Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight European countries

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• FDA flags four deaths in Newron's schizophrenia drug studies (Reuters)
• Pfizer’s Tukysa regimen wins another FDA approval (The Pharma Letter)
• Novartis' Rhapsido gains new FDA approval (The Pharma Letter)
• FDA says its safety review of abortion pill will continue into next year (AP News)
• FDA expands use of Novartis drug for chronic skin condition (Reuters)
• AbbVie’s Temab-A receives two FDA breakthrough statuses (The Pharma Letter)
• First and likely only entrant in FDA’s split real-time review pilot is Arrowhead’s Plozasiran (Pink Sheet)
• FDA growing: August another net positive hiring month (Pink Sheet)
• Biotech companies are struggling to navigate Trump’s new tariffs (STAT)

In Focus: International

• Dutch court blocks subcutaneous Keytruda in eight European countries (Endpoints) (STAT)
• MHRA approves catumaxomab for malignant ascites (The Pharma Letter)
• Missing EU trial results prompt new compliance push and potential quality checks (Pink Sheet)
• EMA seeks more industry data to scale global reliance on its assessment reports (Pink Sheet)
• Russia says checks following Siberian plague lab death are complete (Reuters)
• WHO advises against obesity drugs for younger children (Endpoints)
• Roche does fourth China deal since August, teaming with Defand on degraders (Endpoints) (STAT)
• TCGX doubles down on China with $600M Asia-focused fund (Endpoints) (The Pharma Letter)
• Lupin launches triple-combination COPD inhaler in India, billing it a world first (The Pharma Letter)
• China has nominated health official Song Li as WHO head (Reuters)

Pharma & Biotech

• US government, Google join Zuckerberg-backed Biohub in $1.8 billion push for AI biology data (Reuters) (Endpoints)
• Viatris bets on non-opioid pain drugs with $1.65 billion Pacira deal (Reuters)
• CAR-T biotech Caribou to pull the plug after struggling to find funding (Endpoints) (BioPharma Dive)
• Theramex pays up to $250 million for Asieris' novel cervical lesion treatment (Fierce Pharma)
• Ultragenyx to sell rare PRV for $210 million (The Pharma Letter) (Endpoints)
• Matchpoint Therapeutics closes $150 million financing to advance pipeline (The Pharma Letter) (Endpoints)
• Argenx's study flop in Sjögren's overshadows a win in celiac disease (Endpoints) (Fierce Biotech)
• Glaukos says late-stage eye disease treatment shows lasting benefits after single dose (Reuters)
• Vaccine for deadly brain cancer narrowly misses goal in key trial (Endpoints)
• Cerevance Parkinson’s drug shortens ‘off time’ in phase 3, paving path to FDA (BioSpace)

Medtech

• Apple ordered to pay Masimo $184 million in interest on patent damages (MedTech Dive)
• Stryker CEO Kevin Lobo plans to hand over helm to current COO Spencer Stiles (Medtech Insight)
• Medtronic names Felicia Kurz as cardiac ablation VP, GM (MedTech Dive)
• First devices selected for EU joint assessment process that has faced pharma skepticism (Medtech Insight)
• ‘Worse performance than previously disclosed’ prompts Class I recall of BD Alaris infusion pump sets (Medtech Insight)
• ARPA-H is building agentic AI for heart failure and a blueprint for everyone who follows (Medtech Insight)
• Medical device maker Centinel Spine discloses revenue rise in US IPO filing (Reuters)
• Japan OKs Elixir’s DynamX Bioadaptor for coronary artery disease; mid-2027 market launch planned (Medtech Insight)
• European medtech growth slows to 1.8%, as industry pushes for market that can match US (Medtech Insight)
• Zenflow raises $52M, inks distribution deal with Cook Medical (MedTech Dive)

Food & Nutrition

• American Academy of Pediatrics calls for nationwide ban of raw milk (Food Safety News)
• FDA begins onsite inspections in E. coli, Listeria outbreak investigations (Food Safety News)
• More people sick in outbreak traced to sprouting seeds (Food Safety News)
• Researchers raise concerns about multidrug-resistant Campylobacter circulating across sectors and countries in Europe (Food Safety Magazine)

Government & Legal

• PhRMA sues Trump administration over GLOBE drug pricing demo program (Endpoints) (STAT)
• US appeals court weighs whether ACIP appointments can be challenged (Pink Sheet) (Reuters)
• How CMS plans to fix a major flaw in the 340B drug discount program (STAT)
• Justice Department targets drugmakers in new directive on combating white-collar fraud (STAT)
• Trump administration proposes $70,000 fee for popular international student work program (STAT)
• Kennedy plans federal vaccine injury initiative, drawing wary eye from experts (New York Times) (Pink Sheet)
• HIV research networks face uncertain future amid funding delays (New York Times)
• US states label abortion drugs a 'public nuisance' in bid to curb access (Reuters)
• In DC, a secretive new thorn has appeared in the pharma industry's side (Endpoints)
• Dozens of Democrats vie for slots on key House health committees (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.