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October 6, 2025
by Jason Scott

Recon: CDC approves new COVID vaccine recommendations; AstraZeneca licenses Algen AI gene-editing platform for $555M

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

In Focus: US
  • CDC approves updated Covid-19, chickenpox vaccine recommendations (STAT) (Reuters)
  • Acting CDC director O'Neill calls on vaccine makers to separate combined MMR shot (Reuters)
  • Trump administration delays effort to address Medicare drug price negotiation loophole (STAT)
  • FDA to rework 'CERSI' university collaborations, will make funding changes (Endpoints)
  • FDA launches pilot program to improve US generic drug manufacturing (Endpoints)
  • Measles-free status in jeopardy in the Americas as outbreaks continue (Reuters)
  • Kennedy push for autism drug gets a boost from pharma (Reuters)
  • Johnson: ACA subsidy deadline an ‘eternity’ away (The Hill)
  • Carve Away: D.C. Circuit Keeping the “Chubby Label” Carve-Out Alive (FDA Law Blog)
  • US Supreme Court will not hear Purdue appeal in OxyContin patent case (Reuters)
In Focus: International
  • AstraZeneca signs up to $555 million AI deal with Algen to develop therapies (Reuters)
  • With much to win (or lose), drugmakers and European officials bear down on major policy overhaul (STAT)
  • Keeping it simple: Chen Yu steers into round three with $1.3B biotech fund (Endpoints)
  • Cell therapy CDMO Mytos unveils its first facility in the UK (Endpoints)
  • WHO estimates at least 15 million teenagers use e-cigarettes worldwide (Reuters)
  • ‘We Are Not The Dark Side Of The Force’ – EU Regulator Urges ATMP Firms To Use Advice Services (Pink Sheet)
  • Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations (Pink Sheet)
Pharma & Biotech
  • Amgen says its cholesterol shot prevented heart problems in a broad population (STAT)
  • Skye’s obesity drug fails in mid-stage study (STAT)
  • 2025 Nobel Prize in medicine goes to Mary Brunkow, Fred Ramsdell, and Shimon Sakaguchi for immune system discoveries (STAT) (Endpoints)
  • Abivax releases more data from major Phase 3 wins in ulcerative colitis (Endpoints)
  • Metsera got less than it wanted from Pfizer in long-awaited obesity biotech acquisition (Endpoints)
Medtech
  • From erectile dysfunction to weight loss, how telehealth got hooked on drug-first thinking (STAT)
  • Coverage for telemedicine has ended abruptly. For my patients and me, it’s a disaster (STAT)
  • Mid-stage health tech startups struggling to raise, report finds (Endpoints)
  • Revvity, Sanofi team on early Type 1 detection; Kihealth raises funds for diabetes test rollout (MedTech Dive)
  • Biolinq Aims To ‘Shine’ In Early 2026 With Needle-Free CGM US Debut, Human Data On Protein Sensor (MedTech Insight)
Food & Nutrition
  • More than 250 sick in German E. coli outbreak (Food Safety News)
  • FDA increases import requirements on shrimp, spices from Indonesia because of radioactivity (Food Safety News)
Government, Regulatory & Legal  
  • Onshoring could threaten the resilient supply chain for biosimilars and generics (STAT)
  • Morgan ‘Dr. Noc’ McSweeney’s advice on becoming a science-based social media influencer (STAT)
  • Colorado board makes first-in-the-nation move by setting a payment limit on an Amgen drug (STAT)
  • How this week’s Supreme Court case on conversion therapy could impact the regulation of medicine (STAT)
  • The NIH ordered me to stop my ‘dangerous’ gain-of-function research. It isn’t dangerous at all (STAT)
  • She’s leading NIH’s push to reduce the use of animals in biomedical research (STAT)
  • As NIH launches new autism research effort, the focus is on environmental factors (STAT)
  • These Trump voters are wary of COVID shots, but don't want RFK to restrict other vaccines (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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