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November 20, 2023
by Jason Scott

Recon: Medtronic wins FDA nod for hypertension device despite expert panel misgivings; FDA lists recall of B. Braun Medical pump system as Class I

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Merck cough drug doesn’t pass panel scrutiny (STAT)
  • FDA approves Medtronic high blood pressure device despite a negative advisory panel vote (STAT)
  • What Eli Lilly’s Zepbound reveals about the intricate process of naming drugs today (STAT)
  • The FDA is at a crossroads on cell and gene therapies (STAT)
  • FDA identifies recall of B. Braun Medical pump system as most serious (Reuters)
  • Eli Lilly extends tender offer to buy Point Biopharma after low participation (Reuters)
  • US FDA to delay decision on Bristol Myers-2seventy bio cancer therapy (Reuters)
 
In Focus: International
  • U.K., pharma industry strike deal for how the NHS pays for medicines (STAT) (Reuters)
  • Exclusive: Manufacturer Lonza says it will not fill obesity drug syringes (Reuters)
  • 'Faster together': AstraZeneca breaks into clinical services business with new company launch, lining up two CRO partners to start (Endpoints)
  • Q&A with Judith Ng-Cashin, CRO Novotech's chief medical officer, on 2023 and beyond (Endpoints)
  •  
Pharma & Biotech
  • Legend Biotech’s deal with Novartis is a reminder that biotech’s bear market has a few haves, and many have-nots (STAT)
  • CRISPR’s pioneers reflect on the first gene-editing treatment (STAT)
  • Bayer recalls one lot of cancer drug Vitrakvi due to contamination (Reuters)
  • Bayer woes pile up as blood thinner drug trial fails (Reuters)
  • Researchers return to Alzheimer's vaccines, buoyed by recent drug success (Reuters)
  • Wegovy craze was all the rage on Q3 earnings calls (Reuters)
  • CAR-T cell therapies infused into brain shrink tumors in two glioblastoma studies (Endpoints)
  • Obesity and diabetes biotech Carmot Therapeutics files for IPO (Endpoints)
  • Q32 Bio to take Homology Medicines’ Nasdaq spot to fund PhII trials in autoimmune, inflammatory conditions (Endpoints)
Medtech
  • Hospitals put tech spending on a tight leash, raise the bar for pilots (STAT)
  • Amgen lines up new AI biotech partner in PostEra to develop small molecule medicines (Endpoints)
  • Q3 recap: Medtech firms grapple with layoffs, GLP-1s and China slowdown (MedTech Dive)
  • FDA acts on industry call for clarity about scope of device shortage reporting rules (MedTech Dive)
 
Government, Regulatory & Legal
  • How a major hospital shows just how inflated hospital list prices are (STAT)
  • Merck loses bid to hold Bayer responsible for talc foot powder claims (Reuters)
  • Mother of autistic children lodges complaint over emissions from Sanofi's Depakine drug plant -Le Monde (Reuters)
  • Biden taps Vanderbilt’s Kimryn Rathmell to succeed Bertagnolli as the NIH's cancer chief (Endpoints)
  • US to offer more free COVID tests nationwide (Reuters)
 
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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