rf-fullcolor.png

 

February 6, 2025
by Jason Scott

Recon: Trump preparing order to cut federal health workforce; J&J inks $14B deal with Intra-Cellular

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

In Focus: US
  • White House Preparing Order to Cut Thousands of Federal Health Workers (WSJ) (Reuters)
  • The CRISPR companies are not OK (STAT)
  • Letter to FDA’s Office of Prescription Drug Promotion, CDER (The Partnership for Safe Medicines)
  • J&J, Intra-Cellular quickly sealed $14B deal as three others passed on buying the neuro drugmaker (Endpoints)
  • Trump team considers demanding WHO reform, including American in charge (Reuters)
  • Trump faces pressure from US industry over China tariff on medicines (Reuters)
  • HHS Website Went Down Following Communications Freeze (Bloomberg)
In Focus: International                                                                                                       
  • Argentina says it will withdraw from the World Health Organization, echoing Trump (STAT)
  • AstraZeneca takes $753M charge on abandoned complement drug from Alexion deal (Endpoints)
  • Africa's top health official presses US to resume health aid (Reuters)
  • AstraZeneca shares rise as China probe update reassures (Reuters)
  • IHH Healthcare's unit seeks up to $1.25 billion from Japan's Daiichi over Fortis deal (Reuters)
  • Modified Dermatology App Now Escapes Ban As German Court Cases Continue (MedTech Insight)
  • A $50B Market in Waiting: Medtech Trends To Watch Out For In 2025 In India (MedTech Insight)
Pharma & Biotech
  • CAR-T cells can arm other immune cells with engineered proteins to fight cancer, study says (STAT)
  • Previewing Immunovant’s myasthenia gravis study readout — with all its quirky nuance (STAT)
  • Personalized cancer vaccine shows potential in kidney cancer (STAT)
  • Pfizer hires Novartis oncology exec to steer its cancer ambitions (Endpoints)
  • Bristol Myers launches fresh round of major cost cuts in bid to get ahead of patent cliff (Endpoints)
  • AffyImmune’s layoffs; Henlius makes a biosimilar deal with Dr. Reddy’s (Endpoints)
  • Lilly's profit forecast bring investors some relief amid Zepbound miss (Reuters)
  • Becton looks to separate biosciences and diagnostic solutions after upbeat quarterly results (Reuters)
  • Wegovy maker Novo Nordisk says surging growth driving emissions higher (Reuters)
  • Bausch + Lomb Sale Stumble Frustrates Bausch Health Investors (Bloomberg)
Medtech
  • New Teladoc, same acquisition strategy (STAT)
  • Digital health dealmaking is heating up (Endpoints)
  • Siemens Healthineers says it would welcome stake reduction by Siemens (Reuters)
  • Zimmer touts ASC opportunity with Paragon 28 purchase (MedTech Dive)
  • AHA joins call for Trump to exempt devices from import tariffs (MedTech Dive)
  • Medtronic’s Orleigh Bogle on changing the culture of surgical training (MedTech Dive)
  • Boston Scientific closes its year of PFA on a high note (MedTech Dive)
  • Illumina placed on China’s unreliable entity list (MedTech Dive)
  • Pulse Biosciences names new CFO, continuing string of C-suite changes (MedTech Dive)
  • Legal Overview Of MDR’s ‘Overly Broad And Vague Article 10a’ (MedTech Insight)
  • US FDA’s Absence Raises Concerns In International Standards Development (MedTech Insight)
Government, Regulatory & Legal
  • USDA milk testing shows different strain of H5N1 bird flu in Nevada dairy herds (STAT)
  • We are all complicit in the big lie of health insurance (STAT)
  • FDA clinical trial inclusivity guidelines will be back (STAT)
  • What happens when a rare disease drug seems to work, but the health care system doesn’t? (STAT)
  • FDA Tissue Biopsy Draft Guidance Could Boost Liquid Biopsy Adoption In Clinical Trials (MedTech Insight)
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.