Amgen Inc. reported that third-quarter 2020 adjusted profit rose 17% due to stronger sales of drugs such as the osteoporosis treatment Prolia and the psoriasis medication Otezla, bucking challenges from lower drug prices and Covid-19.
France’s Genfit announced significant restructuring that will include cutting 40 percent of the company’s staff.
FDA Action Alert: Aquestive, Eton and Mesoblast
Adrenal Glands, Adrenal Insufficiency, Business, Clinical Trials, Congenital Adrenal Hyperplasia (CAH), Epilepsy, FDA/Regulatory, Glands, New Drug Application (NDA), Oncologic Drugs Advisory Committee (ODAC), PDUFA, Pediatric, Quarterly results, R&D, Seizure ClustersThe U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida
Adeno-Associated Virus (AAV), B Cell Lymphomas, Biologics License Application (BLA), Brain Metastases, CAR-T Therapy, Chronic Kidney Disease, Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Hemophilia A, HER2-positive breast cancer, Immunotherapy, New Drug Applicationa, Project Orbis, Quarterly results, T-CellsThe U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
South San Francisco-based Unity Biotechnology reported that the 12-week results from the company’s Phase II study of UBX0101 in moderate-to-severe painful osteoarthritis (OA) of the knee failed to show improvement over placebo.
San Diego-based Ligand Pharmaceuticals is acquiring San Diego-based Pfenex for a total deal transaction of up to $516 million.
Alexion Pharmaceuticals shuttered the company’s oral small molecule Factor D inhibitor program for a rare kidney disease following disappointing clinical data.
British drugmaker AstraZeneca topped second-quarter sales and profit estimates and backed the company’s 2020 forecasts, helped by strong sales in lockdowns of a diverse product range that includes a potential coronavirus vaccine.
The U.S. Environmental Protection Agency (EPA) approved use of UK-based Reckitt Benckiser’s Lysol Disinfectant Spray against COVID-19.
In a move aimed at boosting efficiency in drug development, Sangamo Therapeutics split the company’s research and development teams into two separate units.