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November 2, 2023
by Jason Scott

Recon: CBER chief said FDA’s confidence in gene editing is growing; Belgium confiscates counterfeit weight-loss drugs

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

In Focus: US
  • After Sarepta trial failure, families and doctors brace for another debate on Duchenne therapy (STAT)
  • US FDA’s Confidence In Gene Editing Safety Growing Enough That Regulatory Bar May Be Lowered (Pink Sheet)
  • Moderna reins in 2023 COVID vaccine forecast, shares tumble (Reuters)
  • Updated: Eli Lilly's Mounjaro sales hit $1.4B for the quarter, but FDA decision on Alzheimer's drug is delayed (Endpoints)
  • Novo Nordisk: 80% of U.S. Wegovy patients with insurance paying less than $25/month (Reuters)
In Focus: International
  • EMA To Address Scientific Advances In Guidance For Flu Vaccine Innovators (Pink Sheet)
  • EU’s ‘Significant Benefit’ Metric For Orphan Drugs Still A Thorn In Industry’s Side (Pink Sheet)
  • Belgium seizes fake weight-loss drugs containing insulin (Reuters)
  • Shanghai Eyes Commercial Insurance Push To Address Drug Firms’ Pricing Concerns (Pink Sheet)
 
Pharma & Biotech
  • BioMarin's longtime CEO Jean-Jacques Bienaimé hands the reins to Genentech's Alexander Hardy (Fierce Pharma)
  • Novo Nordisk is concluding research on Wegovy’s impact on osteoarthritis (STAT)
  • UPDATE 6-Novo Nordisk flags big 2024 sales boost despite Wegovy curbs (Reuters)
  • 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.
 

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