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.
Gilead Sciences has been accused of withholding safer formulations of its HIV drugs in order to maximize profits on those medications that had already been approved, such as Truvada.
Johnson & Johnson expects to file marketing applications for at least 10 new drugs between 2019 to 2023, to strengthen the company’s pharma unit which has been a major growth driver.
Mallinckrodt plc announced that the company achieved target enrollment of 300 participants in the Phase 3 CONFIRM clinical study to evaluate the efficacy and safety of the investigational agent terlipressin in adult patients with Hepatorenal Syndrome Type 1 (HRS-1).
Cambridge, Mass.-based Alnylam Pharmaceuticals indicated that the company’s ENVISION Phase III trial of givosiran was positive for acute hepatic porphyria (AHP).
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
UroGen Pharma announced positive top-line results from the New York based-company’s Phase III OLYMPUS clinical trial that evaluated UGN-101 (mitomycin gel) for instillation for the non-surgical treatment of low-grade upper tract urothelial cancer.
Kala Pharmaceuticals Inc. announced that the New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States Food and Drug Administration FDA.