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Quantifying endosomal escape: new in vivo assays point the way for liver LNPs
Two independent reports introduced in vivo methods to quantify endosomal escape — the rate‑limiting step for lipid nanoparticle (LNP) delivery — and applied the assays to optimize liver-targeted...
BioNTech founders exit — next‑gen mRNA spinout in the works
Uğur Şahin and Özlem Türeci, BioNTech’s co‑founders, announced plans to leave the company by year‑end to launch a new venture focused on next‑generation mRNA technologies. BioNTech will grant the...
Atrium Therapeutics launched with $270M — RNA delivery to the heart
A new spinout, Atrium Therapeutics, launched with approximately $270 million in cash and assets carved out from Avidity Biosciences to pursue RNA therapeutics for rare genetic cardiomyopathies....
Evotec deepens restructuring — 800 roles and multiple site closures
German drug discovery and contract services firm Evotec announced a sweeping restructuring that will cut roughly one‑sixth of its workforce—about 800 people—and close four additional sites as part...
Manufacturing scale‑up: Lonza expands gene‑therapy capacity — CSL builds $1.5B plasma plant
Two major manufacturing investments signal expanded capacity for complex biologics: Lonza agreed to expand commercial manufacturing to continue production of Genetix Biotherapeutics' ZYNTEGLO gene...
Investors double down on AI biology — Breakout $114M, Living Models $7M
Venture capital continues to fund AI‑centric biology startups: Breakout Ventures closed a $114 million Fund III to back early‑stage companies translating academic breakthroughs into scalable...
Electrical stimulation advances restore movement and sensation after SCI
Two clinical teams reported advances in electrical neuromodulation that restored motor function and somatosensory feedback in people with chronic spinal cord injury (SCI). A Brown University–led...
FDA consolidates adverse‑event tracking — single monitoring system planned
The U.S. FDA announced plans to merge multiple adverse event (AE) reporting tools into a single Adverse Event Monitoring System that will ultimately centralize reports across agency centers,...
Vertex races to FDA: BLA filing looms after Phase III win
Vertex said it will move rapidly toward U.S. regulatory filings after a Phase III Rainier trial produced strong reductions in proteinuria for povetacicept in immunoglobulin A nephropathy (IgAN)....
FDA narrows leucovorin approval — not for autism
The U.S. FDA approved leucovorin (Wellcovorin) for a specific genetic form of cerebral folate deficiency (CFD‑FOLR1) but declined to broaden the label to autism spectrum disorder. Regulators based...
BioNTech founders exit... next‑gen mRNA startup incoming
BioNTech confirmed that co‑founders Ugur Şahin and Özlem Türeci will step down by year‑end to found a new company focused on next‑generation mRNA technologies. BioNTech said it will grant the new...
In vivo assay quantifies endosomal escape: guides LNP liver delivery
Two independent Nature Biotechnology reports introduced quantitative, in vivo assays that measure endosomal escape of lipid nanoparticles (LNPs) in the liver and used those readouts to optimize...
Lilly pledges $3B to China — builds GLP‑1 manufacturing; $500M for Korea
Eli Lilly announced a major manufacturing push in East Asia, earmarking roughly $3 billion over the next decade to expand oral solid‑dose capacity in China to support the launch of its GLP‑1...
Xenon’s Kv7 comeback: Phase III X‑TOLE2 smashes seizure endpoint
Xenon Pharmaceuticals reported highly positive Phase III X‑TOLE2 data for azetukalner, a Kv7 potassium channel opener, showing a substantial placebo‑adjusted reduction in monthly focal onset...
Biomimetic ferritin engager: CAR‑T potency rises without reengineering
Researchers unveiled a ferritin‑based aggregation cell engager (FACE) that acts as a biomimetic bridge between CAR‑T cells and leukemia targets, increasing functional avidity without altering CAR...
Atrium launches with $270M — RNA delivery to the heart in sights
A new spinout, Atrium Therapeutics, emerged with approximately $270 million in funding to advance RNA therapeutics targeting rare genetic cardiomyopathies. The company acquired preclinical...
Qiagen clears GI panels for QiaStat‑Dx Rise — hour‑long syndromic testing
Qiagen won FDA clearance to run its QiaStat‑Dx Gastrointestinal Panels on the high‑throughput QiaStat‑Dx Rise platform, enabling combined respiratory and GI syndromic testing on a single automated...
CMS eyes colorectal NCD change: coverage from 45, tighter test performance
CMS proposed revisions to the National Coverage Determination for non‑invasive colorectal cancer (CRC) screening tests, extending coverage down to beneficiaries aged 45–85 and raising performance...
Vertex files BLA after Phase III win — IgAN race heats up
Vertex filed a biologics license application after late‑stage Rainier data showed substantial reduction in proteinuria for immunoglobulin A nephropathy (IgAN). The company reported a marked drop...
BioNTech founders depart: next‑gen mRNA startup on the way
BioNTech co‑founders Ugur Şahin and Özlem Türeci will leave the company by year‑end to launch a new firm focused on next‑generation mRNA therapeutics. BioNTech said it will license certain mRNA...