Sentynl Therapeutics, Inc.
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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.
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.
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.
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.
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Pharmaceuticals
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