Biotech & Medicine
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In Vivo CAR-T Therapy Delivers First Human Proof-of-Concept for Autoimmune Reset, Bypassing Lab Manufacturing
MagicRNA's mRNA lipid nanoparticle therapy reprogrammed patients' own T cells inside the body, wiping out disease-driving B cells in refractory lupus patients without conventional cell manufacturing.
Japan Grants Conditional Approval to the World's First iPS Cell Therapies for Parkinson's Disease and Heart Failure
Japan's health ministry has conditionally approved two iPS cell-derived drugs, marking the first time regenerative medicines built from induced pluripotent stem cells will reach patients commercially.
First Fentanyl Vaccine Enters Human Trials in the Netherlands, Aiming to Block Overdoses Before They Start
ARMR Sciences begins Phase 1 trials of a vaccine that trains the immune system to intercept fentanyl before it reaches the brain, a preventive approach with no precedent in addiction medicine.
Roche's Amylin-Based Weight Loss Drug Delivers 10.7% Reduction in Phase 2 but Falls Short of Eli Lilly's Rival, Sending Zealand Pharma Shares Down 32%
Petrelintide met its primary endpoint with placebo-like tolerability, but a dose ceiling and a seven-point efficacy gap to Lilly's eloralintide raise questions about its standalone future.
FDA Reverses Course on UniQure's Huntington's Gene Therapy, Demanding Sham Surgery Trial in Setback That Could Add Years to Approval Timeline
The FDA rejected uniQure's Phase I/II data for AMT-130 and now demands a sham surgery-controlled Phase 3 trial, reversing its own prior guidance and sending shares down 40 percent.
Gilead's Single-Tablet HIV Regimen Matches Complex Multi-Pill Therapies in Two Phase 3 Trials, Lancet Reports
Two Phase 3 ARTISTRY trials show bictegravir/lenacapavir maintains viral suppression while replacing regimens of up to 11 daily pills with one tablet.
Base Editing Corrects a Genetic Disease for the First Time in Living Patients, Putting BEAM-302 on Track for FDA Accelerated Approval
Beam Therapeutics' BEAM-302 has achieved the first-ever in-vivo base editing correction of a disease-causing mutation in human patients, reaching therapeutic AAT levels in a Phase 1/2 trial for alpha-1 antitrypsin deficiency. A pivotal Q1 2026 data readout is now imminent.
PRIMA Retinal Implant Restores Reading Ability in 81 Percent of Blind Patients, NEJM Finds
The PRIMA wireless retinal implant restored reading ability in 81 percent of blind AMD patients in a landmark NEJM trial — the first device to restore true form vision.
Keytruda Becomes First Immunotherapy to Extend Survival in Platinum-Resistant Ovarian Cancer
FDA approves pembrolizumab for a subset of ovarian cancer patients after Phase 3 KEYNOTE-B96 trial shows the first overall survival benefit ever demonstrated by an immunotherapy in this setting.
Blood Test Can Forecast When Alzheimer's Symptoms Will Begin, Study in Nature Medicine Finds
A Washington University team showed a p-tau217 blood test can estimate Alzheimer's symptom onset within 3-4 years, potentially transforming early intervention and clinical trials.
Merck's Once-Daily Cholesterol Pill Matches Injectable Efficacy in Phase 3 Trial, Opening Path to First Oral PCSK9 Inhibitor
Enlicitide decanoate cut LDL cholesterol by 57% in 2,900+ patients in the CORALreef Lipids Phase 3 trial — matching injectable PCSK9 inhibitors in pill form, with no meaningful safety signals over 52 weeks.
UC San Diego Team Builds a CRISPR Gene Drive That Spreads Through Bacteria and Strips Away Antibiotic Resistance
A second-generation Pro-Active Genetics system spreads via bacterial conjugation to disable resistance genes on plasmids, working even inside biofilms.