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Actelion Pharmaceuticals Ltd.

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Latest From Actelion Pharmaceuticals Ltd.

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

Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials

Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.

Infectious Diseases Review Pathway

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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Company Information

  • Other Names / Subsidiaries
    • Ceptaris Therapeutics, Inc. (Yaupon Therapeutics, Inc.)
    • CoTherix, Inc
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