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- ‘I Owe A Debt Of Gratitude To America,’ Says FDA Staffer Whose Termination Was Rescinded (MedTech Insight)
- 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)
- 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)
- 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)
- 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)
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