Diopsys Inc. agreed to pay $14.25 million to settle allegations it violated the False Claims Act (FCA) in encouraging the unnecessary use of the company’s Nova device for retinal testing.

China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released by China’s National Medical Products Administration.

The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures.

Mehmet Oz won the U.S. Senate’s nod as the administrator of the Centers for Medicare & Medicaid Services. Oz brought in 53 aye votes to 45 nays in the Senate’s April 3 confirmation tally, and inherits a complicated task as the Medicare breakthrough devices coverage program continues to face substantial challenges.

Biomedical research seems like it should be the ultimate bipartisan issue. But under the Trump administration, unless and until Congress regains its will to make use of its constitutional powers, bipartisan support for research seems to be a thing of the past.

Biomedical research seems like it should be the ultimate bipartisan issue. But under the Trump administration, unless and until Congress regains its will to make use of its constitutional powers, bipartisan support for research seems to be a thing of the past. On March 3, members of the National Academies of Science, Engineering and Medicine warned that the second Trump administration has been waging a “wholesale assault” on American research.

Resvita Bio Inc.’s RVB-003 has been awarded orphan drug designation by the FDA for the skin disorder Netherton syndrome. RVB-003 was previously granted rare pediatric disease designation.

The U.S. FDA cleared Artrya Ltd.’s Salix Coronary Anatomy software that analyzes coronary computed tomography angiogram scans via AI to better diagnose coronary artery disease.

President Donald Trump’s executive order on global tariffs have pushed downward the stocks of biopharma and med-tech companies, even though the impacts of his 10% baseline tariff – which excludes pharmaceuticals – and his reciprocal tariffs affecting about 60 countries across the globe, are still unclear. “The story for the day is there’s still a lot of uncertainties in terms of pharmaceuticals,” said Wayne Winegarden, senior fellow and director of the Center for Medical Economics and Innovation at the Pacific Research Institute, a free-market think tank. “It’s going to pressure margins, pressure availability. This is just a complete negative for the industry. It’s self-inflicted. It’s not just unnecessary, it’s unwarranted.”