BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors, two weeks after Novartis AG’s alpelisib, which aims at the same target, was also granted IND clearance in China.
The acceptance by the FDA of Prevail Therapeutics Inc.’s IND for the one-time, fast-tracked gene therapy PR-006 provided hope for 50,000 to 60,000 people in the U.S beset by frontotemporal dementia with the GRN mutation (FTD-GRN), and the New York-based company is moving ahead with a phase I/II experiment called Proclaim.
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax (nitric oxide) inhaled gas to treat COVID-19-associated lung complications. INOmax is marketed in the U.S. by the Staines-upon-Thames, U.K.-based company to treat full- and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
BEIJING – China has finally written all its drug-related reforms into law, as it passed the amendment of its drug administration law in late August, the amendment to take effect on Dec. 1. Those moves carry one goal: to bring more and better drugs into the Chinese market as quickly as possible.
What if we paid professional athletes only when they won? What if spectators got their tickets refunded whenever the home team lost? That might make that $1,300 Super Bowl ticket a little easier to purchase. And, hey, perhaps that might assuage some of the crushing disappointment for Denver fans still bemoaning the Broncos’ embarrassing defeat. (Though, on second thought, maybe not. Broncos’ fans are pretty passionate and hard core.) But along those same lines, what if we paid for therapeutics only when they worked? That would keep the cost of health care from further spiraling out of control, right? That...
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