Recon: Marks says Kennedy’s team sought ‘nonexistent’ data on vaccines; Novo to invest $1.09B to increase Ozempic, Wegovy production in Brazil
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Trump layoffs begin to erode FDA drug review system (Reuters)
Ousted Vaccine Chief Says RFK Jr.’s Team Sought Data to Justify Anti-Science Stance (WSJ)
‘Most effective way’ to prevent measles is vaccination, RFK Jr. says, in most direct remarks yet (STAT)
School-age child dies in Texas measles outbreak; health chief Kennedy visits family (Reuters)
U.S. may be reverting to a time when measles deaths were not very rare, experts warn (STAT)
BridgeBio CEO: Congress must renew a popular, bipartisan FDA program benefiting sick kids (STAT)
Trump administration drops Biden's proposal of Medicare weight-loss drug coverage (Reuters)
FTC eyes resuming insulin lawsuit against drug middlemen (Reuters)
In Focus: International
Novo Nordisk to invest $1.09 billion to boost Ozempic, Wegovy production in Brazil (Reuters)
Small-town Ireland nervous as Trump seeks to lure pharma investment to US (Reuters)
Britain to invest up to $767 mln in new health data research (Reuters)
Mexico reports first human case of H5N1 bird flu (Reuters)
UK's Assura gets deadline extension for potential PHP deal (Reuters)
Aid cuts could leave more women dying in pregnancy and birth, UN says (Reuters)
Pharma & Biotech
A brash biotech VC speaks out on headwinds in the industry, and what the future may hold (STAT)
Rhythm touts Phase 3 win for rare obesity drug in people with brain damage (Endpoints)
Cell and gene therapy CDMO AmplifyBio shuts down over 'scarcity' of funding (Endpoints)
Sarepta halts three studies testing gene therapy for muscle disorder (Reuters)
Q&A: A conversation with GLP-1 co-discoverer Jens Juul Holst on the future of incretin-based drugs (Endpoints)
Q&A: David Liu talks about science under pressure, teases “disease-agnostic” gene editing (Endpoints)
ADC startup DualityBio seeks Hong Kong IPO amid precarious market (Endpoints)
GSK’s newest neuro pact is with ABL Bio, a Sanofi-partnered South Korean biotech (Endpoints)
Medtech
New thought-to-speech brain device allows for ‘natural conversation’ (STAT)
A ‘wobbly’ moment in business: Manufacturers face life under Trump’s tariffs (MedTech Dive)
Labcorp launches blood test to accelerate Alzheimer’s diagnosis (MedTech Dive)
Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition (MedTech Insight)
Food & Nutrition
Texas opens probe into WK Kellogg over health claims (Reuters)
Quality, SQF, and the Importance of Changing Food Safety Behaviors (Food Safety)
Government, Regulatory & Legal
FDA’s Vape Ban Hits the Right Note: Supreme Court Says “Let It Be” (FDA Law Blog)
Don’t overlook the continued threat of cuts to universities’ indirect research costs (STAT)
HIV prevention was making great strides. Then Trump’s budget axe fell (STAT)
DOJ urges judge to move forward with Medicare Advantage fraud case against UnitedHealth (STAT)
Medicare gets a big (unofficial) surprise: a 17-year extension on when it’ll run dry (STAT)
CDC’s top laboratory on sexually transmitted diseases is shut by Trump administration (STAT)
Bayer renews bid for US Supreme Court to curb glyphosate cases (Reuters)
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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.