LILLE, France — ALZPROTECT is thrilled to announce that it has received favorable feedback from both the U.S. food and drug administration (FDA) and European Medicines Agency (EMA) regarding the regulatory path for advancing the clinical development of Ezeprogind/AZP2006 for patients with PSP. This significant milestone follows the already very...
treatment News
DUBLIN — Amarin Corporation plc (NASDAQ:AMRN) today announced encouraging top line results from an exploratory Phase 2a multi-centre, dose-ranging, cross-over clinical study of EN101 in patients with myasthenia gravis, a chronic autoimmune disease characterized by muscle weakness which can be life-threatening. Thomas Lynch, Chairman and Chief Executive Officer of Amarin,...
THOUSAND OAKS, Calif. — Amgen (NASDAQ:AMGN) will host a webcasted call at 1:00 p.m. PT on Thursday, February 22, 2024 to discuss Rare Disease, its newly added fourth pillar of growth, and provide insights on its rare disease strategy and opportunities, including marketed products and pipeline. Murdo Gordon, executive vice...
THOUSAND OAKS, Calif. – Amgen (NASDAQ: AMGN) today announced the launch of Biomarker Assist™, a program to help more patients with metastatic (stage IV) non-small cell lung cancer (NSCLC) gain access to biomarker testing. Biomarker testing at the time of diagnosis is a critical first step in getting patients on...
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...
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”) 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...