The U.S. FDA approved Merck’s supplemental New Drug Applications for Pifeltro (in combination with other antiretroviral agents) and Delstrigo (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro or the individual components of Delstrigo.
The U.S. Food and Drug Administration approved a combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available kinase inhibitor Lenvima for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
Celgene’s Phase 3 Study of CC-486 as Maintenance Therapy in Patients With Newly Diagnosed AML Met Primary and Key Secondary Endpoints
Celgene Corporation announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study QUAZAR AML-001.
Checkpoint Surgical Inc. – a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair – received Breakthrough Device designation from the U.S. Food and Drug Administration for the Checkpoint brief electrostimulation therapy (BEST) system.
The European Commission approved Bristol-Myers Squibb Co.’s Empliciti plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.
U.S. FDA Grants Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer
The U.S. Food and Drug Administration accepted for review Astellas Pharma Inc.’s filing of a supplemental New Drug Application for Xtandi (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer.
European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis
Gilead Sciences Inc. and Galapagos NV announced that the Marketing Authorization Application for filgotinib – an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis – was validated and is under evaluation by the European Medicines Agency.
Harvard University and Merck launched a collaboration that will provide significant research funding for up to four years to support immuno-oncology research led by Arlene Sharpe, MD, PhD, at Harvard Medical School (HMS).
Kala Pharmaceuticals Inc. received a complete response letter from the U.S. Food and Drug Administration regarding the company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
W2O announced that former network news reporter Barbara Pinto has been named Practice Leader, Executive Communications.