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Latest Biotech News

Optical genome mapping augments CLL workup: pilot shows broader structural variant capture

November 03, 2025

Researchers piloted optical genome mapping (OGM) alongside FISH analysis to improve diagnostic resolution in chronic lymphocytic leukemia (CLL). The study showed OGM can detect structural variants...

Plasma pTau217 test: Fujirebio aims to speed Alzheimer’s diagnosis with blood assay

November 03, 2025

Fujirebio presented data on its Lumipulse G pTau217/β‑Amyloid 1‑42 plasma ratio test, positioning the assay to shorten diagnostic timelines for Alzheimer’s disease by providing accessible...

Phage tech moves from farms to clinics: virus‑loaded patches and bird‑flu phage research advance

November 03, 2025

Researchers developed microneedle patches that deliver bacteriophages into food to kill pathogens like E. coli and Salmonella, offering a potential on‑product safety measure for ready‑to‑eat...

AI and digital twins reshape R&D: binding‑affinity models and factory simulations scale discovery

November 03, 2025

New AI models for predicting binding affinity—exemplified by Boltz‑2—and advances in digital‑twin technologies are accelerating drug discovery and industrial bioprocessing. Boltz‑2 delivers fast,...

Tumor‑activated therapy and Cas9 delivery advances push next‑gen oncology tools

November 03, 2025

Seekyo Therapeutics reported preclinical progress on a Tumor Activated Therapy (SKY01) that leverages albumin binding and tumor‑microenvironment enzyme activation to release a cytotoxic payload...

Amgen backs Milan gene-therapy play: AAVantgarde raises $141M

November 03, 2025

AAVantgarde closed a $141 million Series B led in part by Amgen Ventures to advance gene therapies for inherited retinal diseases. The Milan-based biotech will deploy capital toward programs...

Intellia paused: FDA places clinical hold after serious liver event

November 03, 2025

Intellia voluntarily paused dosing and screening in its Phase III MAGNITUDE trial and a second Phase III study after a patient experienced Grade 4 transaminase elevations and hyperbilirubinemia...

Thermo Fisher spends $9B to add clinical-trial software: Clario deal

November 03, 2025

Thermo Fisher Scientific agreed to buy Clario for about $9 billion, acquiring software that captures, manages and analyzes clinical-trial endpoint data. The acquisition complements Thermo Fisher’s...

FDA leadership in flux: CDER director George Tidmarsh placed on leave

November 03, 2025

Reports indicate George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research (CDER), has been placed on leave. Multiple outlets report the move follows internal concerns;...

Pfizer drags Metsera to court as Novo enters fray—obesity race intensifies

November 03, 2025

Pfizer sued Metsera and Novo Nordisk in Delaware’s Court of Chancery seeking to block Metsera from accepting Novo’s counteroffer and to enforce a previously agreed buyout. Pfizer had bid roughly...

Moderna’s post‑pandemic reset: contracts cut, restructuring and pressure

November 03, 2025

A detailed review of Moderna’s business shows the company grappling with slumping Covid vaccine sales, canceled government contracts and major cuts to workforce and spending plans. Washington...

Bird-flu spillovers push phage therapy and vaccine research forward

November 03, 2025

The ongoing H5N1 avian influenza outbreaks, which have killed hundreds of millions of birds and spilled into multiple mammalian species, have renewed interest in bacteriophage therapeutics and...

Orbitrap Astral Zoom: Thermo pushes proteomics throughput and depth

November 03, 2025

Thermo Fisher unveiled the Orbitrap Astral Zoom mass spectrometer, raising scan rates and adding ion pre‑accumulation to boost throughput and sensitivity for proteomics and metabolomics. The...

Boltz‑2 and physics‑based models: AI advances binding‑affinity prediction

November 03, 2025

Researchers from MIT and Recursion released Boltz‑2, an open‑source model that improved speed and accuracy for predicting binding affinities—delivering results in seconds and ranking top at CASP16...

Ultra‑broad hybrid-capture NGS flags pathogens in plasma—new diagnostic tool

November 03, 2025

A study in the Journal of Translational Medicine described an ultra‑broad hybrid-capture targeted NGS approach to detect circulating pathogen-derived cell‑free DNA in blood plasma. The method...

CDER director Tidmarsh placed on leave — FDA leadership in flux

November 03, 2025

George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research (CDER), has been placed on administrative leave, according to multiple reports. Tidmarsh leads the agency office that...

Intellia trials halted: FDA clinical hold after serious liver event

November 03, 2025

Intellia Therapeutics paused dosing and screening in two Phase III programs for its in vivo CRISPR candidate nexiguran ziclumeran (nex‑z) after a patient experienced severe liver injury; the FDA...

Thermo Fisher to buy Clario for $9B — expands eClinical footprint

November 03, 2025

Thermo Fisher Scientific agreed to acquire Clario for approximately $9 billion, adding software that collects, manages, and analyzes clinical trial endpoint data to Thermo Fisher’s biopharma...

Pfizer sues to block Metsera-Novo approach — fight over obesity assets

November 03, 2025

Pfizer filed suit in Delaware’s Court of Chancery seeking to enforce its merger agreement with Metsera and to block a rival proposal from Novo Nordisk. Pfizer alleges Metsera’s board and Novo...

Moderna’s post‑pandemic pivot falters: market value collapses

November 03, 2025

Moderna is confronting a deep business reset after Covid‑era revenues shrank and anticipated mRNA follow‑ons failed to materialize at scale. Internal and external reporting details layoffs, cost...