Roche aims to defend the company’s multiple sclerosis (MS) franchise from rivals Novartis and Sanofi with new studies of the Swiss drugmaker’s $4 billion-per-year Ocrevus product and advanced trials of the experimental medicine fenebrutinib.
Novartis announced that the Phase III COMBI-I trial of the company’s experimental checkpoint inhibitor spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) failed to hit the primary endpoint in melanoma.
Several studies suggest that even mild cases of Covid-19 stimulate lasting immune responses, not only in disease-fighting antibodies, but in B-cells and T-cells.
The U.S. Food and Drug Administration approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis in adults.
Sanofi is rumored to have a $50 billion budget for mergers and acquisitions and is taking a look at U.S.-based biotech companies, including South San Francisco-based Principia Biopharma.
One day, cell and gene therapies will be as common as small molecules and antibody-based therapies are today, according to panelists at BIO 2020.
FDA Action Alert
Atopic Dermatitis (Eczema), Auto-Injection Therapy, B Cells, Biologics License Application (BLA), Complicated Urinary Tract Infections (cUTI), Diabetic Gastroparesis, Eosinophilic Asthma, FDA, FDA/Regulatory, Follicular Lymphoma, Inflammatory Diseases, Monoclonal Antibodies, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Pediatric Asthma, Prescription Drug User-Fee Act (PDUFA), Priority Review Status, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA)A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
The immuno-oncology therapy CAR-T utilizes specific types of immune cells, T-cells, which are drawn from the cancer patient, supercharged and infused back into the patient. Now, The University of Texas MD Anderson Cancer Center has developed a slightly different approach using a different type of immune cell called Natural Killer (NK) cells.
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.
Eli Lilly and Company and Loxo Oncology Inc. announced a definitive agreement for Lilly to acquire Loxo for $235.00 per share in cash, or approximately $8.0 billion.