Regulatory Affairs
The US Food and Drug Administration (FDA) has released updated guidance on COVID-19 diagnostic and serology testing, signaling its intention to review fewer emergency use authorizations (EUAs) for new tests moving forward.
Posted: September 27, 2022, 8:47 pm
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Common Rule, which contains requirements for protection of human subjects in research conducted or supported by the US Department of Health and Human Services.
Posted: September 27, 2022, 8:45 pm
Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License Applications (BLA) for Real-Time Oncology Review (RTOR) want more clarity on how the guidance applies to cell and gene therapies and have asked the agency to align the draft guidance with what appears on the RTOR website.
Posted: September 27, 2022, 7:34 pm
Lawmakers have struck an eleventh-hour deal to renew the US Food and Drug Administration’s (FDA) user fee programs. With just four days to go before the current programs expire, Democrats conceded to Republican demands for a “clean” reauthorization package without major riders, including diagnostics reform.
Posted: September 27, 2022, 6:48 pm
Australia is holding a consultation on whether to allow advertisers to make references to the Therapeutic Goods Administration (TGA) in their promotional materials. TGA is seeking feedback on a wide range of options, from maintaining the current prohibition through to different, more permissive approaches.
Posted: September 27, 2022, 5:19 pm
Biotechnology
Element Biosciences, Inc. announced updated specifications to their AVITI System, increasing the platform's specifications from 800 million reads per flow cell to 1.0 billion reads per flow cell*, further reducing the price per Gigabase.
Posted: September 27, 2022, 12:00 am
Novavax, Inc. today announced that an initial one million doses of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine are now available for use in the United Kingdom (U.K.).
Posted: September 27, 2022, 12:00 am
The FDA ordered Avidity Biosciences to halt clinical trial enrollment after a patient suffered a "serious adverse event" testing the company's candidate drug for myotonic dystrophy type 1.
Posted: September 27, 2022, 12:00 am
Abivax SA announces today that its abstract on the obefazimod interim 48-week safety and efficacy analysis from the ongoing open-label phase 2b maintenance study in moderate to severe ulcerative colitis (UC) has been selected as "one of the best abstracts" for UEG (United European Gastroenterology) Week 2022.
Posted: September 27, 2022, 12:00 am
Akari Therapeutics, Plc today announced financial results for the quarter ended June 30, 2022, as well as pre-clinical and clinical progress on nomacopan and long-acting PAS-nomacopan.
Posted: September 27, 2022, 12:00 am
Pharmaceuticals
An investigational Alzheimer’s disease treatment from Biogen and Eisai slowed the rate of cognitive decline by 27% in a clinical trial, the companies said Tuesday, meeting the goals of a…
Posted: September 27, 2022, 11:30 pm
In new guidance, the FDA specified that AI tools designed to warn providers about sepsis should come under regulatory review. Health software vendors have been selling such tools for years…
Posted: September 27, 2022, 8:50 pm
In the latest edition of STAT Health Tech: Google's hospital play, Optum’s data shakeup, & the call for more telehealth oversight.
Posted: September 27, 2022, 8:00 pm
A top digital health official at the FDA said the agency's approach to reviewing updates for digital health products is too slow for companies and consumers.
Posted: September 27, 2022, 6:32 pm
A new study sees a possible link between aluminum in childhood vaccines and risk of asthma, but caveats abound.
Posted: September 27, 2022, 3:01 pm
Human Resources
The move comes as health systems are increasingly concerned about burnout amid the talent shortage.
Posted: September 27, 2022, 8:04 pm
Studies show that the tech sector lacks qualified talent equipped to work with artificial intelligence and machine learning.
Posted: September 27, 2022, 3:18 pm
The study comes at a time in which external forces have created significant barriers for women’s career trajectories.
Posted: September 27, 2022, 2:11 pm
Employers are still wary of turning away from degree-based hiring, reports have said, which is the first step for truly skills-first organizations.
Posted: September 27, 2022, 1:53 pm
Flexibility remains a top perk for employees — and is increasingly becoming table stakes.
Posted: September 26, 2022, 9:05 pm