Myasthenia Gravis (MG) Archives - Page 2 of 2

FDA Greenlights Soliris for Rare Autoimmune Disease

Anti-aquaporin-4 (AQP4) antibody, Approvals, Biomarkers, Central Nervous System, European Medicines Agency (EMA), FDA, FDA/Regulatory, Generalized Myasthenia Gravis (gMG), Hemolytic Uremic Syndrome, Immune System, Japanese Ministry of Health, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Indications, Paralysis, Paroxysmal Nocturnal Hemoglobinuria (PNH), Vision problems

The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.

June 28, 2019/by BioSpace

Top 10 Pipelines To Watch: 2019 Annual Report

Analysts, Ankylosing Spondylitis (AS), Annual Reports, Antiretroviral Drugs, Atopic Dermatitis (Eczema), Autoimmune Diseases, B Cells, Big Pharma, Biologics, Biopharma, Biotechnology, Blockbusters, BRCA Gene, BRCA mutation, Breakthrough Therapy Designation, Business, Cancer, CAR-T Therapy, Cells, Chemotherapy, Clinical Data, Clinical Trials, Collaborations, Crohn's Disease, Cystic Fibrosis, Drug Discovery, EU, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, February 2019, Future Blockbusters, Gene Editing, Generalized Myasthenia Gravis (gMG), Genomics, HIV, Human Genome, Immune Cells, Immune System, Immune-Mediated Diseases, Immunotherapy, Inflammatory Diseases, Injectables, Innovation, Integrase strand transfer inhibitors, Issue Archives, Japan, M&A, Med Ad News, Monoclonal Antibodies, Multiple myeloma, Neoantigens, Neurology, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Non-Small Cell Lung Cancer (NSCLC), Nonalcoholic Steatohepatitis (NASH), Nuclear Medicine, Oncology, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Precision Medicine, Prescription Drug User Fee Act (PDUFA), Priority Medicines (PRIME) Designation, Priority Review Voucher, Product Pipelines, Proteins, Psoriatic Arthritis, R&D, Radioligands, Rare Disorders, Research, Rheumatoid Arthritis, RNA Interference (RNAi), Sickle Cell Disease, Small Molecules, Special Reports, T-Cells, Top 10 Pipelines, Top 10 Pipelines To Watch, Tumors, Ulcerative Colitis, Ultra Rare Diseases

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

February 13, 2019/by Andrew Humphreys

Soliris Receives Approval in Japan for gMG

Approvals, Biopharma, FDA/Regulatory, First-In-Class, Generalized Myasthenia Gravis (gMG), Japanese Ministry of Health, Neuromuscular Disorders

Alexion Pharmaceuticals Inc. announced that the MHLW in Japan approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis.

December 26, 2017/by Business Wire

Interim Analysis from Phase 3 Open-Label Extension Study Shows Sustained Benefits of Soliris Treatment for Patients with Refractory Generalized Myasthenia Gravis

Biopharma, Myasthenia Gravis (MG), Studies

Alexion Pharmaceuticals Inc. announced results from an interim analysis of an ongoing Phase 3 open-label extension study of the pivotal, placebo-controlled REGAIN study of Soliris (eculizumab) for the treatment of patients with refractory generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive.

September 13, 2017/by Business Wire