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)
- 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)
- 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)
- 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)
- 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)
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