Actelion Pharmaceuticals Ltd.
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Latest From Actelion Pharmaceuticals Ltd.
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.
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.
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.
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.
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