Gilead, Arcus’ PhII gastroesophageal cancer data argue for TIGIT antibody drug class potential (Endpoints)
Medtech
Remote patient monitoring helped manage hypertension better, but at a higher cost (STAT)
A fertility clinic failure destroyed my chance at motherhood (STAT)
The PATCH Act’s approach to securing medical devices actually gives malicious actors a blueprint (STAT)
Zimmer Biomet’s Ivan Tornos sets priorities for first year as CEO (MedTech Dive)
Diabetes tech firms focusing on Type 2 patients (MedTech Dive)
Government, Regulatory & Legal
California Low-Cost Insulin Faces Delays After Price-Cap Veto (Bloomberg Law)
FTC’s Lina Khan makes a stop at Y Combinator, how telehealth helps rural America (STAT)
Government looks to tinker with new caps on Medicare Advantage broker payments (STAT)
US FTC disputes listing for more than 100 patents in FDA Orange Book (Reuters)
US CDC to expand surveillance of traveler samples for respiratory viruses (Reuters)
Pfizer gathers Covid campaign 'icons' Martha Stewart, John Legend, Travis Kelce and more for latest booster push (Endpoints)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices.