Recon: Supreme Court to hear arguments in mifepristone case on Tuesday; Novo Nordisk to buy Cardior Pharmaceuticals in $1.1B

• FDA approves first gene therapy for fatal neuron disease in children (STAT)
• FDA authorizes new drug to protect immune compromised from Covid-19 (STAT)
• Despite new Wegovy coverage, Medicare patients may face high drug costs and other hurdles (STAT)
• During the pandemic, were great vaccines bad business? A company-by-company review (STAT)
• SCOTUS’ abortion pill mifepristone case is really about the FDA (STAT)
• US Supreme Court abortion pill fight brings claims of distorted science (Reuters)
• The FDA in the Crosshairs—Science, Politics, and Abortion (JAMA)
• Understanding the Impacts of the Supreme Court Case FDA v Alliance for Hippocratic Medicine (JAMA)
• FDA rejects Regeneron's bispecific for lymphoma over confirmatory trial status (Endpoints)
• Esperion eyes new commercial push for cholesterol-lowering drugs after big FDA label expansion (Endpoints)
• Lead House sponsor of WuXi-linked bill to leave Congress early (Endpoints)

• What the public might learn from Kate Middleton, the latest ‘famous patient’ (STAT)
• Leqembi authorization in EU is delayed for procedural issues (Endpoints)
• Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee (Pink Sheet)
• Nearly 50 New And Revised EU MDR and IVDR Guidances In The Pipeline (MedTech Insight)
• Non-Medical Brain Stimulation Devices: Could They Be Down-Classified Again In the EU? (MedTech Insight)

• Novo Nordisk to acquire heart disease-focused Cardior Pharmaceuticals in deal worth $1.1 billion (STAT)
• AbbVie to buy Landos to expand pipeline of immunity-related illnesses (Reuters)
• BioNTech gets US agency notice over default on COVID vaccine royalties (Reuters)
• Axsome's sleep disorder drug succeeds in late-stage trial, shares rise (Reuters)
• Drug development was once a marathon. New tools and timelines are turning it into a sprint (STAT)
• J&J's Actelion buyout pays off again with approval of Opsynvi in pulmonary arterial hypertension (Endpoints)
• Patient advocates clash over wisdom of ‘approving drugs faster and faster’ (STAT)
• Return of the megarounds; Nvidia’s AI pitch to biotech; Bayer’s shakeup reaches the top; AstraZeneca buys into radiopharma; and more (Endpoints)
• Why Lenz picked a reverse merger instead of an IPO: Q&A (Endpoints)
• PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year (Pink Sheet)

• Nvidia says generative AI will revolutionize health care. So did IBM, with Dr. Watson (STAT)
• Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks (Pink Sheet)
• Vyaire Medical recalls Airlife resuscitators over defect linked to 2 death reports (MedTech Dive)
• As FDA’s LDT rule looms, experts warn patients may lose access to critical tests (MedTech Dive)
• J&J MedTech Partners With Nvidia To Expand AI In Surgery (MedTech Insight)

• Medicare Advantage insurers pressure Biden administration for bigger payments (STAT)
• FDA to delete 'You are not a horse' post and others in ivermectin case settlement (Endpoints)
• Senators push HHS on ‘inadequate’ response to Change Healthcare cyberattack (Endpoints)
• Bernie Gets Mostly Pharma-Friendly Drug Pricing Results (Pink Sheet)
• Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit (FDA Law Blog)