The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
AstraZeneca, Argenx Score Phase III Wins in Autoimmune Space
AstraZeneca, Autoimmune Diseases, Biologics, Bleeding Disorders, Central Nervous System, Chronic Immune Thrombocytopenia (ITP), Clinical Trial Endpoints, Clinical Trials, Generalized Myasthenia Gravis (gMG), Mayo Clinic, Medical Centers, Neuromyelitis Optica Spectrum Disorder (NMOSD), Primary Endpoints, R&D, Rare Disorders, Supplemental Biologics License Application, TherapeuticsTwo biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.
AstraZeneca’s Alexion Scores Third FDA Approval For Ultomiris
Alexion, Approvals, AstraZeneca, Blockbusters, C5 Complement Inhibitors, Clinical Trial Endpoints, Clinical Trials, FDA, Generalized Myasthenia Gravis (gMG), Neuromuscular Disorders, New England Journal of Medicine, New Indications, Primary Endpoints, R&D, Secondary Endpoints, Supplemental New Drug Application (sNDA), TherapeuticsAstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).
Global immunology firm Argenx shared positive topline results from the company’s ongoing study on the use of efgartigimod for generalized myasthenia gravis (gMG).
Belgium-based UCB hit the mark in the company’s Phase III clinical trial assessing zilucoplan as a potential treatment for adults with generalized myasthenia gravis, a rare autoimmune disease. Vanda Pharmaceuticals’ late-stage study of tradipitant as a treatment for the symptoms of gastroparesis, a digestive disorder, failed to meet the trial’s primary endpoint.
The U.S. Food and Drug Administration approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients positive for anti-acetylcholine receptor (AChR) antibody.
Boston-based Alexion Pharmaceuticals announced positive topline data from the company’s Phase III trial of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis.
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 problemsThe 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.
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 DiseasesThe 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.
Alexion Pharmaceuticals Inc. announced that the MHLW in Japan approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis.