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Boehringer's bispecific pact with Cue Biopharma; HepaRegeniX raises €21.5M (Endpoints)
Medtech
Tariffs top of mind for medtech firms this earnings season (MedTech Dive)
Late-stage digital health funding rebounds in Q1: Rock Health (MedTech Dive)
Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark (MedTech Insight)
MedStar Teams Up With Reimagine Care To Extend Cancer Care Into Patients’ Home (MedTech Insight)
Dexcom Promotes CGM As First-Line Tool In Type 2 Diabetes (MedTech Insight)
Gleamer Charts Multi-Modality Future With FDA Nod And MRI Acquisitions (MedTech Insight)
Unlocking Potential: Could EU’s New Surgical Centers Drive Demand For Advanced Medtech? (MedTech Insight)
Food & Nutrition
Food manufacturers rethink innovation to keep up with rapidly-changing consumer demands (Food Dive)
Lab-Confirmed Cases of Salmonella, Campylobacter Infections in England Increased in 2023 (Food Safety)
USDA-FSIS Delays Salmonella Verification Sampling of NRTE Breaded, Stuffed Chicken Products by Six Months (Food Safety)
Government, Regulatory & Legal
Fired FDA communications staff worry about impact on public health (Roll Call)
The NIH called my health equity research ‘antithetical to scientific inquiry’ (STAT)
US House committee seeks testimony from 23andMe co-founder after bankruptcy (Reuters)
An interview with Christi Grimm, and ‘existential’ upheaval at HHS (STAT)
Universities begin search for indirect-cost fix that might assuage Trump administration (STAT)
ASCA 2024 Performance Update: Can ASCA Improve Submission Predictability? (FDA Law Blog)
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.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.