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June 27, 2024
by Jason Scott

Recon: Supreme Court tosses Purdue’s bankruptcy plan; FDA rejects Merck, Daiichi’s lung cancer drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Key health care topics to watch out for at the Biden-Trump debate (STAT)
  • Supreme Court rejects Purdue bankruptcy plan (STAT)
  • US FDA declines to approve Merck-Daiichi's 'guided missile' cancer drug (Reuters) (Endpoints)
  • SoftBank Group launches AI healthcare joint venture with Tempus AI (Reuters)
  • Future Pak withdraws offer to buy Vanda Pharmaceuticals (Reuters)
  • Rite Aid seeks bankruptcy court approval to cut $2 billion debt (Reuters)
  • Altria seeks FDA marketing order for oral nicotine pouch products (Reuters)
  • US FDA approves Verona Pharma's inhaled COPD therapy (Reuters)
  • GSK shares slide after US health agency narrows scope of RSV shots (Reuters)
In Focus: International
  • U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
  • Indian regulator says 36% of inspected drug-making units had to be shut (Reuters)
  • EMA Updates Pre-Authorization Procedural Advice To Cover Joint Clinical Assessments (Pink Sheet)
  • EU Ministers Call For Tougher Shortage Notification Rules & Fines In Pharma Reform (Pink Sheet)
  • Pakistan’s Regulator Offers Pharmacovigilance Training Amid Compliance Challenges (Pink Sheet)
  • Divisional Patents Remain Divisive In Europe (Pink Sheet)
  • Joint Clinical Assessments: How The EMA Will Work With EU Member States On Information Exchange (Pink Sheet)
  • China approves AstraZeneca's Tagrisso-chemo combo as first-line treatment (Reuters)
  • South Korea's SK Bioscience to buy control of Germany's IDT Biologika for $244 mln (Reuters)
  • German vaccine panel endorses Astra-Sanofi's RSV shot for infants (Reuters)
  • Congo authorities approve mpox vaccines to try to contain outbreak (Reuters)
Pharma & Biotech
  • Exclusive: European VC Forbion hires Dyne CEO, expands in US (STAT)
  • Biogen is pursuing more dealmaking this year, with plans to spend up to $8B (Endpoints)
  • Q&A: Vertex’s pain research chief on moving beyond opioids, AI and how pharma acquisitions thrive or fail (Endpoints)
  • Recursion’s $200M offering; Sanofi invests $40M in Vigil Neuroscience (Endpoints)
  • AbbVie buys Third Rock's Celsius for $250M to expand IBD pipeline (Endpoints)
  • Silence reports Phase 1 data from rare blood disorder trial (Endpoints)
  • One Medical CEO-turned-VC wants startups that are 'disruptive from within the ecosystem' (Endpoints)
  • Exclusive: To develop better cell therapies for solid tumors, a new startup plans to test hundreds of them at once (Endpoints)
  • Sanofi-backed Formation Bio raises $372 million in late-stage funding round (Reuters)
Medtech
  • Q&A: Defining responsible AI in health care, with CHAI CEO Brian Anderson (STAT)
  • Are expensive whole-body MRI scans medically useful? A new clinical trial aims to find out (STAT)
  • Baxter recalls ventilation systems for charging malfunctions (MedTech Dive)
  • Medtronic CFO Karen Parkhill jumps ship to HP (Reuters)
  • FDA partners with Gates Foundation to support breath-based diagnostic development (MedTech Dive)
Government, Regulatory & Legal
  • Hospital at home program is waiting on Congress, but this New Jersey hospital isn’t (STAT)
  • Supreme Court kicks Idaho emergency abortion ban back to lower court (STAT)
  • Q&A: Lessons from the HHS secretary who ran Bush’s bird flu response (STAT)
  • AI and rural health care: A paradigm shift in America’s heartland (STAT)
  • Walgreens cuts profit view, looks to shut more stores on spending hit (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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