December 16, 2025
Sanofi Licenses ADEL’s Tau-Targeting Alzheimer’s Drug for $1.04 Billion Deal Including $80M Upfront
Sanofi; ADEL; Alzheimer’s; tau-targeting; licensing deal; biotech
FDA Advances Real-World Data Use and Early-Phase Trial Reforms to Accelerate Drug Approvals
FDA; real-world data; real-world evidence; RWE; early-phase trials; drug approval; Marty Makary; Trump
J&J’s Tecvayli and Darzalex Combo Wins FDA’s Proactive National Priority Voucher for Relapsed/Refractory Multiple Myeloma
J&J; FDA; National Priority Voucher; Tecvayli; Darzalex; Multiple Myeloma; CNPV; ASH 2025
Kyverna to seek FDA engagement after positive autoimmune CAR-T data in stiff person syndrome
Kyverna; KYV-101; CAR-T; autoimmune disease; stiff person syndrome; SPS; FDA; regulatory path; cell therapy
Sanofi returns to Dren Bio for another B‑cell depletion therapy with $100M upfront
Sanofi; Dren Bio; B-cell depletion; autoimmune diseases; strategic collaboration; bispecific antibody; myeloid cell engager; immunology; $100M upfront; licensing deal
Noom Launches Proactive Health Microdose GLP-1 Program for Lower BMI Group Beyond Obesity Labels
Noom; GLP-1 microdosing; Proactive Health; BMI 21+; longevity; preventive health
FDA Approves Enhertu-Perjeta Combo for First-Line Treatment of HER2+ Metastatic Breast Cancer
Enhertu; Perjeta; FDA approval; HER2-positive; metastatic breast cancer; first-line
China’s fast, low-cost gene and cell therapy testing boom draws Western interest
China clinical trials; gene therapy; cell therapy; advanced therapy medicinal products; ATMP regulation China 2025; shortened clinical trial review; cheap clinical trials; Western biotech in China; NMPA CDE reforms; novel therapies testing
Pilatus Raises $14M for First-in-Human Study of Anti-CD36 mAb
Pilatus; funding; anti-CD36 mAb; first-in-human study; biotech
Hikma announces CEO change and Board appointment
Hikma Pharmaceuticals; CEO change; Riad Mishlawi; Said Darwazah; Khalid Nabilsi; Board appointment; executive leadership; pharmaceuticals; London; 15 December 2025