Alkermes plc announced the initiation of its rolling submission of a New Drug Application to the U.S. Food and Drug Administration, seeking marketing approval of ALKS 5461. The once-daily, oral vestigational medicine with a novel mechanism of action is intended for the adjunctive treatment of major depressive disorder MDD).
Ocular Therapeutix’s NDA resubmission for DEXTENZA 0.4 mg for ocular pain occurring after ophthalmic surgery was accepted as a filing for review by FDA.
Eagle Pharmaceuticals Inc. announced that it has completed the submission of its 505(b)(2) New Drug Application for Ryanodex for the treatment of exertional heat stroke (EHS) to the U.S. Food and Drug Administration.
Vifor Fresenius Medical Care Renal Pharma obtains rights to commercialize RAYALDEE in Europe, Canada and certain other international markets; OPKO Health to receive up to $282 million in upfront and milestone payments, plus tiered double-digit royalties.
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.
REDWOOD CITY, Calif.–(BUSINESS WIRE)–Heron Therapeutics, Inc. (NASDAQ:HRTX), announced today that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of […]