Recon: Novo Nordisk asks FDA to block semaglutide compounding; Roche inks potential $1B gene therapy deal with Dyno

• 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)