gilead/ashibio, Sanofi/Belharra and more.
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.
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.
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