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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...
Xenon’s Kv7 opener delivers — Phase III clears primary endpoint
Xenon Pharmaceuticals reported that azetukalner, a Kv7 potassium channel opener, met its primary endpoint in the Phase III X‑TOLE2 study for focal onset seizures with a large, placebo‑adjusted...
Salspera files $91M IPO to fund phase 3 of salmonella‑based immunotherapy
Salspera disclosed plans for a $91 million initial public offering to bankroll Phase III trials of its lead live‑biotherapeutic candidate, saltikva, an engineered Salmonella strain expressing...
Atrium Therapeutics spins out with $270M to target genetic cardiomyopathies
Atrium Therapeutics launched as a spinout carrying Avidity Biosciences’ preclinical precision‑cardiology programs and closed with approximately $270 million in cash. The company’s two lead...
FDA clears Qiagen GI panels for QiaStat‑Dx Rise — labs gain throughput
The U.S. Food and Drug Administration cleared Qiagen’s QiaStat‑Dx Gastrointestinal Panels for the QiaStat‑Dx Rise automated, high‑throughput molecular testing platform. Laboratories can now run...
CMS proposes CRC coverage from age 45 — tougher test performance rules
The Centers for Medicare & Medicaid Services proposed revisions to the National Coverage Determination for non‑invasive colorectal cancer (CRC) screening tests, lowering covered ages to 45–85 and...
Quantifying endosomal escape: two Nature Biotechnology papers guide LNP design
Two back‑to‑back Nature Biotechnology papers provide in vivo tools to quantify endosomal escape of nucleic acid payloads and evaluate lipid nanoparticle (LNP) chemistries for liver delivery. One...
Neuland expands peptide capacity — Module One to begin commercial runs this summer
Contract development and manufacturing organization Neuland Laboratories said its new commercial peptide facility at Bonthapally will begin operations in summer, with Module One providing...
Ipsen withdraws Tazverik after safety signals — trials halted
Ipsen voluntarily withdrew Tazverik (tazemetostat) from the market and suspended ongoing clinical studies after an independent monitoring committee identified secondary hematologic malignancies in...
Vertex races to FDA: BLA filed after Phase III win
Vertex Pharmaceuticals reported pivotal late-stage success for povetacicept and has filed a Biologics License Application (BLA) targeting accelerated approval for immunoglobulin A nephropathy...
Xenon’s Kv7 drug shocks epilepsy field — Phase III clears primary goal
Xenon Pharmaceuticals reported that azetukalner, a Kv7 potassium channel opener, met the primary endpoint in the Phase III X‑TOLE2 study for focal onset seizures and will pursue an NDA filing...