Pharmaceutical companies in China will cut the prices for more than five dozen drugs by an average of 61.7% to get them on the latest version of the country’s National Drug Reimbursement List. The National Healthcare Security Administration released the new list on Dec. 3, 2021. The new list includes 74 new drugs, the vast majority of which are branded products without generic versions in China. Only seven of the new drugs on the list have generic versions.
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.
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