Recon: Appeals court ruling would limit access to abortion pill; Ipsen’s ultra-rare bone disease drug nabs FDA approval

• Boehringer Initiates Phase III Obesity Trials, Seeks to Challenge Novo and Lilly (BioSpace)
• FDA Approves Ipsen’s Palovarotene for Ultra-Rare Bone Disease (BioSpace) (STAT)
• Federal Appeals Court Rules for Tighter Restrictions on Abortion Pill (BioSpace) (STAT) (Reuters)
• How Dozens of Websites Sell Knock-Off Drugs, No Prescription Required (The Wall Street Journal)
• Few patients may qualify to get new Alzheimer’s drugs, study suggests (NBC News)
• States cry foul at Lilly's $13.5 mln insulin class action settlement (Reuters)
• Blue Shield of California looks to cut reliance on CVS, taps Amazon (Reuters)
• Lilly's $13.5M insulin pricing settlement gets pushback from 9 states (Fierce Pharma)
• Medicare Price Negotiation List Remains A Puzzle, Even For Those That Are (Probably) On It (Pink Sheet)

• South Africa ordered to disclose contracts with Pfizer, J&J, and other Covid-19 vaccine suppliers (STAT)
• Roche's SMA drug 15x costlier in India than in China & Pakistan (Times of India)
• I-Mab to seek approval of pediatric growth hormone deficiency drug in China next year after PhIII win (Endpoints)
• Brazilian Regulator Creates New Committee To Take Part In Drug Approvals (Pink Sheet)
• EMA Probe Into Paternal Valproate Exposure Risk Continues After ‘Errors’ Found In Study (Pink Sheet)
• Canada To Start Temporarily Reimbursing Drugs That Need More Evidence (Pink Sheet)

• Chimerix’s Drug Candidate Improves Survival for Patients with Incurable Brain Tumor (BioSpace)
• Intellia, Verve run clinical trials abroad amid FDA’s ‘cautious’ approach to gene editing (Endpoints)
• Selecta Biosciences is narrowing its focus (Endpoints)
• Abcuro reels in $155M to test antibody's potential in rare muscle disease, setting biotech's 2026 BLA plans (Endpoints)
• Valneva tops up loan by $100M; Ipsen gets a voucher (Endpoints)
• SPAC Ashington Innovation plans to acquire dormant biotech Celixir and lead heart failure program for $172M (Endpoints)
• GSK stays a step ahead in RSV vaccine battle as Arexvy becomes available at US pharmacies (Fierce Pharma)
• With trial win, Seagen's breast cancer drug Tukysa boosts Roche's Kadcyla—and Pfizer’s $43B buyout (Fierce Pharma)

• UPDATE: US FDA Walks Back OST Reorg Announcement (MedTech Insight)
• Cybersecurity Expert Says eSTAR Requirement Will Push FDA, Industry In Positive Direction (MedTech Insight)
• Minute Insight: Hyfe Goes Physical With Wearable Partnership (MedTech Insight)
• Discard Diagnostics From Universal Meditech, FDA Warns (MedTech Insight)
• Integra receives warning letter related to quality issues at Boston plant (MedTech Dive)
• Edwards software linked to improved blood pressure control during surgery (MedTech Dive)
• 23andMe rival warns consumer test approach misses 90% of cancer variants (MedTech Dive)
• One death, 2 injuries reported in recall of Philips Trilogy ventilators (MedTech Dive)
• Medtronic’s dialysis device recall assigned to Class I by the FDA (MedTech Dive)
• GE HealthCare wins FDA clearance for wireless hospital vital sign monitor (MedTech Dive)

• AdaptHealth says incoming CEO sued by former employer Linde (Reuters)
• His tiny prenatal testing company has big plans after exacting legal revenge on lab giants (Endpoints)
• Teva's trial in high-stakes kickbacks case delayed as company pursues rare pretrial appeal (Fierce Pharma)
• Valisure Aims To Show DOD, Others Which Generics Are Best In NDC Screening And Color-Coding Pilot (Pink Sheet)