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Single-shot HIV vaccine shows neutralization in primates — Wistar reports breakthrough
The Wistar Institute published preclinical data showing a single-immunization vaccine candidate elicited neutralizing antibodies against HIV in nonhuman primates. The Nature Immunology study...
Diagnostics push: MRD companion seeks FDA OK while epigenetic liquid biopsy advances
Natera submitted its Signatera MRD companion diagnostic (Signatera CDx) to the FDA for premarket approval as a tool to guide adjuvant Tecentriq in muscle‑invasive bladder cancer, citing Phase III...
Sequencing sector consolidates — PacBio exits short-read, MGI scoops BGI units
Pacific Biosciences sold its short‑read sequencing assets to Illumina for $48.1 million, signaling continued strategic focus on long‑read platforms and a shift in market positioning. PacBio said...
GSK walks from RNA-editing pact — Wave reclaims lead on AATD program
GlaxoSmithKline returned rights to Wave Life Sciences’ lead RNA editing candidate for alpha‑1 antitrypsin deficiency (WVE‑006), leaving Wave to proceed independently and pursue accelerated...
Genentech licenses Sanegene RNAi: $200 million upfront
Genentech (Roche unit) struck a licensing deal with SanegeneBio that gives Genentech global rights to an undisclosed RNAi program and delivers SanegeneBio $200 million upfront. Under the...
Novo’s CagriSema tops semaglutide in Phase 3 diabetes readout
Novo Nordisk reported Phase 3 results showing its combination candidate CagriSema (semaglutide + cagrilintide) reduced blood sugar and produced greater weight loss than semaglutide in patients...
Paclitaxel shifts tumor immunity: TREM2+ macrophages rise
Researchers reported that paclitaxel chemotherapy expands a population of TREM2+ macrophages in the tumor microenvironment, a change linked to impaired antitumor immunity and reduced therapeutic...
Daratumumab shows activity in phase 2 lupus trial
A single‑arm Phase 2 study published in Nature Communications evaluated daratumumab, an anti‑CD38 antibody, in systemic lupus erythematosus (SLE) patients and reported clinical responses alongside...
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...