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April 29, 2025
by Jason Scott

Recon: Makary says FDA won't reorganize product centers; Merck to spend $1B on US factory to produce Keytruda

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

In Focus: US
  • How RFK Jr.’s vaccine criticism is taking hold at the FDA (STAT)
  • U.S. government researchers present ‘phenomenal’ new data on HPV vaccines (STAT)
  • FDA appears to be slow-walking vaccine approvals (NBC)
  • With one month to go, few details on RFK Jr.’s MAHA commission (STAT)
  • A proudly frugal tech CEO now runs Medicare, where he’ll hunt for savings on a far bigger stage (STAT)
  • Merck to Spend $1 Billion on New Factory to Make U.S. Supplies of Blockbuster Drug (The Wall Street Journal)
  • FDA won't reorganize medical product centers, Makary says in interview: 'I rejected that proposal' (Endpoints)
  • A Conversation With FDA Commissioner Marty Makary (MedPage)
  • US FDA chief says firings won't hinder agency's target dates for drug reviews (Reuters)
  • FDA to undo some layoffs, after cuts to inspections and drug safety (CBS)
In Focus: International                                                                                                       
  • AstraZeneca says potential US tariffs manageable, faces another China fine (Reuters)
  • Swiss drugmaker Novartis raises 2025 forecast after strong Q1 momentum (Reuters)
  • Gates, others launch $500 million maternal, newborn health fund, bucking aid cuts trend (Reuters)
  • “Come Early, Come Often,” EMA Chief Tells Industry (Pink Sheet)
Pharma & Biotech
  • Novo Nordisk strikes telehealth deals for obesity drug, following Eli Lilly (STAT)
  • The end of compounded GLP-1 copies leaves many patients in a ‘lose-lose’ position (STAT)
  • FDA approves Abeona’s skin disease cell therapy (Endpoints)
  • With a new CEO, oligonucleotide biotech Creyon forges Eli Lilly partnership (Endpoints)
  • AbbVie’s Rinvoq is approved in giant cell arteritis; Relmada shares bladder cancer data (Endpoints)
  • FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts (Endpoints)
  • Devoted Health shrank its operating losses in 2024 as revenue exploded (Endpoints)
  • AstraZeneca, Novartis execute ‘US for US’ strategy as pharma tariffs near (Endpoints)
  • Pfizer launches a new wave of cost cuts, expects $7.7B in total savings through 2027 (Endpoints)
  • Exclusive: Basil Systems raises $11.5M to help pharma navigate regulations (Endpoints)
  • Indivior-backed paper champions fast-acting overdose reversal meds against synthetic opioids (Fierce Pharma)
Medtech
  • ICU Medical receives FDA warning letter over infusion pumps (MedTech Dive)
  • Ashley McEvoy named Insulet CEO (MedTech Dive)
  • Roche Diagnostics Hit By China Reforms As Q1 Sales Remain Flat (MedTech Insight)
  • Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy (MedTech Insight)
Food & Nutrition
  • USDA withdraws plan to limit salmonella in raw poultry (Food Dive)
  • Shoppers expect to spend 8% more on groceries due to tariffs, survey finds (Food Dive)
  • A ‘new chapter’ for Chips Ahoy!: How Mondelēz is innovating the iconic cookie brand (Food Dive)
  • Food on the Move: Managing Hygiene and Safety Risks in Transport (Food Safety)
Government, Regulatory & Legal
  • Medicare regulations hamper providers without helping patients (STAT)
  • The future of preventive care depends on the Supreme Court’s reading of two words (STAT)
  • Trump’s first 100 days, seen through 5 lives: Grants terminated. Dreams crushed. Futures in the balance (STAT)
  • Amid FDA chaos, approval of a rare disease drug gets delayed — again (STAT
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.
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