A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Pfizer announced positive results from two Phase III trials, one in moderate-to-severe atopic dermatitis and another in pneumococcal disease.
The Dupixent product developed by Sanofi and the French company’s U.S. partner Regeneron won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents.
Sanofi Reports Strong Second-Quarter 2019
Acquisitions, Analysts, Asthma, Atopic Dermatitis (Eczema), Business, China, Chronic Rhinosinusitis, Diabetes, Earnings per share (EPS), European Medicines Agency, FDA, Future Blockbusters, Hemophilia, Insulin, Product Launches, Profitability, Quarterly results, R&D, Relapse/Refractory Multiple Myeloma, VaccinesSanofi reported overall net sales increased by 5.5 percent for second-quarter 2019, driven by Sanofi Genzyme, Sanofi Pasteur and emerging markets.
FDA approves expanded label for Regeneron/Sanofi’s Dupixent
Analysts, Approvals, Asthma, Atopic Dermatitis (Eczema), Biologics, Blockbusters, Chronic Obstructive Pulmonary Disease (COPD), Chronic Rhinosinusitis, Corticosteroids, Environmental Allergies, Eosinophilic Esophagitis, Expanded Label, FDA, FDA/Regulatory, Food Allergies, Nasal PolypsThe U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.
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.
The U.S. Food and Drug Administration accepted for priority review the license application for the use of Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis
Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.
Sanofi will continue to implement cost savings after having reached a 1.5 billion euros ($1.75 billion) cost reduction target a year ahead of expectations, while several of the company’s key drugs are selling well.
Shares of Realm Therapeutics plunged more than 50 percent after the company’s Phase II atopic dermatitis drug failed to distinguish itself from the control arm in the study.