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May 8, 2025
by Jason Scott

Recon: Verastem's ovarian cancer drug gets FDA approval; PhRMA blasts tariffs as industry trade probe comments end

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

In Focus: US
  • New CBER Director Vinay Prasad praises evidence, FDA reviewers in first speech to staff (STAT)
  • Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA (STAT)
  • Trump to pitch sweeping Medicare drug price plan (Politico)
  • US FDA approves Verastem's ovarian cancer therapy (Reuters)
  • Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list (STAT)
  • Francis Collins blasts Trump administration’s ‘slash-and-burn’ actions at science agencies (STAT)
  • Trump nominates Casey Means, entrepreneurial doctor and MAHA leader, for surgeon general (STAT)
  • PhRMA says tariffs are 'not the answer' as industry trade probe closes for comments (Endpoints)
  • Trump administration health research cuts total $1.8 billion, analysis finds (Reuters)
In Focus: International                                                                                                       
  • Bill Gates to accelerate spending at his foundation — then wind it down (STAT)
  • Bristol Myers' $40B US investment; Shionogi to buy Japanese drugmaker (Endpoints)
  • UK court upholds watchdog's finding on excessive NHS thyroid drug prices (Reuters)
  • EU drugs regulator confirms suicidal thoughts as side effect of hair loss drug (Reuters)
  • EU sets out possible 95-billion-euro response to US tariffs (Reuters)
Pharma & Biotech
  • Trump signs order in bid to boost pharma manufacturing in the U.S. (STAT)
  • The state of antibiotic development: ‘Deplorable comes to mind’ (STAT)
  • 'Find a way, or make one': How two scientists hope to revitalize CRISPR's rare disease crisis (Endpoints)
  • HAYA Therapeutics gets $65M for 'dark genome' work following last year's Lilly pact (Endpoints)
  • Blood cancer biotech Vor Bio ends clinical work, lays off 95% of staff (Endpoints)
  • Lantheus culls late-stage Lilly-partnered prostate cancer radioligand (Endpoints)
  • ALX Oncology won’t seek approval for CD47 drug in gastric cancer; Korro Bio’s layoffs (Endpoints)
  • Gilead reveals plans to put another $11B into US manufacturing (Endpoints)
  • Teva plans staff cuts as it commits to accelerating growth (Endpoints)
  • Novavax says talks with FDA on COVID vaccine approval ongoing calming investor fears (Reuters)
  • Kenvue expects flat profit as $150 million tariff hit looms (Reuters)
  • Hikma Pharma to pay $50 million to settle narcolepsy drug antitrust case (Reuters)
Medtech
  • Masimo finds buyer for consumer audio business (MedTech Dive)
  • Siemens Healthineers lowers earnings forecast on expected tariff hit (MedTech Dive)
  • Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector (MedTech Insight)
  • State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment (MedTech Insight)
  • Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty (MedTech Insight)
Food & Nutrition
  • PepsiCo taps Amazon Web Services to accelerate digital transformation, AI adoption (Food Dive)
  • FDA Releases CORE 2023 Annual Report regarding Investigations of Foodborne Outbreaks (Food Safety)
Government, Regulatory & Legal
  • Cancer before age 50 is increasing. A new study looks at which types (STAT)
  • RFK Jr. wants Americans’ health records to study autism. It’s not that easy to get them (STAT)
  • Inside the world of internet peptides (STAT)
  • An evidence-based way to make Medicaid less bureaucratic and more efficient (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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