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November 12, 2024
by Jason Scott

Recon: Pfizer mulls over selling hospital drugs business; AstraZeneca plans $2B for US production, R&D boost

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

In Focus: US
  • Despite setback, AbbVie’s big bet on neuroscience has yet to play out (STAT)
  • 23andMe cuts 40% of its workforce, discontinues all therapy programs (Reuters) (STAT)
  • AstraZeneca budgets another $2B to boost manufacturing and R&D in US (Endpoints) (Reuters)
  • US FDA declines full approval for Intercept's liver disease drug (Reuters)
  • Novavax cuts 2024 revenue forecast again on lower COVID vaccine sales (Reuters)
  • Exclusive: Pfizer explores sale of hospital drugs unit, sources say (Reuters)
  • Kennedy’s F.D.A. Wish List: Raw Milk, Stem Cells, Heavy Metals (NYTimes)
In Focus: International
  • Merck KGaA plans China submission after late-stage win for tumor drug (Endpoints)
  • Bayer not eyeing new deals to address Xarelto sales erosion (Endpoints)
  • EU Regulatory Round-Up: How Medtech Lobbying Altered EU Parliament’s Stance (MedTech Insight)
  • Chinese Regulator Raises Red Flag On Clinical Trial Bribery (Pink Sheet)
  • EMA's Final Call On Alzheimer's Drug Leqembi Imminent (Pink Sheet)
  • New UK Rules On Supplementary Protection Certificates – Will You Be Affected? (Pink Sheet)
  • EU Crunch Time For Kizfizo, Sipavibart, Coacillium & Eight Other Products (Pink Sheet)
Pharma & Biotech
  • When even an ‘over the wall’ PIPE can’t help (STAT)
  • Fueled by a ‘fall off your chair’ discovery and $101 million, Trace launches to take on ALS (STAT)
  • Updated: AstraZeneca, Daiichi Sankyo replace lung cancer filing for Enhertu successor (Endpoints)
  • Apollo makes a deal worth up to $926M; Abeona resubmits gene therapy (Endpoints)
  • Neurogene's stock falls in post-market trading after early data in Rett syndrome (Endpoints)
  • Alentis nabs $181M to broaden Claudin's scope in ADCs (Endpoints)
  • Roche teams with Flare Therapeutics on transcription factors (Endpoints)
  • Exclusive: GV-backed Medicaid startup Diverge Health raises $52M (Endpoints)
  • Future Fields looks to solve industry's biomanufacturing woes with fruit fly-based protein production (Fierce Pharma)
  • Cardinal Health expands gastroenterology, diabetes businesses with two deals worth $3.9 bln (Reuters)
Medtech
  • Invest in ‘triple rapid’ tests to fight mpox, H5N1 bird flu, and beyond (STAT)
  • How Pfizer used wearables to tap into the promise of an experimental drug (STAT)
  • Octave Bioscience’s Multi-Biomarker Test Provides Key Insights To Predict Multiple Sclerosis Disease State (MedTech Insight)
  • J&J’s Ottava surgical robot to begin clinical trial after FDA nod (MedTech Dive)
  • Boston Scientific resumes PFA trial in new patient group after pausing enrollment (MedTech Dive)
  • GE Healthcare inks AI mammography pact with Radnet (MedTech Dive)
Government, Regulatory & Legal
  • The recovery community says it offers refuge from opioid addiction. But it’s still hostile to lifesaving addiction medications (STAT)
  • OpenAI isn’t built for health care. So why is its tech already in hospitals, pharma, and cancer care? (STAT)
  • US sues to block UnitedHealth's $3.3 bln purchase of Amedisys (Reuters)
  • US epidemic of sexually transmitted infections shows signs of slowing, CDC says (Reuters)
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.
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