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Recon: FDA misses PDUFA goal date for Agios' thalassemia therapy; Mirum to buy Bluejay for up to $820M
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
NIH shut out hundreds of young scientists from funding to start their own labs (STAT)
Driven by GLP-1s, prescription drug spending explodes at major health insurers (STAT)
FDA misses PDUFA review deadline for Agios' thalassemia drug (Endpoints)
Kennedy's advisers scrap hepatitis B vaccine guidance for most children in major policy shift (Reuters)
Why Bill Gates Thinks Donald Trump Cares About Global Health (Bloomberg)
In Focus: International
Congo battles worst cholera outbreak in 25 years, UNICEF says (Reuters)
Eli Lilly's Mounjaro added to China's state insurance list for diabetes treatment (Reuters)
Global leaders commit $1.9 billion to eradicate polio amid funding cuts (Reuters)
Chinese Biotech, Investments Are on Track to Face New US Curbs (Endpoints)
Carlyle Group Is Said to Lead Bidding for Japan’s Hogy Medical (Bloomberg)
NICE Rules-Based Pathway Tops Conference Talking Points For UK Healthtechs (MedTech Insight)
EU Targets Faster, Predictable Multinational Clinical Trial Reviews (Pink Sheet)
UK-US Trade Deal: How New Value Set For HTAs Will Impact UK Drug Pricing (Pink Sheet)
Pharma & Biotech
Mirum to buy Bluejay for up to $820 million in bet on liver-disease drug (Reuters) (Endpoints)
Kymera drug positioned to rival Sanofi and Regeneron’s Dupixent succeeds in early-stage eczema trial (STAT)
Merck outbid three competitors in $9.2B acquisition of Cidara (Endpoints)
Updated: Structure Therapeutics’ obesity pill stacks up with Novo and Lilly; Ascletis also reports early results (Endpoints)
BioNTech, OncoC4’s antibody more than halves risk of death in Phase 3 lung cancer trial (Endpoints)
Kura, Syndax detail data for rival menin inhibitors as both eye earlier use in AML (Endpoints)
Dyne says Duchenne drug succeeds in pivotal study, heads to FDA for approval (Endpoints)
Cogent’s mastocytosis drug continues momentum, helps treat sicker patients (Endpoints)
Recursion Pharma's AI-powered therapy reduces polyp growth in a rare disease trial (Reuters)
Medtech
My continuous glucose monitor graphs my life — but misses the big picture (STAT)
Freenome inks deals to list stock and raise $330M (MedTech Dive)
FDA advisory panel votes unanimously against J&J heart shunt (MedTech Dive)
Olympus-backed Swan EndoSurgical names Erik Todd as CEO (MedTech Dive)
Medtronic’s Hugo RAS Gets FDA Nod For Urologic Procedures, But Intuitive Still Leads, Analyst Says (MedTech Insight)
Olympus Hits Another Endoscope Snag, Updates Instructions For PolyLoop After 113 Serious Injuries (MedTech Insight)
CorWave Ready To Dive Into LVAD Market Following First-In-Human Study (MedTech Insight)
Food & Nutrition
White House to roll out $12 billion farm package (The Hill)
Government, Regulatory & Legal
Tylenol Maker Lacks Texas Business Registration, Judge Says (Bloomberg)
You Better Move Fast: ACCESS to TEMPO (FDA Law Blog)
HBV Is Only The Beginning: US CDC’s ACIP Targeting Vaccine Adjuvants Next (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.