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)
- 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)
- 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)
- 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)
- 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)
- 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)
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