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November 21, 2024
by Jason Scott

Recon: Trump reportedly eying Martin Makary to lead FDA; Novartis acquires Kate Therapeutics for up to $1.1B

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

In Focus: US
  • Trump likely to pick Johns Hopkins surgeon, COVID mandate critic Makary for FDA, sources say (Reuters) (Bloomberg)
  • Top FDA official says Trump and RFK Jr. will mean ‘vigorous dialogue’ on vaccines (STAT)
  • FDA vaccine chief Peter Marks pledges to stay as long as he's welcome (Endpoints)
  • RFK Jr. is exploring a plan to upend Medicare’s physician payments system (STAT)
  • RFK Jr. wants to blow up the ‘corrupt’ FDA, but he could Make America Sick Again (STAT)
  • Wall Street awaits Amgen weight-loss drug data expected to move shares (Reuters)
  • Bluesky is the new destination for X/Twitter’s health and   science community. Here’s why (STAT)
  • FDA updates label of 33-year-old cancer drug with new dose and warning (Endpoints)
  • US FDA’s Drug Center Losing Shortages, Controlled Substance Leadership With Throckmorton Retirement (Pink Sheet)
  • Florida Gov. DeSantis’ Canadian Drug Import Plan Goes Nowhere After FDA Approval (KFF)
In Focus: International
  • After youth vaping surge, the U.K. moves to ban disposable e-cigarettes (STAT)
  • What records? Chinese company refuses to let FDA inspectors review documents or machinery (STAT)
  • HTA Bodies In England, US and Canada Collaborate On Developing Health Economic Methods (Pink Sheet)
  • EMA: Regulatory Decisions On Pediatric Cancer Drugs ‘Cannot Happen In Isolation’ (Pink Sheet)
  • Elon Musk's Neuralink receives Canadian approval for brain chip trial (Reuters)
  • Novartis buys gene therapy startup Kate Therapeutics, joining pursuit of muscular dystrophy treatment (STAT)
  • Novartis raises sales guidance until 2028 (Reuters)
  • Novartis: launch of Morphosys drug by could be 2027 or later (Reuters)
Pharma & Biotech
  • Versant enters obesity with new startup (STAT)
  • Cidara's $100M PIPE; Pyxis Oncology's stock falls on Phase 1 data (Endpoints)
  • Amgen names Stanford geneticist and biotech founder to CSO post (Endpoints)
  • Kyowa Kirin acquires ex-US rights to Kura’s leukemia treatment for $330M upfront (Endpoints)
  • NewAmsterdam aces Phase 3 trial, but investors are skeptical (Endpoints)
  • Venrock adds $500M to healthcare investing strategy after outlining 10th fund in January (Endpoints)
  • Pfizer taps oncology head Boshoff as Dolsten's chief scientific officer successor (Endpoints)
Medtech
  • A new device for delivering drugs without needles draws inspiration from the elegant squid (STAT)
  • Caltech spinout debuts with AI-driven 'mirror peptide' platform (Endpoints)
  • When generative AI meets the FDA: First digital health adcomm kicks off discussion (Endpoints)
  • Henry Schein to acquire medical supplier Acentus (MedTech Dive)
  • Verily alum looks to improve access to retinal scans (MedTech Dive)
  • Dexcom invests $75M in Ōura, agrees to integrate smart rings and CGMs (MedTech Dive)
  • Labcorp hires Julia Wang as CFO (MedTech Dive)
Government, Regulatory & Legal
  • Advamed CEO welcomes Dr. Oz as Trump’s pick to lead CMS (MedTech Dive)
  • The health care industry is girding for Trump’s tariffs —and pushing hard for carveouts (STAT)
  • Top Medicaid official says Republicans’ proposed reforms are ‘just plain bad policy’ (STAT)
  • US FDA Biosimilar Standards Likely Sealed Interchangeability Designation’s Fate (Pink Sheet)
  • Skinny Label Limits: Supreme Court Denies Norwich Bid For US Xifaxan Reprieve (Pink Sheet)
  • New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility (FDA Law Blog)
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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