rf-fullcolor.png

 

February 24, 2025
by Jason Scott

Recon: Cavazzoni returns to Pfizer as CMO; SK Capital to acquire Bluebird Bio for below $30M

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

In Focus: US
  • US FDA asks fired scientists to return, including some reviewing Musk’s Neuralink (Reuters)
  • Musk's demand to government workers opens fissures in Trump administration (Reuters)
  • Trump Told Drugmakers to Move Production to US or Face Tariffs (Bloomberg)
  • An awkward moment for Pfizer’s Bourla in Washington (STAT)
  • Bluebird Bio sells itself to Carlyle, SK Capital for less than $30 million (STAT)
  • Pfizer hires ex-FDA deputy Patrizia Cavazzoni as chief medical officer (Endpoints) (Reuters)
  • FDA approves first drug to treat ultra-rare lipid storage disease (Endpoints)
  • CBER's deputy director departs as staff shakeup continues (Endpoints)
  • ‘I Owe A Debt Of Gratitude To America,’ Says FDA Staffer Whose Termination Was Rescinded (MedTech Insight)
In Focus: International
  • Amgen plans further $200M investment in new tech facility in India (Endpoints)
  • Saudi Arabia confirms $500 million commitment to polio eradication effort, WHO says (Reuters)
  • New German Government Told To Keep Medtech Outside Tariffs Bargaining (MedTech Insight)
  • PhRMA Kicks Off Year Attacking China, Wrapping Agenda In American Flag (Pink Sheet)
  • IGBA Picks Apart Innovator Patent ‘Gaming Systems’ (Pink Sheet)
  • Fueled by pandemic frustrations, populist parties are embracing anti-vaccine figures overseas, too (STAT)
Pharma & Biotech
  • Post-Hoc: Pharma CEOs' alternative reality with Trump (Endpoints)
  • Pfizer wants in on Summit’s goal to beat Keytruda via ADC combos (Endpoints)
  • Sanofi, Teva bolster case for IBD drug with Phase 2 data, despite potential competition (Endpoints)
  • Teva launches Stelara biosimilar at 85% discount as wider field emerges (Endpoints)
  • PMCPA brings the buzzkill to LinkedIn celebration, laying into GSK over employee’s clicks (Fierce Pharma)
  • Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' fourth quarter (Fierce Pharma)
  • Pfizer discontinues hemophilia treatment Beqvez, emptying its gene therapy portfolio (Fierce Pharma)
  • After asset purchase from Travere, Mirum's Ctexli crosses FDA finish line in rare metabolic disorder (Fierce Pharma)
  • Abbott's stigma-busting campaign shows how diabetes biases lead to silence, skipped care (Fierce Pharma)
Medtech
  • What diagnostic tests can teach about spotting public fraud (STAT)
  • US FDA approves Medtronic's medical device for Parkinson's disease (Reuters)
  • VitalConnect raises $100M for heart monitor patch (MedTech Dive)
  • After tough year, Baxter looks for next CEO to drive growth (MedTech Dive)
  • Warning Letters: An Untapped Source for Understanding When Device Changes Require a New 510(k) (FDA Law Blog)
Government, Regulatory & Legal
  • Maryland lawmakers vote to expand powers of the state’s prescription drug affordability board (STAT)
  • Federal judge extends restraining order on Trump administration’s cap on NIH indirect costs (STAT)
  • US health agencies delay decision on definition of 'healthy' on food labels (Reuters)
  • MAHA Commission: Will Conclusions Arrive By The Deadline? Internal Panel Has Aggressive Mandate (Pink Sheet)
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.