Recon: Supreme Court to consider skinny labeling case; Opioid settlement likely after Purdue Pharma sentencing

In Focus: US

Supreme Court to hear case about ‘skinny labeling’ and generic access (STAT)
New U.S. recommendation on hepatitis B vaccine will have dire consequences, studies project (STAT)
Updated: FDA claims trial 'manipulation' tainted approval of ChemoCentryx drug now owned by Amgen (Endpoints)
Purdue Pharma to be sentenced, paving way for opioid settlement (Reuters)
US FDA Unveils Real-Time Clinical Trials To Speed Data Review (Pink Sheet)

In Focus: International

Novartis CEO disheartened by Germany’s planned €60B cuts to healthcare spending (Endpoints)
Exclusive: Ghana rejects proposed US health aid deal, citing data concerns (Reuters)
UK Must Tackle ‘Variation’ In Clinical Trial Set Up Times, Says O’Shaughnessy (Pink Sheet)
Regeneron Seeks EU Fast-Track Review For Hearing Loss Gene Therapy Following Swift US Approval (Pink Sheet)

Pharma & Biotech

Eli Lilly enlists AI startup for next-generation gene editors (STAT)
Erasca touts strong, though preliminary, results in trial of pancreatic and lung cancer therapy (STAT)
Updated: AbbVie flirts with popular pan-RAS field in up to $1.45B option to acquire Kestrel (Endpoints)
BeOne joins the VEGF competition, but with a trispecific antibody (Endpoints)
Incyte claims double Phase 3 win in vitiligo, will file for approval (Endpoints)
AI keeps tackling harder targets in protein design, latest Adaptyv contest shows (Endpoints)
Lilly strikes second partnership this year for recombinase-based gene editing (Endpoints)
Galapagos spinout Coultreon raises $125M for new take on SIK inhibition (Endpoints)
Boehringer-Zealand drug leads to 16.6% weight loss in late-stage trial (Reuters)
Centene raises 2026 profit forecast on improving cost controls (Reuters)
With ‘lessons learned,’ Kite prepares to hit the ground running as next-gen CAR-T decision looms (Fierce Pharma)

Medtech

Zimmer Biomet CFO departs for new job (MedTech Dive)
Thermo Fisher inks $1.1B deal to sell microbiology unit to Astorg (MedTech Dive)
Medtronic reports data breach on corporate IT systems (MedTech Dive)
Medtronic Catheter Shows Promise in Treating Dangerous Heart Disorder (MedTech Insight)

Food & Nutrition

Argentina has 'serious' concerns after soymeal shipments withdrawn in EU over GMO breaches (Reuters)
Salmonella outbreak spreads across Europe (Food Safety News)
Bill would give FDA permission to provide states with food safety information (Food Safety News)

Government, Regulatory & Legal

Devoted Health’s 2025 revenue slips in turbulent Medicare Advantage market (Endpoints)
Not So Fast: When “RAPID” Isn’t Enough (FDA Law Blog)

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.