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October 10, 2024
by Jason Scott

Recon: Baxter increases allocations of IV fluid amid shortages; GSK to settle 80,000 Zantac lawsuits for as much as $2.2B

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

In Focus: US
  • Frustrated telehealth providers say their businesses face ‘doom and gloom’ (STAT)
  • Sarepta’s gene therapy is fully approved, but its stock has tanked. Here’s why (STAT)
  • Warren urges FTC to probe deal that would give Novo Nordisk control of some Catalent plants (STAT)
  • Baxter ups IV fluid allocations amid supply shortages (MedTech Dive)
  • 10 people to watch who could shape health policy in a Harris administration (STAT)
  • Exclusive: How an accidental email tipped Pfizer off to an activist investor’s plan (Endpoints)
  • Starboard launches first salvo in Pfizer fight, alleging ex-CEO, CFO were pressured to flip (Endpoints)
  • Pfizer's cancer drug combo improves overall survival in late-stage study (Reuters)
  • GSK agrees to settle about 80,000 Zantac lawsuits for up to $2.2 bln (Reuters)
  • IRA Impact On Biopharma R&D Bears Watching, US FDA’s Cavazzoni Says (Pink Sheet)
In Focus: International                                                                                                       
  • Swiss competition authority closes Novartis probe without consequences (Reuters)
  • EU Drug Regulators Seek Help To Shape Network's Future Until 2028 (Pink Sheet)
  • EU Authority Mulls Paying For Late-Stage Research As A Pull Incentive For Neglected Disease Drugs (Pink Sheet)
  • Coping Strategies For China Industry Amid BIOSECURE Overhang (Pink Sheet)
  • Janssen’s Nipocalimab Among Six New EU Filings (Pink Sheet)
  • EU’s Medtech Rules Are A 'Bureaucratic Monster,' European Parliamentarians Say (MedTech Insight)
  • Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50 (MedTech Insight)
Pharma & Biotech
  • 7 children developed blood cancer after Bluebird Bio gene therapy for rare neurological disease (STAT)
  • Ono’s ADC deal; Leo Pharma to conduct layoffs (Endpoints)
  • Suki nabs $70M Series D to arm doctors with AI tools (Endpoints)
  • Indivior's opioid treatment sales slump prompts second profit warning (Reuters)
Medtech
  • Eli Lilly has an AI chief, telehealth’s DEA troubles, and FDA’s thinking on AI in clinical trials (STAT)
  • AI biotechs Recursion and Exscientia first held deal talks in 2022 (Endpoints)
  • Lead testing device company Magellan sentenced for concealing defects (Reuters)
  • Illumina launches compact, low-cost gene sequencing devices (Reuters)
  • Next 510(k) Third Party Review? Medtechs May Take Wait-And See Approach To PCCPs (MedTech Insight)
  • CMR Surgical CEO Bose steps down (MedTech Dive)
  • Shiratronics raises $66M for trial of neuromodulation migraine device (MedTech Dive)
  • The number of AI medical devices has spiked in the past decade (MedTech Dive)
  • Procept secures FDA approval to study surgical robot in prostate cancer (MedTech Dive)
Government, Regulatory & Legal
  • Medical journal peer reviewers are paid millions by industry, study finds (STAT)
  • Epic Systems v. Particle: What the Carequality investigation reveals about the dispute (STAT)
  • Amid a rough biotech job market, fewer biomedical Ph.D. grads head for industry, data show (STAT)
  • Is the future of AI in health care just a lot of hype? (STAT)
  • Getting R&D Right: NASEM Panel Weighs Strategies To Match Innovation With Disease Burden (Pink Sheet)
  • AHA asks Biden administration for relief amid IV fluid shortage from Hurricane Helene (MedTech Dive)
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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