Recon: FDA approves Gilead’s twice-yearly HIV shot; Two top FDA cell and gene therapy leaders pushed out
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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