Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.

The U.S. Federal Trade Commission has posted notice to health care companies that their use of noncompete agreements for physicians and nurses may violate the law. The advisory may allow physicians and nurses engaged in clinical trials to move to other employers, thus complicating the conduct of those trials.

Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.

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.

Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.

Rona Therapeutics Co. Ltd. has announced an IND filing with the Australian Human Research Ethics Committee (HREC) for RN-3161 for obesity. RN-3161, a novel siRNA developed through Rona’s proprietary GAIA platform, targets INHBE to reduce fat while preserving lean mass.

The draft Medicare physician fee schedule (MPFS) for 2026 proposed to treat skin substitutes as incident-to supplies in the related procedures, but the blowback was pronounced and vigorous, with London-based Convatec plc arguing that the agency lacks the statutory authority to make such a change.

The first phase of the EU’s Data Act is now officially in place, although member state enforcement of the Act might be spotty. This is because several nations, including Germany, have yet to finalize implementing regulations for the Data Act, a problem these nations will have to fix as the secondary and tertiary compliance dates arrive in August 2026 and August 2027.

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.