Recon: Novo Nordisk asks FDA to block semaglutide compounding; Roche inks potential $1B gene therapy deal with Dyno
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Gilead needs a win with Arcellx CAR-T data. Here’s how to know if it scores (STAT)
- Elon Musk bungles his criticism of US drug regulators (STAT)
- The key ballot measures and races to watch that could reshape health care (STAT)
- Ozempic linked to lower risk of Alzheimer’s diagnosis in observational study (STAT)
- How a Kamala Harris presidency would change health care, from drug pricing to abortion (STAT)
- CRISPR therapy reduces swelling attacks by 81% in Intellia follow-up study (Endpoints)
- Novo Nordisk petitions FDA to stop semaglutide compounding over safety risks (Endpoints)
- Weight-loss drugs didn't curb health costs within two years (Reuters)
- GOP Wants Check-In On FDA’s Lab Safety Issues (MedTech Insight)
- Baxter expects to restart IV solutions manufacturing line within next week (Reuters)
- Exclusive: Moldova clears first gene editing study for HBV in humans (Endpoints)
- EU HTA Regulation: Assessors Risk Exclusion for Secrecy Breaches (MedTech Insight)
- Swiss Medtechs Eye Near-Term Regulatory Progress On EU And FDA Fronts (MedTech Insight)
- Lilly to launch its obesity drug in Denmark, Novo Nordisk's home market (Reuters)
- UK to ban disposable vapes from June to crack down on teen use (Reuters)
- Indian drugmaker Glenmark Life Sciences' Q2 profit drops on temporary closure of facility (Reuters)
- Vaccine bond raises $1 bln for immunisations after record demand (Reuters)
- Roche Inks Potential $1B Gene Therapy Deal With Dyno, Eyes Neurological Diseases (BioSpace)
- General Catalyst raises $8 billion fund with $750 million for health care bets (STAT)
- Moderna mounts campaign to boost vaccine eligibility awareness (Fierce Pharma)
- GSK answers Pfizer's RSV approval with data targeting matching nod in younger adults (Fierce Pharma)
- Exclusive: University of Toronto spinout raises $53.5M to create new obesity drugs with AI (Endpoints)
- Lonza extends contract with unnamed pharma; Rentschler's new build (Endpoints)
- Marinus plans another round of layoffs, cost cuts following Phase 3 fail (Endpoints)
- Zai Lab unveils early lung cancer data as it looks to challenge Amgen's Imdelltra (Endpoints)
- Bayer, Dewpoint to work on heart drug; Viking’s obesity manufacturing plans (Endpoints)
- Dexcom beats estimates for third-quarter sales, reiterates annual forecast (Reuters)
- Labcorp's quarterly results beat on diagnostic tests demand (Reuters)
- European Parliament calls for proposals to reform MDR and IVDR by end of Q1 (MedTech Dive)
- iRhythm’s Zio AT design changes win FDA clearance (MedTech Dive)
- Boston Scientific boosts PFA expectations, citing rapid Farapulse adoption (MedTech Dive)
- Oxford Medical Products Unveils Positive Phase 2a Trial Data For Mechanical Weight-Loss Pill (MedTech Insight)
- US CDC recommends expanding pneumococcal vaccines to adults aged 50-64 (Reuters)
- Facing lost rebates, MGM Resorts to stop covering GLP-1 weight loss shots (Endpoints)
- Health startups need consolidation after pandemic funding ‘sugar high’ (MedTech Dive)
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