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...
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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...
– 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...
NEW YORK – Amplo Biotechnology, a privately held US-based biotech focused on developing AAV (Adeno-associated Virus)-based gene therapies for diseases affecting the neuromuscular junction, today announced the successful closing of an undisclosed Series Seed financing. The Seed round was led by BioBrit, LLC., joined by Casdin Capital, SeedFolio and small...
LINKÖPING, Sweden – AMRA announced today that its magnetic resonance imaging (MRI) based method has sufficient sensitivity to detect disease progression at the muscular level in ReDUX4: a multicenter Phase 2b clinical trial testing the safety and efficacy of Losmapimod in treating facioscapulohumeral muscular dystrophy (FSHD). The study introduced a powerful new method in...
ALBANY, N.Y. – Albany Molecular Research, Inc. (AMRI), a leading global provider of advanced contract research, development and manufacturing solutions, today announced expanded access to its accelerated solutions platform, spanning research & development to manufacturing for orphan and rare disease products. The company has made targeted investments globally to expand its...