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Sentynl Therapeutics, Inc.

http://www.sentynl.com/

Latest From Sentynl Therapeutics, Inc.

As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

US FDA Performance Tracker Drug Review

Orphans Account For More Than A Third Of EU New Drug Approvals In 2022

Last year, the European Commission approved a record 55 therapies containing a new active substance, including 21 medicines for rare diseases. Among them were a number of gene therapies for indications such as cancer and hemophilia.

Europe Approvals

RWE’s Biggest Role In US FDA Approvals: External Controls For Breakthrough Rare Disease Therapies

Despite broad interest, real-world evidence of efficacy in FDA decisions remains largely limited to orphan diseases and natural history, a Pink Sheet analysis shows.

Real-World Evidence Rare Diseases

Finance Watch: Bausch + Lomb Completes Split From Bausch Health Via IPO

Public Company Edition: Bausch remains the majority shareholder, but B+L is a separate operating company. Also, Rezolute raises $130m in dual financings and BridgeBio outlines job cuts and will out-license assets to conserve cash.

Financing Business Strategies
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