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Latest From Alkermes plc

Keeping Track: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Approvals Review Pathway

Deal Watch: Sol-Gel To Tackle Gorlin Syndrome In Pact With BridgeBio’s PellePharm

Shoreline picks up technology platform rights and access from Editas, which recently reduced staff. Hyloris out-licenses commercial rights to Maxigesic in nine EU markets to Salus.

Deal Watch Business Strategies

J&J/Legend’s Carvykti Data Show Earlier-Line Efficacy As Commercial Headwinds Remain

The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.

ImmunoOncology Cancer

EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos

The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.

Europe Approvals
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