Drug regulators around the world have a unique opportunity – and, in some cases, a legal mandate – to remove the taint of forced labor from the biopharma supply chain. But some of them, including the U.S. FDA and Japan’s PMDA, may be turning a blind eye to those responsibilities, according to a recent report from the nonprofit Centers for Advanced Defense Studies.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) set up its second overseas regulatory office in Washington, four months after the drug and med-tech regulator opened its first Asia base in Bangkok, Thailand, in July 2024.
Astrazeneca plc’s China president, Leon Wang, is under investigation in mainland China, the company said in an Oct. 30 statement. Although details are scant, Astrazeneca said Wang is “cooperating with an ongoing investigation by Chinese authorities,” and the company’s China operations will continue under the leadership of the current general manager of Astrazeneca China.
Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.
Medicare coverage of digital mental health therapies has traditionally been lacking, but the final Medicare physician fee schedule for 2025 added three new codes to deal with the coverage gap.
While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service.
Hifibio Therapeutics Inc. has gained IND clearance from the FDA for HFB-200604, a potentially best-in-class BTLA agonist monoclonal antibody for inflammatory and immunology diseases.
Damona Pharmaceuticals Inc. has obtained IND clearance from the FDA for DPX-101 for the treatment of cognitive deficits in brain disorders, including major depressive disorder.
Korro Bio Inc. has announced a submission to the Australian Bellberry Human Research Ethics Committee (HREC) for a phase I/II study of KRRO-110 for α-1 antitrypsin deficiency (AATD).
Disc Medicine Inc. found itself after an end-of-phase II meeting with the U.S. FDA in what Wainwright analyst Douglas Tsao called a “best-case scenario” regarding the path forward for bitopertin in erythropoietic protoporphyria (EPP).
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