The New York Times published an article on Aug. 20 about potential conflicts of interest on the part of Jeff Shuren, former director of the Center for Devices & Radiological Health (CDRH), arguing that Shuren may have failed to recuse himself in matters in which his wife, a regulatory attorney, represented a medical device maker.

The U.S. Government Accountability Office’s report on FDA oversight of medical devices acknowledges that the agency has made strides in its efforts to develop surveillance systems to track adverse events, but there are shortcomings.

Despite the U.S. FDA’s tentative approval of Liquidia Corp.’s Yutrepia (treprostinil) for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, the company is stuck in the starting gate. Liquidia said it disagrees with the agency’s stance of simultaneously granting regulatory exclusivity in both indications to United Therapeutics Corp.’s powdered formulation of treprostinil, branded Tyvaso, until May 23, 2025. That means full approval for the inhalation powder won’t come until after that date and neither will a Yutrepia launch.

Pfizer Inc. is calling on the Australian government to establish priorities for the life sciences sector to attract more investment into research, clinical trials and manufacturing in Australia. The new report recommends that the government issue a life sciences vision akin to the one issued by the U.K. in 2021 to make the country more competitive to attract investment.

The COVID-19 pandemic drove a large volume of in vitro diagnostic test efforts toward the SARS-CoV-2 virus, such as the Biofire respiratory panel by Biofire Diagnostics LLC, of Salt Lake City, a test for which the U.S. FDA released the special controls.

Privacy legislation was passed and implemented in the European Union, but the picture in the U.S. is pockmarked by state legislation, a scenario that raises concerns about a fractured and impracticable compliance regime.

Innovec Pharmaceutical Technology Co. Ltd. (Innovec Biotherapeutics) has received FDA clearance for its IND application for IVB-103, an AAV-based gene therapy for neovascular age-related macular degeneration (AMD).

Immunesensor Therapeutics Inc. has received Human Research Ethics Committee (HREC) approval and clinical trial notification (CTN) clearance by Australia’s Therapeutic Goods Administration (TGA) to initiate a phase I study of IMSB-301, a novel, orally available small-molecule cGAS inhibitor that is being developed for the treatment of inflammatory and autoimmune diseases.

Label comparisons began promptly with the accelerated U.S. FDA clearance of Gilead Sciences Inc.’s oral peroxisome proliferator-activated receptor (PPAR)-delta drug, Livdelzi (seladelpar), for primary biliary cholangitis (PBC). The space includes Ipsen Pharma SA’s dual PPAR alpha/delta agonist, Iqirvo (elafibranor), licensed from Genfit SA and cleared in June 2024, as well as Ocaliva (obeticholic acid), the first-in-class farnesoid X receptor agonist from Intercept Pharmaceuticals Inc., greenlighted for PBC in May 2016.