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AI guides reprogramming of CRISPR PAM specificity
Two Nature Biotechnology reports describe computationally guided routes to alter protospacer‑adjacent motif (PAM) recognition of CRISPR–Cas enzymes. One team developed Protein2PAM, a protein...
AAV-delivered suppressor tRNA enables disease‑agnostic in vivo approach
A Nature Biotechnology paper reported an AAV‑delivered suppressor tRNA engineered to read through UGA stop codons in vivo, offering a disease‑agnostic strategy for nonsense‑mutation conditions....
Natera files PMA for Signatera MRD assay in bladder cancer
Natera submitted a premarket approval (PMA) application to the U.S. FDA for its Signatera CDx circulating tumor DNA assay as a companion diagnostic to guide adjuvant atezolizumab (Tecentriq) in...
PacBio sells short‑read assets to Illumina for $48.1 million
Pacific Biosciences sold select short‑read sequencing intellectual property and assets (including technology from its Omniome/ Apton acquisition) to Illumina for approximately $48.1 million....
FDA opens PreCheck pilot to accelerate U.S. drug manufacturing builds
The U.S. Food and Drug Administration launched the PreCheck pilot program accepting applications from biopharma firms aiming to relocate or build prescription drug manufacturing capacity in the...
Sanofi’s venglustat posts split Phase 3 results — Gaucher success, Fabry failure
Sanofi disclosed mixed Phase 3 readouts for its glucosylceramide synthase inhibitor venglustat: the compound met primary and multiple secondary endpoints in a Gaucher disease trial but failed to...
Genentech licenses Sanegene RNAi program: $200M upfront, $1.7B upside
Genentech and SanegeneBio struck a global licensing deal that gives Genentech rights to an RNAi program while SanegeneBio retains early development responsibilities. Genentech paid $200 million...
Novo’s CagriSema edges semaglutide – Phase 3 diabetes readout
Novo Nordisk reported Phase 3 data showing its combination GLP‑1/amylin candidate, CagriSema, reduced blood glucose and weight more than semaglutide (Wegovy) in a type 2 diabetes population. The...
Avidity schedules spin-off record date: RNA therapeutics unit on track
Avidity Biosciences announced an expected record date for a planned spin‑off, advancing its strategy to separate a business unit focused on RNA therapeutics called Antibody Oligonucleotide...
FDA opens PreCheck submissions: push to speed US drug factory builds
The U.S. Food and Drug Administration opened submissions for its PreCheck pilot program, inviting drugmakers to participate in a pathway designed to accelerate domestic prescription drug...
EMA’s CHMP backs six new products in January
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new products during January’s review cycle, including a conditional marketing authorization on...
Daratumumab shows efficacy signals in Phase 2 lupus trial
A single‑arm Phase 2 trial reported daratumumab, an anti‑CD38 monoclonal antibody, produced promising clinical and mechanistic signals in systemic lupus erythematosus (SLE), per a Nature...
AI multiomics model improves personalized cardiovascular risk prediction
A study in Nature Communications led by Luo, Zhang, and Yang demonstrated that AI‑driven integration of multiomics datasets substantially enhanced individualized cardiovascular disease (CVD) risk...
Johns Hopkins blood test detects early cancers via epigenetic instability
Researchers at Johns Hopkins Kimmel Cancer Center unveiled a liquid‑biopsy approach that measures epigenetic variability—random fluctuations in DNA methylation patterns—to detect early‑stage...
AAV‑delivered UGA suppressor tRNA enables disease‑agnostic in vivo therapy
A Nature Biotechnology report described engineering an AAV‑deliverable suppressor tRNA that reads through UGA stop codons in vivo, presenting a potentially disease‑agnostic strategy for treating...
Protein language models reprogram CRISPR PAMs: broader editing access
Two Nature Biotechnology papers reported computational and experimental platforms that use protein language models to predict and reprogram protospacer adjacent motif (PAM) specificity of...
Genentech licenses SanegeneBio RNAi program: $200M upfront, up to $1.5B
Genentech struck an exclusive global license with SanegeneBio to develop and commercialize an undisclosed RNA interference (RNAi) program, paying $200 million up front and up to $1.5 billion in...
Novo’s CagriSema edges out semaglutide in phase 3 diabetes readouts
Novo Nordisk reported Phase 3 data showing its combo GLP‑1/amylin candidate CagriSema reduced blood glucose and body weight more than semaglutide (Wegovy) in a large type 2 diabetes trial. In...
Natera files Signatera MRD CDx to FDA for bladder cancer approval
Natera submitted a premarket approval (PMA) application to the FDA for Signatera CDx as a companion diagnostic to guide adjuvant atezolizumab (Tecentriq) in muscle‑invasive bladder cancer. The...
Hopkins unveils blood test for early cancers using epigenetic instability
Researchers at Johns Hopkins Kimmel Cancer Center introduced a liquid‑biopsy approach that detects early‑stage cancers by measuring epigenetic instability—random fluctuations in DNA...