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)
- 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)
- 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)
- 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)
- 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)
- 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)
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