Surface Oncology agreed to grant exclusive worldwide licensing rights to GlaxoSmithKline for the development and commercialization of the Cambridge, Mass.-based biotech company’s SRF813, a fully human IgG1 antibody and immunotherapy designed to treat cancer.
FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida
Adeno-Associated Virus (AAV), B Cell Lymphomas, Biologics License Application (BLA), Brain Metastases, CAR-T Therapy, Chronic Kidney Disease, Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Hemophilia A, HER2-positive breast cancer, Immunotherapy, New Drug Applicationa, Project Orbis, Quarterly results, T-CellsThe U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma
FDA, FDA/Regulatory, Immunotherapy, New Drug Application Submission, Renal Cell Carcinoma (RCC), Tyrosine kinase inhibitors, Vascular Endothelial Growth Factor (VEGF) InhibitorsAVEO Oncology submitted a New Drug Application to the U.S. Food and Drug Administration for tivozanib, the company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, as a treatment for relapsed or refractory renal cell carcinoma (RCC).
More than 17.6 million American adults (about 7.5 percent) experience allergic rhinitis (also called hay fever or seasonal allergies). Many different substances (called allergens) can trigger allergic rhinitis, such as tree or grass pollen, and each person has their own set of problematic allergens.
The U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy Palforzia as a first-of-its-kind treatment for the millions of people suffering from an allergy to peanuts.
Arcus Biosciences and Roche company Genentech are partnering on two clinical trials for colorectal and pancreatic cancer.
The U.S. Food and Drug Administration approved Astellas Pharma Inc. and Seattle Genetics Inc.’s experimental drug Padcev to treat advanced bladder cancer, about three months ahead of schedule.
Roche’s immunotherapy Tecentriq combined with the Swiss drugmaker’s Avastin medicine helped people with the most common form of liver cancer to live longer than with an older drug from Germany’s Bayer.
Merck Acquires Immune Design
Acquisitions, Business, Cancer, Cellular immunotherapy, Cellular immunotherapy, Chronic Diseases, Collaborations, Health Technology, Immune Cells, Immune System, Immunizations, Intratumoral TLR4 agonists, Investigational New Drug (INDs) submissions, Oncology, Sarcomas, Shares, Synovial sarcoma, T-CellsShares of Immune Design skyrocketed after Merck announced the acquisition of the Seattle-based oncology company for $300 million in cash.
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.