Luxembourg – In a new position paper, and following engagement with its national members and the European Working Group of People with Dementia (EWGPWD), Alzheimer Europe calls for concrete actions to enable timely, safe and equitable access to anti-amyloid drugs, for patients who are most likely to benefit from these...
treatment News
FRAMINGHAM, Mass. — Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced its participation in the Nobel Forum “Challenges for Implementation of New Alzheimer’s Disease Treatments” covering Alzheimer’s therapeutics for...
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...
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...
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...
– 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...
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...