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Recon: GSK will pull blood cancer drug from US market following study setback; Teva, AbbVie finalize $6.6B US opioid settlements
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Jazz plays coda to blood cancer approval, securing FDA nod for revised dosing schedule (Fierce) ( FDA)
Palisade Bio is Granted Fast Track Designation from the U.S. Food and Drug Administration for LB1148 for Accelerated Return of Bowel Function following GI Surgery (Biospace)
Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes (Scrip) (STAT) (Endpoints)
Biden forges new $475M campaign to drive uptake of Pfizer and Moderna's bivalent Covid vaccines (Endpoints)
AI Screening System For Blindness Associated With Diabetes Gets FDA Nod (MedTech Insight)
H2o Therapeutics makes a splash with FDA nod for Parkinson’s-monitoring Apple Watch app (Fierce)
Common Specifications: An Antidote To MDR’s Clinical Evidence ‘Moveable Feast’? (MedTech Insight)
Medtronic cuts annual profit forecast blaming strong dollar (Reuters)
Teleflex plans layoffs amid restructuring plan costing up to $40M (Fierce)
AI-powered blood test detects liver cancer, opening opportunity to improve screening (MedTech Dive)
Government, Regulatory & Legal
Teva, AbbVie finalize $6.6 billion U.S. opioid settlements (Reuters)
Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims (Pink Sheet) (Endpoints)
Anti-abortion groups file suit against FDA in Texas, demands agency revoke approval for abortion pill (Endpoints)
J&J’s DePuy Beats Bid for Pre-Trial Ruling on Spinal-Fusion Tech (Bloomberg)
Drug Salesman’s Convictions Vacated Over Biased Verdict Form (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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.