Recon: Work stalls after FDA staff cuts; Indian medtechs react to US tariff plans
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Drug Development Is Slowing Down After Cuts at the FDA (WSJ, Bloomberg Law)
- HHS funding slashed by 30 percent in budget proposal (Politico, STAT)
- UnitedHealth cuts profit outlook by $3 billion as more Medicare patients get care (STAT)
- Supreme Court to hear challenge to ACA rule requiring free preventive care, cancer screenings (STAT)
- Exclusive: US consumer safety agency to stop collecting swaths of data after CDC cuts (Reuters)
In Focus: International
- Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform (Pink Sheet)
- Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last (Pink Sheet)
- Indian Medtechs Call US Tariffs A Challenge To Growth And Seek Reciprocal Regulatory Access (MedTech Insight)
- Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times (MedTech Insight)
- Daily pill from Eli Lilly helps patients control blood sugar, lose weight, Phase 3 study shows (STAT)
- AstraZeneca unit sued over alleged monopoly on blockbuster drug Soliris (Reuters)
- Sarepta loses CMO to RNA editing upstart; Another wave of personnel moves at Dyne (Endpoints)
- Bayer lobbies US states in battle to keep glyphosate on market, CEO says (Reuters)
- US CDC advisers recommend lowering the age for RSV shots to 50-59 years (Reuters)
Medtech
- Big changes coming to federal health IT regulator? (STAT)
- RadNet leaders discuss rationale behind blockbuster $103M iCAD AI acquisition (Radiation Business)
- Medical device maker Belluscura expects 20% tariff on products sold in US (Reuters)
- A judge blocked the FDA’s plan to regulate LDTs. What now? (MedTech Dive)
- J&J’s electrophysiology sales dip amid slow Varipulse start (MedTech Dive)
- DaVita hit by ransomware attack (MedTech Dive)
- Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations (MedTech Insight)
- Guidance Comments Highlight Outstanding Questions In AI Development (MedTech Insight)
- Baby food makers are failing California’s lead standards, Reuters review shows (Reuters)
- How food giants are embracing AI to forecast recipes, regulatory hurdles (Food Dive)
- PepsiCo, Kraft Heinz face off with shareholder activists on sustainable packaging (Food Dive)
Government, Regulatory & Legal
- Arkansas adopts first-in-the-nation law forcing companies to choose between running a PBM or pharmacies (STAT)
- What it took for Walgreens to go private (Endpoints)
- Health insurer Elevance sees first-quarter profit above estimates (Reuters)
- Trump's Plan to Lower Drug Prices Takes Aim at IRA 'Pill Penalty' (MedPage Today)
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
