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Latest Biotech News

Illumina pivots: sells sequencing data to pharma — BioInsight launched

December 04, 2025

Illumina unveiled BioInsight, a new business unit offering to run large, sequencing‑intensive experiments for pharma and retain data ownership to create reusable datasets. CEO Jacob Thaysen framed...

Spatial Touchstone sets benchmarks — standards for spatial transcriptomics

December 04, 2025

A multi‑institution initiative led by St. Jude, Weill Cornell Medicine and the University of Adelaide published best practices, SOPs, quality metrics and an open reference dataset for...

Capricor turns FDA rejection into Phase III win — deramiocel clears endpoints

December 04, 2025

Capricor Therapeutics reported positive topline results from its pivotal Phase 3 HOPE-3 trial of deramiocel, the company’s cell- and exosome-based therapy for Duchenne muscular dystrophy (DMD)....

Pharvaris clocks Phase III win — oral HAE pill poised to file

December 04, 2025

Pharvaris reported that deucrictibant, its oral bradykinin B2 receptor antagonist for hereditary angioedema (HAE), met primary and secondary endpoints in a pivotal Phase 3 on-demand study. The...

FDA drug office in flux: Pazdur exits — Høeg named acting director

December 04, 2025

Top FDA drug regulator Richard Pazdur filed retirement paperwork, signaling another senior departure at the agency amid a period of rapid leadership turnover. The move comes weeks after Pazdur was...

FDA drafts changes to antibody safety testing — fewer monkey studies recommended

December 04, 2025

The FDA issued draft guidance recommending that biopharma firms can, in many cases, reduce or avoid long-duration nonhuman primate (NHP) studies during preclinical monoclonal antibody development....

AI drug discovery accelerates: RFdiffusion3 open-sourced — Terray hits BMS milestone

December 04, 2025

Two AI-driven advances landed this week: the Baker lab released RFdiffusion3 as open source, demonstrating de novo designs for DNA-binding proteins and catalytic enzymes, and Terray Therapeutics...

Triana raises $120M — molecular glue degrader heads to clinic

December 04, 2025

Triana Biomedicines closed an oversubscribed $120 million Series B to advance its molecular glue degrader pipeline toward clinical proof-of‑concept. The financing included participation from...

Two IND clears advance CNS and rare-disease programs — Latus and Vectory move to clinic

December 04, 2025

The FDA cleared INDs for two early-stage programs: Latus Bio’s LTS-101 gene therapy to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, and...

Big pharma dealmaking: Regeneron backs Tessera gene writing ($150M) — AstraZeneca buys Neurimmune asset

December 04, 2025

Regeneron struck a $150 million upfront deal with Tessera Therapeutics to develop TSRA-196, a gene-writing therapy for alpha-1 antitrypsin deficiency (AATD). Tessera will lead initial...

Diagnostics scale-up and approvals: GeninCode teams with Thermo Fisher — Devyser wins Canada clearance

December 04, 2025

GeninCode partnered with Thermo Fisher Scientific to manufacture, distribute and sell its Cardio InCode-Score, an in vitro polygenic risk score (PRS) test for cardiovascular disease, across the...

CARB‑X backs rapid infectious‑disease diagnostics — funds for ProtonDx and Scout Health

December 04, 2025

CARB‑X awarded two diagnostic developers new funding to advance point‑of‑care tests addressing pediatric respiratory infections and sexually transmitted infections. ProtonDx received $1 million to...

Deramiocel triumphs—Capricor posts positive Phase 3 topline

December 04, 2025

Capricor announced positive topline results from its pivotal Phase 3 HOPE-3 study of deramiocel in Duchenne muscular dystrophy (DMD). The company reported that the trial met its primary endpoint...

Pharvaris clocks Phase 3 win: oral HAE pill eyes 2026 filing

December 04, 2025

Pharvaris reported that deucrictibant, its oral bradykinin B2 receptor antagonist, met primary and secondary endpoints in a pivotal Phase 3 study as an on‑demand treatment for hereditary...

Protego raises $130M—preps pivotal trial for AL amyloidosis stabilizer

December 04, 2025

Protego Biopharma closed a $130 million Series B financing to advance its lead oral candidate, PROT‑001, into a pivotal trial for AL (amyloid light‑chain) amyloidosis. The company said the funds...

Regeneron-Tessera deal: $150M upfront for AATD gene‑writing program

December 04, 2025

Regeneron agreed to a strategic collaboration and equity investment in Tessera Therapeutics worth $150 million upfront to co‑develop TSRA‑196, a gene‑writing candidate for alpha‑1 antitrypsin...

Triana raises $120M—pushes molecular‑glue degrader toward clinic

December 04, 2025

Triana Biomedicines closed a $120 million Series B round, backed in part by Pfizer Ventures, to advance its lead molecular‑glue degrader into clinical development. The financing will support...

FDA clears Latus Bio IND for CLN2—designations accelerate program

December 04, 2025

Latus Bio reported FDA clearance of its investigational new drug (IND) application for LTS‑101, a gene therapy candidate targeting CNS manifestations of late‑infantile neuronal ceroid...

Vectory wins IND clearance—vectorized anti‑TDP‑43 enters ALS trials

December 04, 2025

Vectory Therapeutics secured FDA IND clearance for VTX‑002, a first‑in‑class vectorized antibody targeting TDP‑43 pathology in amyotrophic lateral sclerosis (ALS). The company said PIONEER‑ALS, a...

RFdiffusion3 open source... de novo DNA binders and advanced enzymes

December 04, 2025

Researchers from David Baker’s lab released RFdiffusion3 as open‑source software, demonstrating de novo design of proteins that bind DNA and catalyze complex chemistries. The model, described in a...