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)
- 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)
- 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)
- 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)
- 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)
- 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)
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