AstraZeneca Plc’s Imfinzi was approved in the European Union to treat an aggressive form of lung cancer in previously untreated adult patients.
Top 10 Pipelines To Watch
Acquisitions, Analysts, Annual Reports, Blockbuster Deals, Blockbusters, Business, Clinical Trials, Deals, Dengue, Department of Health and Human Services (HHS), Dermatology, Diffuse Large B-Cell Lymphoma (DLBCL), EMA, European Commission, European Medicines Agency (EMA), FDA, FDA/Regulatory, February 2020, Future Blockbusters, Hemophilia A, Hospital-Acquired Bacterial Pneumonia, Issue Archives, Licensing, Natural Killer Cells (NK Cells), New Drug Applications, New Molecular Entities, NMEs, Oncology, Potential Blockbusters, Priority Review, Priority Review Status, Product Pipelines, R&D, Rare Diseases, Senate Panel, Special Reports, Top 10 Pipelines, Top 10 Pipelines To Watch, VaccinesAs pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
Zogenix Reports Positive Results from Phase III Trial of Rare Childhood Epilepsy Study
Children, Clinical Data, Clinical Trials, Dravet syndrome, European Commission, European Medicines Agency (EMA), FDA, FDA/Regulatory, Lennox-Gastaut Syndrome (LGS), New Drug Application (NDA), Orphan Drug Designation, Orphan Drug Designation, Priority Review, R&DEmeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
Bristol-Myers Squibb Withdraws European Application of Opdivo Plus Yervoy for First-Line Treatment of Advanced NSCLC
Blockbusters, Checkpoint Inhibitors, Committee for Medicinal Products for Human Use (CHMP), European Commission, FDA, FDA/Regulatory, PD-1/PD-L1 inhibitors, Priority Review, Withdrawn ApplicationBristol-Myers Squibb withdrew the company’s application in the European Union for the combination of Opdivo and Yervoy for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.
Bayer won an endorsement from the European Union’s drug regulator for the company’s prostate cancer drug darolutamide, putting the medicine on track for approval to take on rival products from Pfizer and Johnson & Johnson.
European drug panel recommends approving Novo Nordisk’s new diabetes pill
Blockbusters, Committee for Medicinal Products for Human Use (CHMP), Diabetes, European Commission, European Medicines Agency (EMA), FDA/Regulatory, First-of-its kind, Glucagon-Like Peptide-1 (GLP-1) Analogs, Injectables, Recommended For Approval, Type 2 DiabetesA panel of the European medicines regulator recommended approving Novo Nordisk’s new diabetes pill Rybelsus, further boosting prospects for the Danish drugmaker with the company’s first-of-a-kind, non-injectable treatment.
BioSpace Global Roundup: Jan. 30, 2020
Alopecia, Anti-GBM Antibody Disease (Goodpasture´s Disease), Approvals, Bacteria, Business, Cancer, Clinical Trials, Deals, Diagnostics, Drug Discovery, European Commission, FDA/Regulatory, Hair Loss, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), New Indications, PD-1/PD-L1 inhibitors, Product Pipelines, R&D, TumorsPharma companies from across the globe provide updates on their pipelines and business.
The U.S. Food and Drug Administration approved drugmaker Merck & Co.’s Ebola vaccine Ervebo, the first FDA-authorized vaccine against the deadly virus.
The European Commission granted marketing authorization to Amgen and UCB for Evenity (romosozumab) for treating severe osteoporosis in postmenopausal women at high risk of fracture.
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.