Recon: AstraZeneca to buy Amolyt for $1.05B; BIO cuts ties with WuXi to quell US security concerns

• Medicare couldn’t cover Wegovy for weight loss. But now that it’s also a heart drug, the door is open (STAT)
• Is CAR-T safe for early-stage patients? (STAT)
• BIO severs ties with WuXi in the face of U.S. government concerns over China (STAT)
• Good health care price transparency rules are at risk if Congress doesn’t act (STAT)
• US FDA approves expanded use of Mirum's liver disease drug (Reuters)
• EPA final rule limits EtO emissions for medical device sterilizers (MedTech Dive)

• Vertex hits speed bump in getting CRISPR sickle cell therapy covered in U.K. (STAT)
• Pfizer-backed UK biotech raises £25M to advance mitophagy pipeline (Endpoints)
• Israel's Gynica starts clinical trial for endometriosis cure (Reuters)
• Shares in Spanish drugmaker Grifols tumble on Fitch, S&P downgrades (Reuters)
• Unfair Bias In Device Design: UK MHRA And Government Promise Action (MedTech Insight)
• New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate (MedTech Insight)
• European Parliament Adopts AI Act, But Success Hangs On The AI Office (MedTech Insight)
• 40% Plus Growth In Notified Body Certificates Issued Under EU Medtech Regulations (MedTech Insight)
• Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules (MedTech Insight)

• AstraZeneca picks up rare disease-focused Amolyt Pharma in $1 billion deal (STAT)
• Small studies offer hope CAR-T can fight an aggressive brain cancer (STAT)
• Argenx readies another blockbuster opportunity with its antibody drug (STAT)
• An API producer’s $250M expansion; Noramco launches US API supply; A packaging company’s 47% sales jump (Endpoints)
• Female investors track progress, call for more women on boards and in leadership roles (Endpoints)
• OcuTerra’s diabetic retinopathy drug fails PhII; Better Therapeutics to shut down (Endpoints)
• Coherus' new focus on oncology leads to restructuring, 30% layoffs (Endpoints)
• Lilly partners with Amazon to deliver Zepbound and other drugs (Reuters)

• US hospitals predict uptick in procedures as staffing pressures ease (MedTech Dive)
• Exactech hit with warning letter over implant packaging (MedTech Dive)
• Mass General Brigham works with FDA to create brain-computer interface group (MedTech Dive)
• FDA seeks feedback on expansion of premarket cybersecurity guidance (MedTech Dive)
• AI to expand medtech portfolios, revenue streams: Moody’s (MedTech Dive)
• As A Young Woman Marissa Fayer ‘Fell’ Into Medtech. Now, As An Industry Leader, She’s Focused On Leveling The Field (MedTech Insight)
• Healthtech Responds To Providers’ Productivity, Workflow And Sustainability Concerns (MedTech Insight)

• Prescription for resilience: Health care needs financial sector-inspired regulation (STAT)
• Q&A: Amid AI frenzy in medicine, a federal regulator’s quest to create safeguards (STAT)
• The Change Healthcare hack could be a catalyst for real healthcare cybersecurity improvement (Endpoints)
• Sex-Based Diversity In Clinical Trials Can And Will Improve – An IWD Perspective (MedTech Insight)
• Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3 . . . and PART 3½) (FDA Law Blog)