Incyte Corporation’s pivotal Phase III GRAVITAS-301 trial of itacitinib in combination with corticosteroids in treatment-naïve acute graft-versus-host disease (GVHD) did not hit the primary endpoint, sending company shares down almost 10 percent.
Dublin, Ireland-based Alkermes is acquiring Boston-based Rodin Therapeutics for $100 million up front and up to $850 million in milestone payments.
Sanofi is pressing the U.S. Food and Drug Administration to keep the company’s patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.
Gilead Sciences Inc. and Galapagos NV announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib – an investigational, oral, selective JAK1 inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) – are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier during 2019.
Shionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).
Shares of Dova Pharmaceuticals were up more than 38 percent after Sweden-based Sobi announced the intended acquisition of the North Carolina-based company for $915 million.
Eton Pharmaceuticals Inc. announced that Aucta Pharmaceuticals Inc.’s New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, was accepted for review by the U.S. Food and Drug Administration.
Two weeks after the U.S. FDA rejected Acer Therapeutics’ New Drug Application for Edsivo (celiprolol), the company initiated a restructuring plan that includes the elimination of 29 employees.
Less than a month after filing for bankruptcy, Insys Therapeutics gained a reprieve from some lawsuits as well as a path forward for regulatory approval of an opioid overdose treatment.
With an opioid molecule awaiting regulatory review, Nektar Therapeutics announced the launch of Inheris Biopharma, which will be responsible for the commercialization of NKTR-181.