Phase III
Amid growing demands for generic versions of Vertex’s Trikafta, the company provided an update on the late-stage clinical development of its next-in-class triple combination for cystic fibrosis.
Data from a Phase III study show Genentech’s crovalimab is non-inferior to AstraZeneca’s Soliris, the current standard of care in paroxysmal nocturnal hemoglobinuria (PNH).
Industry leaders say the second generation of interventions for nonalcoholic steatohepatitis is likely to succeed where first-generation approaches stumbled.
Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
Sanofi is discontinuing its Phase III study of tolebrutinib, an investigational BTK inhibitor for myasthenia gravis.
Keytruda could be on its way to snagging another indication as a first-line therapy for endometrial cancer after the company announced positive Phase III results Friday.
Roche is dropping its investigational AKT inhibitor ipatasertib, which was being assessed in a Phase III trial for castration-resistant prostate cancer, as well as several other candidates.
Novartis is cleaning house, cutting its Huntington’s disease program along with several others. The company announced multiple program stops and delays in its full-year 2022 report Wednesday.
Novartis’ SCD therapeutic Adakveo is under review by the EMA after failing to replicate previous efficacy results in a Phase III trial.
The FDA granted Eli Lilly’s Jaypirca accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma.
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