Recon: Supreme Court preserves access to mifepristone for now; After long delays, FDA approves Medtronic’s insulin pump

• Supreme Court maintains access to abortion pill mifepristone, at least for now (STAT) (Washington Post) (Endpoints)
• Supreme Court’s Abortion Pill Call Leaves FDA in Line of Fire (Bloomberg)
• Bluebird submits sickle cell gene therapy to FDA for approval (STAT) (Reuters) (Biopharma Dive)
• Foghorn muted again as FDA places partial clinical hold on second cancer drug trial (Fierce) (Reuters) (Endpoints)
• FDA lifts nearly two-year hold on MaaT Pharma's microbiome therapy, opens door to PhIII (Endpoints) (Fierce)
• FDA Delays Verdict for Daiichi Sankyo’s Quizartinib (BioSpace) (Endpoints)
• CBER to Launch Operation Warp Speed for Rare Diseases by Year’s End (BioSpace)
• Applied Therapeutics fails phase 3 rare disease trial but plans to seek approval anyway (Fierce)
• Amid Pluvicto shortage, FDA quickly clears Novartis manufacturing facility (Fierce) (Endpoints)
• US FDA Expands Options For Product-Specific Guidance Meetings With ANDA Sponsors (Pink Sheet)
• Q&A: Chronicling the failures of the U.S. response to Covid (STAT)
• The new face of Alzheimer’s: Early stage patients who refuse to surrender (Washington Post)

• ‘A tug of war’: Europe braces for new legislation with far-reaching impacts on pharma and patients (STAT)
• EMA Decision Time For GSK’s RSV Older Adult Vaccine & Roche’s Glofitamab For LBCL (Pink Sheet)
• EMA Makes Progress On Real-World Evidence ‘Use Cases’ With HTA Bodies & Payers (Pink Sheet)
• International Regulators’ Consortium Offers Joint Pipeline Discussions With Pharma (Pink Sheet)
• MFDS Forum Highlights Korea’s Shift To Regulatory Science Approach (Pink Sheet)
• Australia Cuts Reimbursement Decision Times & Boosts Submission Success Rates (Pink Sheet)
• Serum Institute of India in talks to secure a fill-finish deal for the Oxford malaria vaccine in Ghana (Endpoints)
• How small vaccine stockpiles can stop outbreaks of infectious disease from becoming big (STAT)

• See you later, Baqsimi: Lilly sells low blood sugar rescue treatment to Amphastar for $500M-plus (Fierce) (Reuters) (Endpoints)
• In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk’s Wegovy (Fierce) (Medwatch)
• Ionis and AstraZeneca Seek to Challenge Alnylam with New ATTR Data (BioSpace) (Fierce)
• A ‘blistering’ start to M&A in 2023 stokes hopes of a market rebound, as insiders predict a surge in deals (Endpoints)
• ‘Slow start’ to UK biotech investment in 2023 as companies ‘work harder’ for funding: report (Fierce)
• Unity’s eye disease med passes extended phase 2 test, with Eylea battle on the horizon (Fierce)
• Accel Research expands reach with acquisition of two Florida trial sites (Fierce)

• Medtronic’s MiniMed 780G insulin pump lands long-awaited FDA approval (Fierce) (MedTech Dive) (Bloomberg)
• Rejected Again: Advisory Panel Votes Against De Novo Approval For Tennessee Company’s Knee Implant (MedTech Insight)
• US FDA identifies recall of Avanos Medical's respiratory systems as most serious (Reuters)
• Ten Expert Panel Opinions Published: What Lessons Can Industry Learn? (MedTech Insight)
• Philips shares jump on recall provision and profit improvement (Reuters)
• Thermo Fisher Inks Deal With Devyser To Sell Post-Transplant Diagnostics (MedTech Insight)
• Boston Scientific weighing deal to buy Shockwave Medical, Bloomberg reports (Reuters)
• Alphatec offers $55M to acquire robotic navigation system from Accelus amid 52% revenue growth (Fierce)
• Tales from HIMSS23: Care In The Metaverse (MedTech Insight)
• Paragonix’s organ transport hardware shows gains in heart, lung transplants (Fierce)

• Abortion Pill Maker’s Suit Proceeds Against West Virginia Ban (Bloomberg)
• Arizona Abortion Providers Push to Revive Reason Ban Lawsuit (Bloomberg)
• Drugmakers take sides in Amgen, Regeneron fight over antibody patents (BioPharma Dive)
• J&J Unit Loses Bid to Dismiss Tylenol-Autism Warning Lawsuit (Bloomberg)
• Lawsuit accuses J&J subsidiary of selling faulty knee replacements (MedTech Dive)