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How do we know mRNA vaccines are safe and effective? An explainer (STAT)
The new era of individualized medicine requires a ‘genetic surgery’ system (STAT)
Sanofi makes $470M move for Vigil's Alzheimer's drug, while another asset returns to Amgen (Endpoints)
Samsung Biologics to separate manufacturing and biosimilar businesses (Endpoints)
Samsung Biologics, C&T Shares Volatile After Spin-Off Plan (Bloomberg)
FDA asks Covid vaccine makers to add more myocarditis data to labels (Endpoints)
Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor (Pink Sheet)
US CDC accepts recommendations for chikungunya vaccines (Reuters)
Medtech
ASCO and Google create ‘walled garden’ AI tool for doctors to query group’s guidelines (STAT)
Self-guided mental health apps can improve outcomes and lower costs, report finds (STAT)
Hinge Health is going public on Thursday at a $3B valuation (Endpoints)
AI-Generated Drugs to Reach Market by 2030, Says Insilico CEO (Bloomberg)
Cost cuts, production shifts: How medtech firms are managing tariffs (MedTech Dive)
Why Medtronic plans to spin out its diabetes business (MedTech Dive)
Food & Nutrition
Three big ideas to actually ‘Make America Healthy Again’ (STAT)
Kraft Heinz confirms $3B investment in US manufacturing (Food Dive)
Food industry fights for SNAP as program faces massive cuts (Food Dive)
Study: AI Can Predict Listeria Resistance to Cleaning Agents (Food Safety)
Government, Regulatory & Legal
Trump, building on Biden policy, to speed up audits of Medicare Advantage insurers (STAT)
LGBTQ+ researchers sue HHS, NIH over grant cuts (STAT)
Trump’s R&D Funding Cuts Create Job Drought for Scientists (Bloomberg)
One Analyst Saw the Dark Clouds Coming for UnitedHealth (Bloomberg)
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.