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May 22, 2025
by Jason Scott

Recon: MAHA report blames diet, prescription drugs as causes of chronic illness; FDA adcomm votes against Pfizer's prostate cancer combo

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

In Focus: US
  • Trump administration proposes cutting Food and Drug Administration budget by 5.5% (Reuters)
  • In a significant change, House GOP tax cut bill would start Medicaid work requirements next year (STAT)
  • House Republicans pass ‘big, beautiful bill’ after weeks of division (Politico)
  • RFK Jr. Report Blames Diet, Overmedication for Chronic Diseases (Bloomberg) (Axios) (NYTimes)
  • Five burning questions on the FDA’s new Covid-19 vaccine framework (STAT)
  • Prices for new US drugs doubled in 4 years as focus on rare disease grows (Reuters)
  • FDA adcomm votes unanimously against Pfizer's prostate cancer drug combo (Endpoints)
  • Teva, Novartis get fresh warnings from FTC over Orange Book patent listings (Endpoints)
  • The FDA’s New Covid Vaccine Policy Is Clear as Mud (Bloomberg)
  • FDA announces efforts to facilitate drug importation from Canada (Endpoints)
  • Moderna pulls application for COVID-flu combination shot (Reuters)
In Focus: International                                                                                                       
  • Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out (Pink Sheet)
  • Global vaccine and health bodies could team up more to tackle US-led funding crisis (Reuters)
  • ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials (Pink Sheet)
  • Zentiva inks €220M deal for former AstraZeneca GI drug in Europe (Fierce Pharma)
  • India's Sun Pharma posts bigger adjusted profit on demand for rare disease drugs (Reuters)
  • India's Mankind Pharma beats profit estimates on demand for drugs to treat chronic illnesses (Reuters)
Pharma & Biotech
  • Novo Offers Wegovy at $199 for First Month as Copycats End (Bloomberg)
  • Novo Nordisk's former chief makes comeback to steer choice of new CEO (Reuters)
  • Tourmaline drug cuts inflammation tied to heart disease (STAT)
  • Biotech investor activism is on the rise (STAT)
  • How do we know mRNA vaccines are safe and effective? An explainer (STAT)
  • The new era of individualized medicine requires a ‘genetic surgery’ system (STAT)
  • Sanofi makes $470M move for Vigil's Alzheimer's drug, while another asset returns to Amgen (Endpoints)
  • Samsung Biologics to separate manufacturing and biosimilar businesses (Endpoints)
  • Samsung Biologics, C&T Shares Volatile After Spin-Off Plan (Bloomberg)
  • FDA asks Covid vaccine makers to add more myocarditis data to labels (Endpoints)
  • Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor (Pink Sheet)
  • US CDC accepts recommendations for chikungunya vaccines (Reuters)
Medtech
  • ASCO and Google create ‘walled garden’ AI tool for doctors to query group’s guidelines (STAT)
  • Self-guided mental health apps can improve outcomes and lower costs, report finds (STAT)
  • Hinge Health is going public on Thursday at a $3B valuation (Endpoints)
  • AI-Generated Drugs to Reach Market by 2030, Says Insilico CEO (Bloomberg)
  • Cost cuts, production shifts: How medtech firms are managing tariffs (MedTech Dive)
  • Why Medtronic plans to spin out its diabetes business (MedTech Dive)
Food & Nutrition
  • Three big ideas to actually ‘Make America Healthy Again’ (STAT)
  • Kraft Heinz confirms $3B investment in US manufacturing (Food Dive)
  • Food industry fights for SNAP as program faces massive cuts (Food Dive)
  • Study: AI Can Predict Listeria Resistance to Cleaning Agents (Food Safety)
Government, Regulatory & Legal
  • Trump, building on Biden policy, to speed up audits of Medicare Advantage insurers (STAT)
  • LGBTQ+ researchers sue HHS, NIH over grant cuts (STAT)
  • Trump’s R&D Funding Cuts Create Job Drought for Scientists (Bloomberg)
  • One Analyst Saw the Dark Clouds Coming for UnitedHealth (Bloomberg)
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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