The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.

The negotiations for the next device user fee agreement are well underway, and there are signs that the FDA is looking for a significant boost in user fees from device makers. However, Rep. Anna Eshoo (D-Calif.) told members of the MDMA that no member of Congress should believe that user fees relieve Congress of its responsibility “for funding the agency in a robust way.”

Twenty years after the first, exclusively white human genomes were fully sequenced, science finds itself in the same position as the rest of society: with the uncomfortable realization that old inequalities are often morphing, rather than disappearing. Vocal racists – scientists of the stripe of a James Watson – are by no means a thing of the past. But they are only the tip of the iceberg.

Insulet Corp. reported positive results from a pivotal trial of its Omnipod 5 automated insulin delivery system for patients with type 1 diabetes. The tubeless, wearable insulin delivery system lowered hemoglobin A1c (HbA1c) – a critical diabetes measure – in children, adolescents, and adults, and improved the time that patients were in the target blood glucose range. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting, which was held virtually this year.

The first day of the annual meeting of the American Clinical Laboratory Association (ACLA) included a brief address by two members of Congress, including Rep. Brett Guthrie (R-Ky.), who chairs the health subcommittee of the House Energy and Commerce Committee. Guthrie acknowledged that the reset of the Medicare clinical lab fee schedule was not going as intended, but declined to identify any possible fixes pending a report by the Medicare Payment Advisory Commission.

KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined. And after 40 years, they look to be getting a targeted therapy, or even two.

What is the outlook for investment in digital health over the coming year? A group of investment experts tackled that question during a session of the Digital Medicine & Medtech Showcase, which is being held virtually this week. Although COVID-19 was disruptive, there was a huge increase in health innovation investment last year, with a jump of roughly 56%, said Logan Plaster, director and editor-in-chief at Startup Health.

HONG KONG – Partnerships are reshaping the pharmaceutical industry across Asia, said speakers during day two of the Phar-East 2020 virtual conference. While industry has “tended to have a go-at-it-alone approach,” doing all its discovery, development and commercialization work in-house, “nothing ever came in or out. I think that’s really changed in recent years,” said Kazia Therapeutics Ltd. CEO James Garner.

Under the right circumstances, a single mouse can be as good as a group of eight or 10 animals in predicting whether a tumor will respond to a drug, researchers reported at the 2020 EORTC-NCI-AACR (ENA) Molecular Targets meeting on Saturday. The single-animal approach “allows incorporation of more tumor models within the same resource constraints,” Peter Houghton told reporters at a press conference previewing ENA highlights.