China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
If a bipartisan group of U.S. House members has its way, at least some of the legislation congressional committees have passed to target pharmacy benefit manager (PBM) practices could yet make it into law this year. That is if congressional leaders listen to the rank-and-file members.
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies compared to natural history external control are muscular enough to get the process going without having to dive into additional studies.
In a surprise move that drove its stock up by 292% in early trading, Chimerix Inc. revealed plans for a U.S. NDA filing by year-end, seeking accelerated approval of dordaviprone (ONC-201) to treat recurrent H3 K27M-mutant diffuse glioma, a highly aggressive tumor with limited treatment options.
The Biosecure Act missed its expected ride through the U.S. Congress via the National Defense Authorization Act, but it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed “biotechnology companies of concern.”
The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others.
Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry.
Base Therapeutics (Shanghai) Co. Ltd.’s NK-510 cell injection, a zero-off-target base-edited natural killer (NK) cell product, has received approvals to start clinical trials from both the U.S. FDA and China’s NMPA for clinical trials for advanced solid tumors.
RSS
