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)
- 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)
- 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)
- 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)
- 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)
- 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)
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