THOUSAND OAKS, Calif. – Amgen has mounted a comprehensive defense of its rare disease drug Tavneos as it seeks to prevent the FDA from withdrawing the therapy from the U.S. market over safety concerns. The company announced Friday that it had formally requested an FDA hearing after submitting a package...
treatment News
THOUSAND OAKS, Calif. — Amgen announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company’s supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib). This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for...
THOUSAND OAKS, Calif. — Amgen (NASDAQ:AMGN) today announced that the global Phase 3 DeLLphi-304 clinical trial evaluating IMDELLTRA® (tarlatamab-dlle) as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy met its primary endpoint at a planned interim analysis. IMDELLTRA...
Thousand Oaks, CA – Amgen’s anti-CD19 antibody Uplizna maintains and improves treatment response in patients with generalized myasthenia gravis through 52 weeks of follow-up, according to a Phase III readout posted Wednesday. These findings, revealed in an abstract for the upcoming meeting of the American Academy of Neurology (AAN), “do look strong,”...
Ridgeland, MS — Amicus Therapeutics (FOLD) has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease. The Company has reached agreement with the FDA on the key protocol design elements of the pivotal trial, including the use of the...
LEIDEN, The Netherlands – Amifampridine, the active ingredient in Firdapse, provides meaningful clinical benefits for people with Lambert-Eaton myasthenic syndrome (LEMS), while the use of immunosuppressive therapies tends to increase as the disease progresses, according to a long-term study conducted at a Dutch medical center. The study also found that...
BRIDGEWATER, N.J. — Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and Shilpa Medicare Limited (“Shilpa”) today announced the U.S. launch of BORUZU™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation...
BRIDGEWATER, N.J. — Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe. The product references SOMATULINE® Depot and will launch immediately. The product received Competitive Generic...
BRIDGEWATER, N.J — Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an authorized generic of sodium oxybate oral...
– Additional research centers now enrolling patients in Australia and New Zealand – Company has achieved 50 percent of target enrollment in global Phase 3 trial LONDON – AMO Pharma Limited (“AMO Pharma”), a privately held biopharmaceutical company focusing on rare childhood-onset neurogenetic disorders with limited or no treatment options, today announced the...