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NIH reshapes NIAID: 'pandemic preparedness' language removed
Internal directives at the National Institute of Allergy and Infectious Diseases (NIAID) instructed staff to remove references to 'biodefense' and 'pandemic preparedness' from public webpages,...
Gilead pays $80M upfront for Genhouse’s GH31 — $1.45B upside
Gilead Sciences struck a licensing deal with China’s Genhouse Bio to secure global rights to GH31, a MAT2A‑targeted therapy for MTAP‑deleted solid tumors, paying $80 million upfront with up to...
ArgenTag joins PacBio program: long‑read single‑cell transcriptomics goes portable
ArgenTag announced a co‑marketing partnership with PacBio, confirming compatibility of ArgenTag’s single‑cell RNA library kit with PacBio’s Kinnex RNA kits to enable long‑read, full‑length isoform...
ML‑predicted insulin resistance linked to 12 cancers: population‑scale study
Researchers led by the University of Tokyo applied a machine‑learning model (AI‑IR) to predict insulin resistance from routine clinical data across 500,000 UK Biobank participants and found...
St. Jude unveils M‑PACT: AI liquid biopsy classifies pediatric brain tumors
St. Jude Children’s Research Hospital and international collaborators introduced M‑PACT (Methylation‑based Predictive Algorithm for CNS Tumors), an AI platform that uses cerebrospinal fluid...
Compass psilocybin... Second Phase‑3 Hit Paves NDA Push
Compass Pathways reported a second positive pivotal trial for its synthetic psilocybin candidate COMP‑360, clearing a major regulatory milestone and triggering a fast‑track approval push. The...
Ocular’s Axpaxli Tops Low‑Dose Eylea – Market Reaction Tepid
Ocular Therapeutix announced that Axpaxli (OTX‑TKI) achieved statistical superiority to a low‑dose regimen of Regeneron/Bayer’s Eylea in the Sol‑1 Phase‑3 superiority trial for wet age‑related...
Danaher to buy Masimo: $9.9 billion deal announced
Danaher Corporation agreed to acquire Masimo for $9.9 billion in cash, offering $180 per share and a roughly 38% premium to Masimo’s last close, the companies disclosed. The transaction will fold...
Nektar’s rezpeg... Mid‑stage win sparks comeback and $460M raise
Nektar Therapeutics released positive maintenance data from the 52‑week Phase IIb REZOLVE‑AD study of rezpegaldesleukin (rezpeg) in moderate‑to‑severe atopic dermatitis. The drug hit high rates of...
FDA rejects Disc’s bitopertin—voucher program faces first failure
The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin in erythropoietic protoporphyria (EPP), questioning whether the surrogate biomarker (PPIX reduction) reasonably predicts...
Lex Diagnostics gets FDA greenlight for Velo PCR: 510(k) and CLIA waiver
Lex Diagnostics secured 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular diagnostic system and a multiplex respiratory cartridge for influenza A/B and SARS‑CoV‑2. The system...
Zelluna hires Medpace to run Phase I of off‑the‑shelf TCR‑NK therapy
Norwegian cell‑therapy developer Zelluna selected Medpace as CRO for its first‑in‑human Phase I trial of ZI‑MA4‑1 (ZIMA‑101), an allogeneic TCR‑NK product targeting MAGE‑A4 across solid tumors....
ArgenTag and PacBio partner to enable long‑read single‑cell isoform sequencing
ArgenTag announced a co‑marketing and compatibility agreement with Pacific Biosciences, confirming ArgenTag’s single‑cell long‑read RNA library kit works with PacBio’s Kinnex RNA kits and HiFi...
Systematic molecular‑glue discovery... New high‑throughput ligand diversification method
Two complementary reports described scalable approaches to discover molecular glues—small molecules that induce proximity between a target protein and ubiquitin ligases to trigger degradation. One...
Compass nails second Phase 3: psilocybin meets endpoint in treatment‑resistant depression
Compass Pathways reported a second positive pivotal trial for its synthetic psilocybin candidate COMP‑360 and is advancing toward regulatory filing. The company said both Phase 3 studies met their...
Ocular’s Axpaxli shows superiority at week 36 – trial beats low‑dose Eylea
Ocular Therapeutix reported that its intravitreal hydrogel Axpaxli (OTX‑TKI) met the superiority primary endpoint versus a low‑dose aflibercept (Eylea) in the Sol‑1 Phase 3 trial for wet...
Federal judge narrows Moderna’s defenses in long mRNA patent fight with Arbutus
A federal judge rejected portions of Moderna’s defenses in its protracted patent dispute with Arbutus, advancing Arbutus’s claims in litigation tied to mRNA technology. Court rulings limited...
Velo cleared in US; Ella platform wins EU mark — point‑of‑care and benchtop diagnostics advance
Two regulatory moves broaden the toolkit for decentralized testing and translational research. Lex Diagnostics secured FDA 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular...
FDA rejects Disc Medicine’s bitopertin: agency questions surrogate endpoint
The FDA declined approval for Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), marking a setback for a drug that had previously been selected for an accelerated regulatory...
NIAID told to drop 'pandemic preparedness' language — institute refocuses mission
Staff at the National Institute of Allergy and Infectious Diseases were directed to remove references to 'biodefense' and 'pandemic preparedness' from web pages as NIAID undergoes a strategic...