Recon: Lilly stockpiles $1.5B of weight loss pill in advance of FDA approval; FDA rejects Disc Medicine’s porphyria drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Major shakeup underway at HHS as White House braces for midterms (STAT)
- America’s disease surveillance system is going dark. Here’s what we can build to replace it (STAT)
- Exit of CDC’s acting director highlights agency’s lack of leader (STAT)
- FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher (STAT)
- How a Company Makes Millions Off a Hospital Program Meant to Help the Poor (The New York Times)
- Doctors bear the burden as ‘medical freedom’ fuels worst US measles outbreak in 30 years (Reuters)
- US FDA Proposing White House-Aligned Policies For User Fee Agreements (Pink Sheet)
- Pentagon does quick about-face after adding WuXi AppTec to Chinese military list (Endpoints)
- Gilead gets cancer drug from China-based Genhouse for $80M upfront (Endpoints)
- Edwards Lifesciences scraps anti-copycat policy, EU drops antitrust investigation (Reuters)
- MHRA Runs CE-Marking Consultation Until April 10 (MedTech Insight)
- Dexcom Readies For Ireland Plant Coming Onstream In Q4 (MedTech Insight)
- SEISMIC Potential: Minimally Invasive Brain Surgery Project Shows Scope Of EU IHI Funding (MedTech Insight)
- Canada Seeks To Transform Clinical Trial Landscape With Flexible, Risk Based Rules (Pink Sheet)
- Eli Lilly builds $1.5 billion stockpile of weight-loss pill ahead of FDA decision (Reuters)
- Who Qualifies for the New FDA PreCheck Pilot Program? (FDA Law Blog)
- Exclusive: Feng Zhang’s epigenetic editing startup shifts focus to siRNA obesity therapies (Endpoints)
- Lundbeck's migraine prevention drug succeeds in Phase 2, advancing new therapy class (Endpoints)
- US FDA Refuse-To-File Letters Hit The Big Time With Moderna’s Flu Vaccine (Pink Sheet)
- Stallergenes to Drop Former Nestlé Peanut Allergy Pill Palforzia (Bloomberg)
- Moderna is noncommittal on 2028 break-even guidance, with flu shot future in flux (Endpoints)
- Virtual Cell Models Show Promise, But Regulators Must Decide How To Measure Accuracy (Pink Sheet)
- FDA Approves First Home-Use Pancreatic Cancer Treatment Device (MedTech Insight)
- Novocure wins FDA approval to treat pancreatic cancer with electric fields (MedTech Dive)
- Dexcom seeks expanded Medicare coverage of CGMs for Type 2 diabetes (MedTech Dive)
- Siemens Healthineers, Mayo Clinic partner on neurodegenerative disease, cancer (MedTech Dive)
- Edwards To Launch Surgical LAAC In 2026 As Structural Heart Expansion Accelerates (MedTech Insight)
- From Industry To Regulator And Back: Segan Talks Life After CDRH (MedTech Insight)
- Kennedy says he’ll act on legal challenge to ultra-processed foods (STAT)
- Lilly appeals ruling over retatrutide classification in case that could impact compounders (Endpoints)
- In court, AAP argues Kennedy’s HHS made unlawful changes to vaccine policies (STAT)
- Pharmacist oversight must be built into prescription kiosks (STAT)
- How pediatricians found themselves at war with RFK Jr. (STAT)
- Breakup between Brigham and Dana-Farber is getting messier fast (STAT)
- How public health saved the CDC Injury Center (STAT)
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