Recon: Sanofi planning €1B manufacturing investment in Beijing; Ex-FDA chief Gottlieb raises concerns about RFK Jr. nomination
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Former Trump FDA chief is seeking to undermine RFK Jr.’s Senate confirmation (STAT)
- A Hostile Takeover Of US FDA? (Pink Sheet)
- US Supreme Court wrestles with FDA denial of flavored vape products (Reuters)
- Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable (FDA Law Blog)
- The Good, The Bad, And The Uncertain: Trump’s Second Administration And The Rx Industry (Pink Sheet)
- FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports (Fierce Pharma)
- Novocure's pancreatic cancer treatment meets main goal in late-stage study (Reuters)
- Despite probe, China reimbursing AstraZeneca drug (STAT)
- A new moonshot initiative to fight cervical cancer in the Indo-Pacific region is missing something (STAT)
- Sanofi announces its biggest China investment deal amid China-EU trade tensions (Reuters)
- Argentina HIV patients, medics fear impact of Milei's spending cuts (Reuters)
- Wider Gene Therapy Definition In EU Will Require ‘Myth-Busting’ From EMA (Pink Sheet)
- EU Biosimilar Filings, Opinions And Approvals (Pink Sheet)
- GSK takes AMR message to Paddington, bearing responsibility for raising awareness of risks (Fierce Pharma)
- Novartis to pay $1 billion upfront to license Huntington’s drug from PTC (STAT)
- Olema, Novartis ink another agreement, this time for a late-stage breast cancer trial (Endpoints)
- ‘Significant talent shortage’ threatens the rise of radiopharmaceuticals (STAT)
- Race is on for oral obesity drugs with multiple phase 3 trials vying for next-gen status in a $126B market (Fierce Pharma)
- Senti Bio’s Phase 1 CAR-NK data; Allink raises $42M (Endpoints)
- Agenus launches biologics manufacturing business to generate cash (Endpoints)
- Merus drug shows ‘unexpected improvement’ in second-line head and neck cancer study (Endpoints)
- Apogee targets Dupixent head-to-head next year as it outlines broad pipeline plans (Endpoints)
- Gene Therapy: Lyfgenia Voucher Denial Puts Sickle Cell Treatment At Risk, Bluebird Bio Says (Pink Sheet)
- Regulatory tracker: J&J seeks pediatric FDA approvals for Tremfya (Fierce Pharma)
- Novocure says electric field therapy extends life for pancreatic cancer patients by two months (Endpoints)
- J&J appoints Shawn Millerick to lead vision care unit in the Americas (MedTech Dive)
- Guardant awarded nearly $293M in false ad trial against Natera (MedTech Dive)
- Exact Sciences: Lower Guidance, But Payer Care Gap Programs Plan Shows Promise (MedTech Insight)
- Guardant Health Eyes Earlier Breakeven As Liquid Biopsy Boosts Outlook (MedTech Insight)
- Big restaurant chains get an ‘F’ for antibiotic use in their meat supplies (STAT)
- What YouTube Health is doing to combat misinformation and promote evidence-based content (STAT)
- Congress’ critical opportunity to reshape health care (STAT)
- Medtech Industry Backs Two-Speed EU MDR Revision And Rapid Changes (MedTech Insight)
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