Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caldera Medical.
The rise of large national health care systems, mainly in Europe, has created an ongoing tension with the free market ethos of the pharma industry. After years of painstaking and costly research, drug makers want that moment when they can reap the rewards for their hard work bringing an innovative new therapy to the market. But in countries in Europe and beyond where there are national health care systems with stringent cost constraints, it’s not feasible to meet these price demands, at least without some form of rationing to keep down expenditure.
Longeveron Inc.’s share price (NASDAQ:LGVN) jumped 11.7% on Dec. 3 after the FDA awarded orphan designation to Lomecel-B, allogeneic bone marrow-derived mesenchymal stem cells, for treating hypoplastic left heart syndrome. The designation came two weeks after the FDA granted rare pediatric disease designation for Lomecel-B to treat the life-threatening congenital heart defect in infants.
Usama Malik, Immunomedics Inc.’s former chief financial officer, and his former partner, Lauren Wood, face SEC charges related to insider trading in Immunomedics’ stock.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Adrenomed, Amgen, Chemomab, Chiesi, CNS, Dyne, Helsinn, Italfarmaco, Interna, J&J, Medexus, Mingmed, Tot, Tryp.
PERTH, Australia – The FDA has cleared Immunexpress Inc.’s 510(k) for its Septicyte rapid diagnostic test for sepsis that quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis. The test uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Active Life Scientific, Amra Medical, Qiagen.
The U.S. Court of Appeals for the Federal Circuit struck a blow Nov. 30 to Biogen Inc.’s blockbuster multiple sclerosis (MS) drug, Tecfidera, affirming a lower court’s determination that a patent claiming a method of treating MS was invalid for lack of written description. In two other precedential cases the next day, the appellate court opened the door for Arbutus Biopharma Corp. to seek royalties on Moderna Inc.’s COVID-19 vaccine.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023.