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)
- 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)
- 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)
- 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)
- 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)
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