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July 7, 2025
by Michael Mezher

Recon: Medical societies sue HHS over vaccine policy; FDA approves KalVista’s swelling disorder drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Medical groups sue HHS, Kennedy over vaccine policy (Reuters) (NYTimes)
  • US FDA approves KalVista's oral swelling disorder drug, shares rise (Reuters)
  • FDA chief calls for 'meaningful' reduction of animal testing for new drugs (Endpoints)
  • HHS actions to remove web content were arbitrary, 'poorly thought-through,' judge rules (Endpoints) (Pink Sheet)
  • FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say (ProPublica)
  • Drugmakers Notch a $5 Billion Win in Republicans’ Policy Bill (NYTimes)
  • US measles cases hit 6-year high at 1277 cases, John Hopkins data shows (Reuters)
In Focus: International
  • Italy set to speed through $2.3 billion Novo Nordisk investment (Reuters)
  • China retaliates against EU ban with import restrictions on medical devices (Reuters)
  • Compromised drug lot impacts Jasper's chronic hives study, stock falls (Endpoints)
  • European Commission fines Alchem, closes API ‘cartel’ investigation (Endpoints) (EC)
  • European Hospital Products Sourced Through ‘System That Rewards Exploitation,’ Watchdog Finds (MedtechInsight)
  • Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline (Pink Sheet)
  • England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal (Pink Sheet)
Pharma & Biotech
  • Boston’s biotech sector reels due to Trump health policy uncertainty (Financial Times)
  • Patients with ultra-rare diseases worry FDA approach will leave them without treatment (The Guardian)
  • Adaptive Clinical Trials Require ‘Clear And Compelling Justification’ (Pink Sheet)
  • Apogee touts positive data for atopic dermatitis drug (BioPharmaDive)
  • Denali's Hunter syndrome therapy gets priority review; LENZ inks Canada deal (Endpoints)
  • Roche-backed Chugai taps into longevity field with Pfizer-allied Gero (Endpoints)
  • Study results boost Cogent’s case for rare disease drug (BioPharmaDive)
  • Here At Last: Canada’s Long-Contested Guidelines For Curbing Excessive Drug Prices (Pink Sheet)
Medtech
  • Planning To Take Part in MDUFA? FDA Wants To Hear From You (MedtechInsight)
  • Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations (MedtechInsight)
  • Baxter International taps Andrew Hider as CEO (Reuters)
  • Aktiia gets FDA clearance for OTC cuffless blood pressure monitor (Mobihealthnews)
  • J&J’s Abiomed recalls heart pump controllers after 3 patients die (MedtechDive)
  • FDA clears Fasikl's AI neurostimulation wristwatch for essential tremor (Fierce)
  • Intuitive’s da Vinci 5 robot bound for Europe after CE Mark approval (Fierce)
Food & Nutrition
  • Chocolate Recall Update as FDA Sets Risk Warning (Newsweek)
  • FDA upgrades blueberry recall to highest risk level (The Hill)
  • FDA steps up enforcement of imports including soft cheese, seafood and cantaloupe (Food Safety News)
Government, Regulatory & Legal
  • Explainer: Key healthcare provisions in Trump's tax bill (Reuters)
  • Healthcare groups blast passing of Trump's tax bill, warn it will harm millions (Reuters)
  • Historic Medicaid cuts to come as Trump signs domestic policy bill (MedtechDive)
  • States Brace for Reversal of Obamacare Coverage Gains Under Trump’s Budget Bill (KFF Health News)
  • Implant Co. Sues Zimmer Biomet In Del. Over Milestone Miss (Law360)
  • Genentech's $122M MS Drug Royalties Case Ends In Mistrial (Law360)
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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