Novartis AG received breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental treatment for advanced castration-resistant prostate cancer, the Swiss drugmaker said on June 16.
Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.
2016 Annual Report: Top 10 Pipelines
"Bad" LDL Cholesterol, Alzheimer's Diseases, Approvals, Big Pharma, Biologics License Application (BLA), Biosimilars, Biotech, Biotech/Biopharma, Biotechnology, Bispecific CD19-directed CD3 T cell engager (BiTE) antibodies, Blockbusters, Blood Cancers, Breakthrough Designation, Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Cells, Chimeric Antigen Receptor T Cell Therapy (CART), Cholesterol, Chronic Lymphocytic Leukemia, Clinical Trials, Collaboration, Collaborations, Collaborations, Cystic Fibrosis, Deals, Diabetes, DNA, EGFR Inhibitors, Europe, European Commission, FDA, FDA/Regulatory, February 2016, Glucagon-Like Peptide-1 (GLP-1) Analogs, Immune Response, Immune System, Immune Systems, Immunotherapies, Influenza, Inhalers, Issue Archives, Mantle Cell Lymphoma (MCL), Monoclonal Antibodies, Multiple Myeloma, NDA, Neuroscience, New Drug Application (NDA), New Molecular Entities, Non-Small Cell Lung Cancer, Oncology, Pain, Parkinson's, Parkinson's Disease, Plaque Psoriasis, Potential Blockbusters, Psoriasis, R&D, Sales, SGLT2 Inhibitors, Special Reports, Specialty Therapy, Technology, TGF-Beta Inhibitors, The New England Journal of Medicine (NEJM), Therapeutics, Top 10 Pipelines, Transforming Growth Factor-beta (TGFb), Type 1 Diabetes, Type 2 Diabetes, Vaccines, Waldenstrom’s macroglobulinemiaThe pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.