Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Gilead, Merck weekly HIV pill keeps virus suppressed in late-stage trials (Reuters) (Fierce Pharma)
- Novo Nordisk sues Eli Lilly over GLP-1 drug ads it calls ‘deceptive’ (STAT)
- House lawmakers rally behind trade probe of China biotech market (Endpoints)
- Alembic site slapped with FDA warning letter over patient consent concerns (Fierce Pharma)
- Lilly, BMS aerospace partner Redwire opens new site in Indiana (Fierce Pharma)
In Focus: International
- UK biotech VC funding rebounds and reaches record high (Endpoints)
- US-Based Axiom Seeks Hong Kong IPO to Tap China’s Biotech Boom (Bloomberg)
- French SMEs Blame Failure To Scale On EU MDR And Reimbursement Models (MedTech Insight)
- NewAmsterdam And LIB Await Crucial EMA Opinions On LDL-Lowering Therapies (Pink Sheet)
- EMA Decision Time For Orphan-Designated Linerixibat, Leriglitazone And Catequentinib (Pink Sheet)
Pharma & Biotech
- PolyPid, Azurity sign surgical site infection drug deal (Reuters)
- Agios scraps sickle cell treatment after trial shows limited benefit (Reuters)
- US launches pilot program to boost domestic production of veterinary drugs (Reuters)
- Broad Institute, partners unveil new initiative to develop gene therapies for rare diseases (STAT)
- Makers of rare disease drugs seek exemption from Trump’s price-cut pilots (STAT)
- Anti-Aging Claims And The US FDA: What Is The Right First Step? (Pink Sheet)
- Nabla’s new CEO on plan to gain market share in a competitive AI scribe environment (STAT)
- Exclusive: A David Baker spinout launches AI antibody data consortium with GSK, Boltz and others (Endpoints)
- Unpacking Anthropic's 100-day sprint into biopharma: Nobel hires, M&A and major ambition (Endpoints)
- UnitedHealth Group lays out progress in AI push (Endpoints)
- Samsung Bio to expand its wheelhouse in $1.8B buy for peptide API maker (Endpoints)
- Biotech IPO Gains Crush AI Listings With Standout 55% Return (Bloomberg)
- Activist Barington Pushes Chemed for Strategic Review (Bloomberg)
- Novartis CEO brushes off oral PCSK9 competition as Leqvio drives Q2 growth (Fierce Pharma)
Medtech
- GE HealthCare inks 10-year, $500M alliance with Catholic Health (MedTech Dive)
- FDA Tightens Stance On Terumo’s RelayPro: Return The Devices, Don’t Use Them (MedTech Insight)
- CorTec’s BCI Shows Early Promise In Stroke Rehab With 8 to 12 Point FMA-UE Gains (MedTech Insight)
Food & Nutrition
- THC drinks are sold beside sodas, iced tea, and even chocolate milk, often in violation of state laws (STAT)
- The Cyclosporiasis Outbreak Is a Master Class in Miscommunication (STAT)
Government, Regulatory & Legal
- Advocates say federal funding is being cut from groups fighting HIV (STAT)
- How a controversial rule could hurt the NIH’s ability to manage risk (STAT)
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.
