Novo Nordisk: obesity drugs priority over century-old focus on insulin (Reuters)
Novo Nordisk tempers expectations for hefty M&A deals as diabetes, obesity sales soar (Endpoints)
CVS and Walgreens say pharmacist work action had minimal impact (Reuters)
Nostrum Labs and its CEO — who once defended Shkreli price hikes — to pay up to $50 million over Medicaid rebates (STAT)
New antibiotic targets gonorrhea as well as last existing treatment, study shows (STAT)
Sangamo sheds staff once again in another retreat (Pharmaphorum)
Gene editing has had a big week in the spotlight. Here’s what’s going on (STAT)
Gene therapy biotech Locanabio to shutter by year’s end (Endpoints)
Intellia suggests ATTR amyloidosis gene editing treatment has over a year of durability as it gears up for PhIII (Endpoints)
Medtech
EU Regulatory Roundup, October 2023: Notified Bodies Fire On All Cylinders To Manage Challenges (MedTech Insight)
Treating Rural America: The telehealth solution (STAT)
With a new center, All of Us tackles health data silos to power precision medicine (STAT)
CooperCompanies buys reproductive health products from Cook Medical after failed takeover (MedTech Dive)
Drilling down on obesity drugs: What medtech executives are saying (MedTech Dive)
FDA warning letter accuses Wavi of selling unapproved neurological device (MedTech Dive)
Can Digital Twin Technology Help Beat Chronic Disease? Twin Health Is Getting Users Hooked, And Off Their Meds (MedTech Insight)
SerenOx Africa Addresses Drug-Dx/Chicken-Egg Problem In African Health Care (MedTech Insight)
Leo Grady’s Jona Hopes To Repair Microbiome Testing’s Murky Reputation (MedTech Insight)
Government, Regulatory & Legal
Do celebrity vaccine endorsements like Travis Kelce’s actually change behavior? (STAT)
US hospital groups sue Biden administration to block ban on web trackers (Reuters)
A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny? (FDA Law Blog)
Stryker’s Lisa Kloes talks cementless implants, robotics as future of knee business (MedTech Dive)
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.
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices.