Recon: FDA approves Gilead’s twice-yearly HIV shot; Two top FDA cell and gene therapy leaders pushed out

• HIV protection with just two shots a year: FDA approves Gilead drug (STAT)
• Gilead’s CEO on the approval of a powerful new drug to prevent HIV (STAT)
• Kennedy's new US vaccine panel to discuss measles shot for children (Reuters)
• FDA's top cell and gene therapy leaders exit agency in ongoing CBER changes (Endpoints) (STAT)
• FDA’s New Priority Voucher Pilot Program Has Landed: CNPV (FDA Law Blog)

• Lilly to appeal after UK agency opposes reimbursement for Alzheimer's drug (Reuters)
• India’s MedTech Future Hinges On Regulatory Reform And Global Alignment: MTaI’s Pavan Choudary (MedTech Insight)
• UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment (Pink Sheet)
• UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’ (Pink Sheet)

• Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout (STAT)
• Following second patient death, Duchenne muscular dystrophy families deserve answers about Elevidys (STAT)
• AbbVie's migraine drug meets main goal in head-to-head study with topiramate (Reuters)
• Bavarian Nordic's $160M FDA speedy review voucher sale shows prices keep rising amid concerns over key program (Fierce Pharma)
• BioNTech to wind down cell therapy manufacturing in Maryland, lay off 63 as it ends development of CAR-T drug in testicular cancer (Fierce Pharma)
• Hemophilia Gene Therapy Is Shown to Last for Years (Bloomberg)

• AI-powered nudges for chronic disease care need emotional intelligence (STAT)
• What David Baker’s AI biotech unicorn Xaira has been up to (STAT)
• Brain implant captures speech tone, pitch through analyzing activity (STAT)
• Grail shares jump on study results for cancer test (Endpoints)
• Dexcom recalls more than 2 million CGM receivers for lack of audible alarm (MedTech Dive)
• Medtronic training pact includes Hugo robot, cardiac ablation tech (MedTech Dive)
• Q’Apel recalls clot removal device in response to FDA warning letter (MedTech Dive)
• GE HealthCare Launches Intraoperative Ultrasound Product Series: bkActiv S (MedTech Insight)

• Tariffs disrupt ingredient markets, add uncertainty (Food Business News)
• CDC Warns of Listeria Outbreak Linked to Chicken Alfredo Meals (Bloomberg)

• Doctors lose Medicare pay bump in Senate version of tax bill (STAT)
• Curbing the overdose crisis requires professional standards, patient safety (STAT)
• What’s next for Sarepta Therapeutics with gene therapy under fire? (STAT)
• US judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list (Reuters)
• Q&A: New BIO chair to steer industry through ‘existential threats’ despite FDA receptivity (Endpoints)