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FDA reduces primate testing: draft guidance aims to curb monkey use in mAb programs
The FDA issued draft recommendations and discussion documents indicating it will reduce or remove the routine requirement for nonhuman primate testing in some monoclonal antibody development...
Pegcetacoplan shows major clinical effect in C3 glomerulopathy — NEJM report
A Phase III trial of the complement inhibitor pegcetacoplan in C3 glomerulopathy (C3G) reported striking results in the New England Journal of Medicine: the drug produced a 68% reduction in urine...
Capricor’s Phase III win — deramiocel meets muscle and heart endpoints
Capricor reported positive topline results from its pivotal Phase III HOPE-3 trial showing deramiocel met both its primary functional endpoint and a key cardiac secondary endpoint. The company...
Pharvaris clocks Phase III win: oral HAE pill hits primary and secondary goals
Pharvaris announced that deucrictibant met primary and secondary endpoints in a pivotal Phase III study as an on‑demand oral therapy for hereditary angioedema (HAE) attacks, reporting faster...
FDA upheaval: top drug regulator to retire as acting appointments shift
Richard Pazdur, the newly installed head of the FDA’s Center for Drug Evaluation and Research, filed paperwork to retire at month‑end, compounding turnover at the agency’s senior ranks. The...
Regeneron inks $150M deal with Tessera — gene writing push for AATD
Regeneron agreed to invest in Tessera Therapeutics and to jointly develop TSRA‑196, a gene‑writing candidate designed to correct mutations that cause alpha‑1 antitrypsin deficiency (AATD)....
Illumina pivots to data services — BioInsight targets pharma and AI models
Illumina announced plans to expand beyond sequencing reagents into data‑as‑a‑service through a new BioInsight unit aimed at pharma customers. The company proposed running large, complex sequencing...
FDA proposes cutting primate tests for antibodies — new draft guidance surfaces
The FDA released draft guidance recommending ways to reduce or avoid nonhuman primate testing for certain monoclonal antibodies, signaling a regulatory shift aimed at modernizing preclinical...
Cedars‑Sinai researchers unveil TY1 — an RNA exomer that boosts DNA repair in heart injury
Cedars‑Sinai scientists published a paper in Science Translational Medicine describing TY1, a synthetic RNA‑based molecule modeled on exosomal sequences that augments TREX1 activity in macrophages...
Pegcetacoplan shows strong benefit in C3 glomerulopathy — first targeted complement therapy
A Phase III trial published in the New England Journal of Medicine showed pegcetacoplan, a C3 complement inhibitor, produced substantial reductions in proteinuria and stabilized kidney function in...
Triana raises $120M to push molecular glue degrader toward clinic
Triana Biomedicines closed a $120 million Series B round led by Pfizer Ventures and other investors to advance its CCNK molecular glue degrader program into clinical studies. The financing will...
RFdiffusion3 open‑sourced — all‑atom protein design expands to DNA binders and enzymes
The Baker lab released RFdiffusion3 as open source, an all‑atom de novo protein design model that reportedly designs binders for DNA and small molecules and generates catalytic enzymes faster than...
Capricor’s Duchenne Win — Approval Fight Reopened
Capricor Therapeutics reported positive topline results from its pivotal Phase 3 HOPE‑3 trial of deramiocel in Duchenne muscular dystrophy (DMD), meeting the study’s primary functional endpoint...
Pharvaris Pill Wins Phase 3 — FDA Filing Targeted 2026
Pharvaris reported that oral deucrictibant met all primary and secondary endpoints in a pivotal Phase 3 study as an on‑demand therapy for hereditary angioedema (HAE) attacks. The company said...
Regeneron–Tessera Deal: $150m for AATD Gene Writing
Regeneron struck a strategic collaboration with Tessera Therapeutics centered on TSRA‑196, a gene‑writing therapy designed to correct alpha‑1 antitrypsin deficiency (AATD). Regeneron will pay...
Illumina’s Data Pivot: Selling Sequencing Outputs to Pharma
Illumina unveiled BioInsight, a business unit offering end‑to‑end sequencing and curated data products to pharmaceutical partners, including large, costly perturb‑seq projects. CEO Jacob Thaysen...
FDA Turmoil: Pazdur Exit and New CDER Leadership
Top FDA drug regulator Richard Pazdur submitted paperwork to retire at month’s end, marking another abrupt leadership change at the agency’s drug center. The departure comes weeks after his...
RFdiffusion3 Goes Open Source — All‑Atom Protein Design
The Baker lab released RFdiffusion3 as open‑source software, expanding de novo protein design to create binders for DNA, small molecules and catalytic enzymes. RFdiffusion3 employs an all‑atom...
Protego Raises $130M to Advance AL Amyloidosis Drug
Protego Biopharma closed a $130 million Series B to fund a pivotal trial of PROT‑001, an oral small‑molecule kinetic stabilizer targeting immunoglobulin lambda light chains in AL amyloidosis....
eXmoor–UCL Tie‑Up to Speed Cell and Gene Therapy Translation
Contract development and manufacturing organization eXmoor Pharma signed a strategic collaboration with University College London’s Translational Research Office to accelerate academic cell and...