South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
Just three days before the U.S. CDC’s reconstituted Advisory Committee for Immunization Practices (ACIP) is scheduled to discuss and possibly vote on the COVID-19, hepatitis B and MMRV vaccines, Health and Human Services Secretary Robert Kennedy added five new members to the panel.
Two months after it was launched, the wheels are coming off the U.K. government’s 10-year life sciences strategy, with pharma companies withholding promised capital investments in protest at the row over drug pricing. Merck & Co. Inc., Astrazeneca plc and Eli Lilly and Co. Inc. have said they are not going ahead with previously announced investments.
CSPC Pharmaceutical Group Ltd.’s SYH-2066 tablets has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials for respiratory infections caused by respiratory syncytial virus (RSV).
Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
The American Medical Association has posted the latest update to the current procedural terminology code set, which deletes more than 80 existing codes and adds nearly 290 new codes. Among the new codes are several for AI-assisted device services and several tweaks to codes for peripheral artery diseases, presenting a new batch of opportunities for device makers to obtain Medicare coverage for their offerings.
Arrowhead Pharmaceuticals Inc. has filed a request for regulatory clearance in New Zealand to initiate a phase I/IIa trial of ARO-MAPT, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for tauopathies, including Alzheimer’s disease.
Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
When it won U.S. FDA accelerated approval more than eight years ago, Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) was viewed as a breakthrough, becoming the first new treatment in 20 years for rare, progressive liver disease primary biliary cholangitis (PBC) and, for several years, the only second-line treatment for PBC patients failing to respond to ursodeoxycholic acid. More recently, however, Ocaliva has faced regulatory and safety stumbles, with Intercept now voluntarily pulling the farnesoid X receptor activator from the U.S. market.
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