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Crossing key delivery barriers: BioArctic and Lilly join BrainTransporter with a new program
BioArctic announced it has signed an $800 million research and collaboration agreement with Eli Lilly aimed at improving brain delivery. The deal combines BioArctic’s BrainTransporter technology...
Big pharma acquisition: AbbVie buys Apogee Therapeutics in a $10.9B immunology move
AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion, adding long-acting immunology assets to bolster its inflammatory disease portfolio. Apogee’s lead program, zumilokibart...
China regulatory milestone: first CAR T approval for solid tumors
China’s National Medical Products Administration approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid...
US clinical development speed: HHS/ FDA move to streamline early trials
The U.S. Department of Health and Human Services unveiled a plan to speed up early-stage drug development, including a push to reduce the timeline to first-in-human testing by 6 to 12 months. The...
Regulatory/clinical reversals: FDA agrees to accept Regenxbio resubmission path for Hunter gene therapy
Regenxbio said the FDA has reversed course on key requirements for its Hunter syndrome gene therapy (RGX-121, Navsunli) after a prior rejection. The company plans to resubmit in the third quarter...
Pivotal oncology failure: Pfizer ADC misses overall survival in Phase 3 NSCLC
Pfizer’s first pivotal readout for sigvotatug vedotin (SV, an antibody-drug conjugate acquired via Seagen) missed the overall survival primary endpoint in its Phase 3 SigVie-002 trial in advanced,...
Clinical trial disappointment for stem-cell platform: Cynata’s Cymerus fails pivotal endpoints
Cynata Therapeutics reported that neither of its pivotal Cymerus stem-cell platform trials met primary endpoints, with no statistically significant differences versus control on key efficacy...
Gene editing industry reset: Sangamo files for Chapter 11 and lines up asset sales to Lilly and Astellas
Sangamo Therapeutics filed for Chapter 11 bankruptcy protection and agreed to sell major parts of its gene editing platforms and select programs through two stalking-horse asset sale agreements....
Clinical diagnostics + guidelines: Natera Signatera MRD endorsed in NCCN bladder cancer
The National Comprehensive Cancer Network released updated bladder cancer guidelines that include Natera’s Signatera minimal residual disease (MRD) test for muscle-invasive disease after...
CAR T expands into solid tumors in China
China’s National Medical Products Administration (NMPA) has approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), the first CAR T cleared globally for solid tumors. The...
FDA shifts toward faster early development
The U.S. Department of Health and Human Services (HHS) has rolled out a department-wide plan—Operation Trailblazer—to speed up early-stage prescription drug development amid intensifying...
FDA reverses course for Regenxbio’s Hunter gene therapy
Regenxbio said the FDA will reconsider its mucopolysaccharidosis type II (Hunter syndrome) gene therapy (Navsunli / RGX-121) after the agency rejected the filing earlier this year. Regenxbio said...
Sangamo’s asset sale after bankruptcy filing
Sangamo Therapeutics has filed for Chapter 11 bankruptcy and agreed to sell multiple platforms and programs via stalking-horse bids. Eli Lilly will acquire Sangamo’s capsid delivery, zinc finger...
AbbVie buys Apogee for long-acting IL-13 therapy
AbbVie has agreed to acquire Apogee Therapeutics for $10.9 billion in cash, valuing the clinical-stage biotech at $135.11 per share. The deal centers on zumilokibart (APG777), a half-life extended...
Liquid biopsy adoption gets a boost in bladder cancer
Natera’s Signatera minimal residual disease (MRD) test has been included in updated NCCN guidelines for muscle-invasive bladder cancer. The National Comprehensive Cancer Network recommends...
AI-based chronic care gets $100M Series C
Cadence has raised $100 million in Series C funding to scale its AI-powered chronic care platform that monitors patients at home and adjusts medications in real time. The startup is valued at...
Neurodegeneration drug delivery: Lilly teams with BioArctic
Eli Lilly has signed a research and collaboration agreement with BioArctic to combine Lilly’s undisclosed drug candidate with BioArctic’s BrainTransporter technology, aiming to address the...
Soft robotics and continuous glucose monitoring without enzymes
Researchers unveiled an enzyme-independent continuous glucose monitoring approach using an acoustically readable microneedle patch (ARMPatch). The device is designed to convert ultrasound...
Definium delivers positive Phase 3 signal for single-dose LSD in MDD
Definium Therapeutics reported top-line results from a Phase 3 trial of DT-120 (lysergide, LSD) in major depressive disorder, saying the single-dose therapy significantly improved depression...
CAR-T reaches solid tumors for first time in China
China’s National Medical Products Administration (NMPA) approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid...