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September 3, 2024
by Jason Scott

Recon: Top EU court favors Illumina over EU regulators in Grail deal; US will still pay more for drugs than its peers after Medicare price negotiations

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

In Focus: US
  • Letting funding for the All of Us research program lapse will cost the U.S. far more than it saves (STAT)
  • FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain (Reuters)
  • Emergent Bio's smallpox vaccine gets US approval for mpox (Reuters)
  • At major cardiology conference, Wegovy’s the word (STAT)
  • The alliance between RFK Jr. and Trump all comes down to their health-related worldview (STAT)
  • Updated: Vaxcyte surges on Phase 1/2 data for 31-valent pneumococcal vaccine (Endpoints)
  • Exclusive: Duke spinout launches in hopes of prevailing with brain cancer bispecific where Amgen, Roche did not (Endpoints)
  • Rules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What’s a Company to do? (FDA Law Blog)
  • US will still pay at least twice as much after negotiating drug prices (Reuters)
  • Semnur Pharmaceuticals to go public via SPAC merger with Denali Capital in $2.5 bln deal (Reuters)
In Focus: International                                                                                                       
  • UK government partners with pharma on new £400M life science infusion (Endpoints)
  • European court sides with Illumina, saying regulators overstepped in scrutiny of Grail deal (STAT) (Reuters)
  • Novo Nordisk continues to grapple with patchy GLP-1 drug supply in Europe (Endpoints)
  • EU-US-Japanese-Indian Pharmacopeia Group Says ‘New Members Wanted’ (Pink Sheet)
  • Pharma Firms To Benefit From New UK Hub-And-Spoke Clinical Trial Network (Pink Sheet)
  • African drugmaker Aspen in talks to manufacture mpox vaccines (Reuters)
  • Mpox vaccines to arrive in DR Congo in next few days, WHO says (Reuters)
  • Japan Prepares For Mpox Vaccine Donation (Pink Sheet)
  • UK Regulator Explains Changes To Pharmacovigilance Rules From 2025 (Pink Sheet)
Pharma & Biotech
  • Sanofi says its new pill for multiple sclerosis succeeded in a key trial, boosting its research ambitions (STAT)
  • Recursion presents mixed data on lead AI-derived drug candidate for potentially fatal brain condition (STAT) (Reuters)
  • Alnylam shares slide after heart drug data fails to impress investors (Reuters)
  • Three Dyne executives leave as company reports new Duchenne drug data (Endpoints)
  • Praxis' epilepsy drug reduces seizures by 46% in pediatric patients in Phase 2 study (Endpoints)
  • Denali details accelerated approval plans; Jazz's $850M private offering (Endpoints)
  • ProKidney axes one Phase 3 study, aims for 'expedited approval pathway' using another (Endpoints)
  • Exclusive: PatientPartner raises $7M to help pharma companies match patients with mentors (Endpoints)
  • Arrowhead spotlights key pancreatitis figures from Phase 3 lipid disease study to differentiate itself from Ionis (Endpoints)
  • Springer Nature could launch IPO as soon as next week, sources say (Reuters)
Medtech
  • Explore the clinical tools that use race to steer care (STAT)
  • Embecta gets FDA nod for insulin patch pump (MedTech Dive)
  • ARPA-H program to focus on AI degradation in medical tools (MedTech Dive)
  • Medtronic’s chief medical officer of acute care and monitoring departs for new role (MedTech Dive)
  • Pathology group sues to block FDA lab test rule (MedTech Dive)
  • FDA finalizes Voluntary Malfunction Summary Reporting guidance (MedTech Dive)
  • FDA Announces Four New Device Classifications (MedTech Insight)
  • Renata Medical Headed To Market With Stent For Children With Congenital Heart Defects (MedTech Insight)
Government, Regulatory & Legal
  • Doctors use problematic race-based algorithms to guide care every day. Why are they so hard to change? (STAT)
  • Diagnosed with cancer, a pharmaceutical executive became a patient advocate and changed drug development. It took decades (STAT)
  • Drug distributors strike $300 mln opioid settlement with US health plans (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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