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.
Here is a look at BioSpace’s top 10 stories of 2018.
Ann Arbor, Mich.-based Esperion Therapeutics reported final results from a long-term safety study of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) whose disease is inadequately controlled by statins.