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2 December 2024
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.