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...
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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,”...
PHILADELPHIA & NEW YORK – Amicus Therapeutics, Inc. (Nasdaq: FOLD) (“Amicus”) announced its intent to launch a next-generation genetic medicine company, Caritas Therapeutics, Inc., (“Caritas”) through a definitive business combination agreement pursuant to which the Amicus gene therapy business will be acquired by ARYA Sciences Acquisition Corp IV (Nasdaq: ARYD)...
PHILADELPHIA – Amicus Therapeutics (Nasdaq: FOLD), today announced the election and appointment of Eiry W. Roberts, M.D. to its Board of Directors. Dr. Roberts is an esteemed drug developer who brings approximately 30 years of pharmaceutical industry experience to the Company’s Board of Directors, having served in various leadership positions...
PHILADELPHIA – Amicus Therapeutics (Nasdaq: FOLD) today announced the appointment of Sébastien Martel as Senior Vice President of Strategy and Business Development. Mr. Martel will lead the Company’s corporate strategy and business and corporate development endeavors. He will be a member of the Amicus senior leadership team. Mr. Martel brings...
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...
REDWOOD CITY, Calif. – AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative treatments with its proprietary dual anti-inflammatory/anti-fibrotic therapeutic platform targeting the colony-stimulating factor 1 receptor (CSF1R), today announced that John Varian has been appointed as an Independent Board Member. “We are very happy to welcome John...