Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
The U.S. FDA is keen on developing policies to guide testing regimes for future pandemics based on the experience with COVID-19, and the FDA’s Tim Stenzel said on a Sept. 8 advisory hearing that automated reporting of at-home tests would clarify questions such as the spread of the pathogen and how well the tests are performing. Stenzel, who is the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said the U.S. government agencies have made a number of grants for development of automated reporting mechanisms for at-home tests, signaling an interest on the FDA’s part that automated reporting capabilities will be a priority when the next pandemic strikes.
Limaca Medical Ltd. received U.S. FDA 510(k) clearance for its Precision for gastrointestinal (GI) endoscopic ultrasound (EUS) biopsy device which the company said allows for faster, more efficient and safer collection of tumor tissue samples. The approval follows the receipt of breakthrough device designation, and the deployment of the device into the U.S. market should lead to more efficient and effective diagnosis of GI cancers.
Eikon Therapeutics Inc. has received IND clearance from the FDA to initiate phase I studies with IMP-1734, a highly selective poly(ADP-ribose) polymerase 1 (PARP-1) inhibitor developed in partnership with Impact Therapeutics Inc.
With the U.S. FDA’s approval of Biolinerx Ltd.’s stem cell mobilization agent Aphexda (motixafortide) for treating multiple myeloma (MM) patients, the company is prepping for a launch in the next two or three weeks.
In a potential breakthrough for diagnosis and treatment development of liver disease, the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project demonstrated that a blood test could diagnose nonalcoholic steatohepatitis (NASH), an increasingly common liver disease in the U.S. The study, published in Nature Medicine, identified four biomarkers that outperform current liquid biopsies for NASH.
Direct-to-consumer advertising (DTC) for medical devices does not present the same policy footprint as DTC ads for drugs, but Congress recently asked the U.S. Government Accountability Office (GAO) to investigate device advertising to evaluate whether reforms are needed. GAO responded to the effect that while the literature lacks any useful studies on the question, some stakeholders believe that DTC device ads give short shrift to risk information, a finding that may prompt Congress to enact new legislation on the question.
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has jumped on board the e-consent train for clinical trials, publishing a guidance for the use of electronic means for obtaining a study participant’s informed consent.
Amsterdam-based Royal Philips NV reported that it has come to terms with customers and end users of its respiratory equipment to the tune of $479 million, which will reimburse for the cost of these systems. The problem for the company is that the settlement does not affect any personal injury cases, and thus represents only a partial closure of a controversy that has dogged the company for several years.