A leading British scientist made a significant breakthrough in the race for a coronavirus vaccine by reducing a part of the normal development time from “two to three years to just 14 days”, Sky news reported.
The European Commission approved Astellas Pharma’s oral once-daily therapy Xospata as a monotherapy for treating adults with relapsed or refractory acute myeloid leukemia with a FLT3 mutation.
EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.
An HIV-positive man in Britain became the second known adult worldwide to be cleared of the AIDS virus after he received a bone marrow transplant from an HIV resistant donor, his doctors said.
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.
UK Biopharma and life after Brexit
Biomedicine, Brexit, Business, EMA, EU, European Economic Area, European Free Trade Association (EFTA), Life Sciences, Marketing Authorization Application (MAA), Medical Devices, National Institute for Health and Care Excellence (NICE), Orphan Drug Designation, Personalized Medicine, Pharma, Pharmacovigilance, Pricing, R&D, Switzerland, United Kingdom, World Trade Organisation (WTO)Paul Ranson, of global law firm Morgan Lewis’ London Life Science’s Practice, examines how the UK Biopharma must now adapt to a changing landscape.
Incentives, Opportunities Abound as Orphan Drug Demand Grows
Biopharma, Bones, Breakthrough Therapy Designation, CDC, Congress, Department of Health and Human Services (HHS), EMA, Enzyme Replacement, EU, FDA, FDA/Regulatory, glioblastoma Multiforme (GBM) Brain Cancer, Hypophosphatasia (HPP), June 2017, Metabolic Disorders, Orphan Drug Act, Rare DiseasesConcerted effort by governments, regulators, and industry is rapidly expanding development of new therapies for the more than 7,000 known rare diseases.
Join TrialScope’s Chief Strategy Officer, Thomas Wicks and Senior Product Specialist, Matt DeFranco, for a timely discussion of how life sciences teams can prepare for these changing requirements.
LAVAL, QUEBEC–(Marketwired – Aug. 4, 2015) – ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), (“ProMetic” or the “Corporation”) announced today that an orphan drug designation status has been granted for its human […]
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for […]