Recon: CMS unveils second list of drug price negotiations; Tarver warns on device supply chain vulnerabilities
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Medicare announces plan to negotiate prices of diabetes, weight loss drugs (STAT) (Endpoints)
- Biden pardons Fauci to preempt possible charges when Trump takes office (STAT)
- AstraZeneca, Daiichi Sankyo win first U.S. approval for key cancer drug (STAT)
- Trump finally finds a populist health care message in Kennedy’s MAHA (STAT)
- Online marketing for compounded GLP-1 drugs overstates benefits and underplays risks (STAT)
In Focus: International
- Another US biotech emerges with drug candidate from China-based Keymed (Endpoints)
- WuXi AppTec sells medical device testing unit; Layoffs at Notch Therapeutics (Endpoints)
- EU plans ban on 'forever chemicals' in consumer products (Reuters)
- India's Biocon urges government to exempt cancer, rare-disease drugs from tax in budget (Reuters)
- Fierce Pharma Asia—AbbVie's $1B pact with Simcere; Takeda's launch map; Samsung Bio's growth plans (Fierce Pharma)
Pharma & Biotech
- Studies reveal a new biology of Huntington’s, renewing drugmaker interest in therapies (STAT)
- Sage sues Biogen days after $469M buyout offer (Endpoints)
- Novo claims high-dose Phase 3 Wegovy win but sales impact might be muted (Endpoints)
- JPM25: Acadia’s new CEO sets sights on company's first $1B year (Fierce Pharma)
- Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto (Fierce Pharma)
- AstraZeneca's Calquence and Amgen's Lumakras clinch FDA label expansions (Fierce Pharma)
- Arvinas' inaugural commercial chief steps down, to be replaced in the interim by market access VP (Fierce Pharma)
- Analysts tip Eisai, Biogen and Lilly to drive eightfold explosion in Alzheimer's market value (Fierce Pharma)
Medtech
- Tarver warns that US device supply chain vulnerabilities could harm patients (MedTech Dive)
- BD expands syringe, needle production capacity in Nebraska and Connecticut (MedTech Dive)
- UK NHS Must Capture Data For Next Generation Of AI In Healthcare (MedTech Insight)
- EU Launches First Specific Plan On Cybersecurity For Healthcare Providers (MedTech Insight)
Government, Regulatory & Legal
- Dementia risk, higher than thought, requires a national strategy (STAT)
- Former Trump health official: Medicare should cover Wegovy — but not negotiate its price (STAT)
- Former surgeon general: Vaccine-preventable diseases are still a major threat (STAT)
- Biden administration moves to expand, preserve access to addiction treatments as term expires (STAT)
- US and Canada ease ban on French poultry imposed after bird flu vaccination (Reuters)
- Exclusive: Kennedy played key role in Gardasil vaccine case against Merck (Reuters)
- Feds accuse Walgreens of filling ‘millions’ of illegal opioid prescriptions (STAT)
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.
