Recon: Lilly stockpiles $1.5B of weight loss pill in advance of FDA approval; FDA rejects Disc Medicine’s porphyria drug

• 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)