Recon: US FTC sues to block Amgen’s $28B Horizon acquisition; Cook Medical lays of 500 of its global workforce

• Amgen’s $28 Billion Horizon Deal Faces Unexpected FTC Hurdle (Bloomberg) (Reuters) (Fierce)
• FDA staff support safety data for Pfizer's RSV vaccine to protect newborns (Reuters)
• Product Quality ‘Wild Card’? Sarepta’s Gene Therapy Manufacturing Process Change Means More Empty Capsids (Pink Sheet)
• FDA orders Sun to hire manufacturing consultant for troubled plant as export pause persists (Fierce)
• FDA issues CRL to small Dutch biotech's breast cancer ADC as OS figures fail to impress (Endpoints)
• FDA 483 report to IPCA Laboratories (FDA)
• The U.S. needs to pressure India to improve drug safety (STAT)
• When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot (Pink Sheet)
• Biden drug czar to summon naloxone makers to White House to discuss pricing (STAT)
• The Foundation for the National Institutes of Health Announces Selection of Eight Rare Diseases for the Bespoke Gene Therapy Consortium, Clinical Trial Portfolio (NIH Foundation)
• $97M gene therapy consortium aims to give companies and rare disease families a ‘north star’ (Endpoints)
• ‘Stunning’ change to United’s colonoscopy coverage roils physicians and patients (STAT)
• Obamacare Preventive Care Row Gets Temporary Administrative Stay (Bloomberg)

• WHO warns against bias, misinformation in using AI in healthcare (Reuters)
• WHO moves health office from Moscow to Copenhagen (MedWatch)
• Europe’s AI Act could take more than a year to adopt (MedWatch)
• EU Pharma Revision Proposes Changes To Drug Safety Reporting (Pink Sheet)
• Don’t Use Artificial Sweeteners for Weight Loss, WHO Says (Bloomberg)
• Patient Groups Want More Say In Talks On New UK Pricing Deal (Pink Sheet)

• Scribe’s CRISPR tech Prevails in new $1.5B biobucks deal with Lilly unit (Fierce)
• AstraZeneca is third member to leave PhRMA in five months (STAT) (Reuters)
• Boundless ups fundraising by Leaps and bounds, adding another $100M haul (Fierce)
• Astellas, Sony Team on Novel ADC Platform for Oncology (BioSpace)
• Gilead expands its big bet on Arcus, moving into inflammation in large new collaboration (Endpoints)
• Viking Therapeutics's NASH drug succeeds in mid-stage trial, shares jump (Reuters)
• Juno Pharmaceuticals picks up Omega Labs to expand its injectables business in Canada (Fierce)
• Still under clinical hold, Fulcrum locks in seasoned commercial leader as CEO (Endpoints)
• Flagship launches metaphor with $50M to mimic the molecular version of the owl butterfly (Fierce)
• Boundless Bio tests a cancer drug targeting once-mysterious DNA loops (STAT)

• Minute Insight: Cook Cuts 4% Of Its Global Workforce (MedTech Insight) (MedTech Dive)
• Device Industry Sees Surge in Trade Agreement, False Claims Litigation (FDANews)
• Most Class I Device Recall notices Lack Key Identification Numbers, Study Says (FDANews)
• Diabetes app developers must generate more data on clinical effectiveness, study says (MedTech Dive)
• Embecta joins Tidepool to develop insulin pump, raises Q2 growth outlook (MedTech Dive)
• General Catalyst, Andreessen Horowitz bet on large language models for health care (STAT)

• Supreme Court Declines ‘Skinny Label’ Case, But Teva To Continue Fight In District Court (Pink Sheet)
• Talc claimants look to sue J&J over alleged fraud in bankruptcy case (Endpoints)
• Plaintiffs Suing Jazz in Xyrem Antitrust Row Get Class Certified (Bloomberg)
• Natera Wins $19.4 Million Blood-Based Cancer-Test Patent Verdict (Bloomberg)
• Moderna goes after Alnylam, filing counterclaims in Spikevax patent suit (Endpoints)