Recon: Gilead to purchase Arcellx for nearly $8B; Top CDC deputy abruptly resigns
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Gilead to buy Arcellx in nearly $8B deal (STAT)
- Pharma lobbyists focus on a surprising new target: the FDA (STAT)
- Ralph Abraham, No. 2 official at CDC, abruptly steps down (STAT)
- FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications (STAT)
- Birth doses of hepatitis B vaccine on decline in US before CDC scrapped recommendation (Reuters)
- The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding (FDA Law Blog)
- Vanda, with FDA nod for Bysanti, gains 2nd new drug approval in as many months (Fierce Pharma)
- China-to-West pace escalates as Frontier, Harbour do licensing deals with GSK, Solstice (Endpoints)
- ‘Valuable Flexibility’: EMA’s Stepwise Pediatric Plans Most Impactful In Rare Diseases & Oncology (Pink Sheet)
- Does Korea Need A Policy Shift In Support For Late Clinical Trials? (Pink Sheet)
- ‘A deal is a deal’: EU halts US pact over Trump’s new global tariff (MedTech Dive)
- Novo Nordisk's CagriSema trial deals blow in obesity drug battle with Eli Lilly (Reuters)
- Gossamer lung disease drug fails late-stage study, but company will still seek FDA approval (STAT)
- Exclusive: First test of gene therapy for rare form of autism is underway (Endpoints)
- Flagship's Generate targets $2B+ valuation with Nasdaq IPO (Endpoints)
- Roche to stop work on bone health treatment for Duchenne (Endpoints)
- AbbVie budgets $380M for obesity and neuroscience API facilities in Chicago (Endpoints)
- Novo Nordisk's $475-billion rise and fall as Wegovy-era gains wiped out (Reuters)
- Girding against Keytruda cliff, Merck splits oncology into standalone business unit (Fierce Pharma)
- Bayer sues J&J over ‘deeply flawed’ promotional claims touting Erleada over Nubeqa (Fierce Pharma)
- CDMO Bora locks in 5-year, $250M production agreement with GSK (Fierce Pharma)
- Fortress sells FDA voucher for $205M after Zycubo approval last month (Fierce Pharma)
- Lilly adds multidose Zepbound pens to self-pay menu after FDA nod (Fierce Pharma)
- Catalent cuts staff by 96 in another round of layoffs in Maryland (Fierce Pharma)
- Novo Nordisk nominates 2 industry vets to board in latest leadership shake-up (Fierce Pharma)
- Lilly to launch multi-dose weight-loss drug device in US (Reuters)
- Guardant buys MetaSight for $59M upfront to acquire blood test tech (MedTech Dive)
- Grail’s multi-cancer early detection test misses study goal (MedTech Dive)
- Esperto Medical Bets On Physics, Not ML For Accurate, Cuffless Blood Pressure Monitoring (MedTech Insight)
- Baxter Hopes Recovery Under New CEO, Faces Near-Term Pressure (MedTech Insight)
- Dippin’ Dot parent says MAHA, GLP-1 trends aren’t melting demand for indulgent treats (Food Dive)
- Two charged for using fake USDA labels (Food Safety News)
- A federal experiment opens up a new market for digital health — if it works (Endpoints)
- Trump sets fresh 10% global tariff — and plans to increase further (MedTech Dive)
- Supreme Court Rebuke Of Trump Tariffs A Win For Medtech (MedTech Insight)
- US FDA’s Plausible Mechanism Guidance Looks Beyond Genome Editing, RNA-Based Therapies (Pink Sheet)
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