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EU food agency sets 'safe' consumption level for hemp-derived CBD (Reuters)
Pharma & Biotech
Biotech doubles financing in quest to silence genes behind neurological diseases (STAT)
Eli Lilly to buy Orna Therapeutics for $2.4 billion (STAT)
Takeda deepens AI drug discovery push with $1.7 billion Iambic deal (Reuters)
Lilly Inks Deal with Innovent to Speed Up Early Drug Development (Bloomberg)
Lilly likens relentless work of scientific and athletic progress in Winter Olympics ad (Fierce Pharma)
Roche’s Genentech cut at least 489 jobs last year, new disclosure reveals (Fierce Pharma)
Biogen pins SMA recovery on high-dose Spinraza amid projected 2026 revenue slump (Fierce Pharma)
Medtech
Abbott Says Plans To Launch Dual Diabetes Sensor Unimpeded By Latest Warning Letter (MedTech Insight)
Boston Scientific Sees EP Growth Exceeding Market Despite PFA Competition (MedTech Insight)
Boston Scientific Says Penumbra Deal Could Lift Market Growth Profile As 10%+ Organic Target Holds (MedTech Insight)
Bundling Approach Brings $382M Antitrust Verdict Against Medtronic (MedTech Insight)
Food & Nutrition
Texas plant-based meat labeling law struck down by court (Food Dive)
Congresswoman says promises are not enough to allow Boar's Head to reopen facility (Food Safety News)
Government, Regulatory & Legal
Federal government turns to fresher data to rein in Medicare Advantage upcoding (STAT)
As a scientist and NFL widow, I am furious about a recent NFL Players Association-funded CTE study (STAT)
Faster FDA Reviews Cut Red Tape, But Critics Wonder at What Cost (Bloomberg)
Sixth Circuit Affirms Steep Sentence in FDC Act Counterfeiting Case (FDA Law Blog)
Following legal setbacks, HHS agrees to toss 340B Rebate Model Pilot Program (Fierce Pharma)
Citizen Pazdur: Former US FDA Oncology Head Still Interested In Drug Development (Pink Sheet)
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.