Amarin Corp. provided an update, noting that the company is increasing revenue guidance for 2019 and is planning to expand the sales force for Vascepa due to faster-than-expected growth.
FDA approves expanded label for Praluent
"Bad" LDL Cholesterol, Approvals, Biotech, Cardiovascular Events, Cholesterol, Drug Pricing, Expanded Label, FDA, FDA/Regulatory, Heart Attacks, Heterozygous Familial Hypercholesterolemia (HeFH), Injectables, Major Adverse Cardiovascular Events (MACE), PCSK9 inhibitors, Statins, StrokeThe U.S. Food and Drug Administration approved Regeneron Pharmaceuticals’ cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.
Kowa Pharmaceuticals America Inc. today announced publication of results of the INTREPID Trial (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) in The Lancet HIV. Results of the Phase 4 trial showed that LIVALO (pitavastatin) 4 mg was superior to pravastatin 40 mg in reducing LDL cholesterol (LDL-C) in adults with HIV and dyslipidemia and had a comparable safety profile.
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.