Recon: CSL to invest $1.5B on US drug production; FDA approves Arrowhead’s Redemplo for rare genetic disorder
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA approves Arrowhead's genetic disorder drug (Reuters)
- How RFK Jr., America’s celebrity health secretary, is steamrolling science (STAT)
- FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk (STAT)
- NIH funding cuts have affected over 74,000 people enrolled in experiments, a new report says (Associated Press)
- Drugmakers say HHS' 340B pilot is limited as they fight for their own rebate models (Endpoints)
- Australia’s CSL to Invest $1.5 Billion on US Drug Manufacturing (Bloomberg)
- Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds (STAT)
- Trump administration touts moves to provide HIV prevention drug, but refuses to include South Africa (STAT)
- First doses of HIV prevention drug lenacapavir delivered to Zambia, Eswatini (Reuters)
- New US trade deal caps Switzerland, Liechtenstein pharma tariffs at 15% (Endpoints)
- WHO to lose a quarter of its workforce by mid-2026, document shows (Reuters)
- Novo Holdings exits UK's Convatec after discounted share sale, bookrunner says (Reuters)
- SixPeaks CEO talks about $170M sale to AstraZeneca and what comes next in obesity (Endpoints)
- Exclusive: Lifordi gets new funding from Sanofi as it preps to test ADC in rheumatoid arthritis (Endpoints)
- Merck, Bristol Myers disclose layoffs in New Jersey (Endpoints)
- Roche’s oral SERD delays early breast cancer recurrence in late-stage trial (Endpoints)
- Merck advances Winrevair in subset of heart failure patients (Fierce Pharma)
- Exclusive: Thrivory raises $3.5M to help clinics get paid upfront within seconds (Endpoints)
- Exclusive: AI Proteins raises $42M Series A, and will launch miniproteins into hub-and-spoke model (Endpoints)
- Vanda says its drug can halve vomiting risk in patients using GLP-1s (Endpoints)
- Zymeworks and Jazz tout HER2 bispecific success in first Phase 3 readout (Endpoints)
- Pfizer Eyes $5 Billion High-Grade Bond Sale for Metsera Deal (Bloomberg)
- Regeneron to invest $2B in new Saratoga Springs production plant (Fierce Pharma)
- FDA clears spinal cord stimulator for home use (STAT)
- Medtronic raises annual sales growth forecast on heart devices demand (Reuters)
- Medtronic’s PFA business is heating up (MedTech Dive)
- Massive PAD Patient Study Finds No Enhanced Risk From Drug-Coated Devices (MedTech Insight)
- Boston Scientific, Siemens Healthineers partner on cardiac catheter (MedTech Dive)
- As wellness trends go upscale, Nestle's mass-market vitamins lose some shine (Reuters)
- Food and beverage trends loom large over packaging earnings (Food Dive)
- Cassidy pitches his alternative to extending extra ACA subsidies (STAT)
- Trump Tells Congress Don’t ‘Waste’ Time on Obamacare Credits (Bloomberg)
- Trump and RFK Jr. are mulling their most disruptive vaccine policies yet — alarming manufacturers (STAT)
- UnitedHealth names former US FDA chief Scott Gottlieb to its board (Reuters)
- Republican Support for Key Childhood Vaccines Is Backsliding (Bloomberg)
- FDA takes issue with AstraZeneca TV ad for Farxiga (Fierce Pharma)
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