rf-fullcolor.png

 

January 30, 2025
by Jason Scott

Recon: Takeda CEO Weber to step down; Merck halts PAH drug trial early on strong efficacy data

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

In Focus: US
  • Live updates: RFK Jr., Trump’s HHS pick, questioned on vaccine views at second confirmation hearing (STAT)
  • Kennedy says he will finalize rules that increase diversity in clinical trials (Reuters)
  • The 7 big topics RFK Jr. addressed during a fiery confirmation hearing (STAT)
  • RFK blog: Republican swing votes question Kennedy's vaccine stances (Endpoints)
  • Trump administration cancels meetings of health technology advisory committee (STAT)
  • Merck to stop lung condition drug study early due to strong efficacy data (Reuters)
In Focus: International                                                                                                       
  • Takeda CEO Christophe Weber to step down following prolonged drop in company shares (STAT)
  • Bright Green budgets $3.5B for new builds; European Commission opens biomanufacturing hub (Endpoints)
  • Is India’s Ban On Imports Of Refurbished Medical Devices Right Move? Industry Debates The Effects (MedTech Insight)
  • Biocon's Q3 revenue dips; banks on obesity drugs for future growth (Reuters)
  • Sanofi plans share buybacks, signals more deals post Opella sale (Reuters)
  • Roche sees high single-digit core profit growth in 2025 (Reuters)
  • Uganda confirms Ebola case in nurse in capital city (STAT)
Pharma & Biotech
  • When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities (FDA Law Blog)
  • Takeda scraps programs as it raises full-year guidance (Endpoints)
  • Cargo to lay off staff after CAR-T data show safety concerns (STAT)
  • MASH drugs reach a meaningful tipping point for patients and investors (STAT)
  • Hims is making its Super Bowl debut with an ad that goes straight for pharma (Endpoints)
  • Blackstone secures $1.6B so far for new life sciences fund targeted at $5B+ (Endpoints)
  • Rentschler exits cell and gene business due to low demand, will prioritize biologics (Endpoints)
  • Ironwood's layoffs; Shionogi’s RSV pill succeeds in Phase 2 (Endpoints)
  • Tectonic gets Phase 1b win in heart condition where Eli Lilly recently failed (Endpoints)
  • 8VC, a tech and life sciences VC firm behind Altos Labs, eyes $1B fund (Endpoints)
  • Roche aims for derisked deals and ruthless portfolio cuts in 2025 (Endpoints)
  • Novo Nordisk says it has not yet posted details about new CagriSema trial (Reuters)
Medtech
  • Thermo Fisher sees robust 2025 profit on improved demand for its tools and services (Reuters)
  • Quest beats quarterly estimates on strong diagnostic test demand (Reuters)
  • What models flourished in the first generation of health tech? (STAT)
  • How AI helps drug developers skirt pharma’s ‘dirty little secret’ (STAT)
  • Engineered muscle patch fixed failing hearts in an early study (STAT)
  • How Define Ventures thinks health tech startups will exit in 2025 (Endpoints)
  • 4 robotic surgery trends to watch in 2025 (MedTech Dive)
  • 23andMe considers sale as cash runs low (MedTech Dive)
  • Acting Commish Brenner May Bring IT Focus (MedTech Insight)
Government, Regulatory & Legal
  • What I learned about health insurance rage as the nation’s first ‘HMO czar’ (STAT)
  • Private emails show RFK Jr. making false claims about Covid-19 shots, linking vaccines to autism (STAT)
  • Universities fear Trump is using lucrative research grants as leverage to dismantle their DEI programs (Endpoints)
  • Despite waiver from U.S. on aid freeze, health and humanitarian groups uncertain if they can proceed (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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.