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Boehringer halts inhaled CF gene therapy program — Early trials terminated
Boehringer Ingelheim discontinued development of an inhaled gene therapy for cystic fibrosis that had entered early‑stage clinical testing, the company told Endpoints News. The sponsor decided to...
Former FDA oncology chief Pazdur says he was pressured on trial cuts — Agency turmoil
Richard Pazdur, who left the FDA’s top drug review role, told The Wall Street Journal he was asked to endorse agency messaging on reducing clinical‑trial requirements, saying he was handed a press...
European VCs form ELSC to unblock life‑sciences funding — €24bn in assets behind push
Major European venture firms launched the European Life Science Coalition (ELSC) with backing from Invest Europe and members managing over €24 billion to address structural underinvestment in...
Cell‑type gene regulatory map for Alzheimer’s — SIGNET reveals causal hubs
Researchers at UC Irvine developed SIGNET, a machine‑learning framework to infer causal gene regulatory networks at cell‑type resolution and applied it to Alzheimer’s disease. The team identified...
Pazdur: I was asked to cosign FDA trial cuts
Richard Pazdur told reporters he was pressured to endorse the FDA’s decision to reduce clinical trial requirements for new drug approvals. Pazdur, the former head of the agency’s oncology unit,...
Prasad under fire — staff complaints and Moderna rift
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, is facing internal complaints and public scrutiny tied to his handling of Moderna’s influenza vaccine submission....
FDA rejects Disc’s bitopertin — questions over biomarker
The FDA declined to approve Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), citing doubts that the drug’s reduction in PPIX (a surrogate biomarker) reliably predicts clinical...
Gilead pays up for China’s Genhouse — $1.5B deal
Gilead acquired global rights to Genhouse Bio’s MAT2A-targeting cancer candidate (GH31), paying $80 million upfront and up to $1.45 billion in milestones. Genhouse has secured IND clearance in...
Fujifilm opens UK mega‑CDMO — single‑use capacity expands
Fujifilm Biotechnologies opened an expanded Teesside site in the U.K., funded by roughly £400 million, and launched what it calls the country’s largest single‑use CDMO facility. The site adds...
Europe’s VCs form coalition to fix life‑sciences funding gap
A coalition of leading European venture capital firms launched the European Life Science Coalition (ELSC) to improve capital allocation and institutional investment conditions across the...
AI targets biology: yeast DNA and antibiotic discovery
MIT researchers trained AI models to learn yeast DNA sequences and optimize protein production workflows, aiming to lower costs in vaccine and biopharmaceutical manufacturing. The model decodes...
New algorithm assembles near‑complete genomes without ultra‑long reads
Haoyu Cheng of Yale developed hifiasm (ONT), an algorithm that reconstructs near end‑to‑end human genomes using standard sequencing inputs, removing the need for ultra‑long DNA extractions that...
First cell‑type gene regulatory map for Alzheimer’s built with SIGNET
A University of California, Irvine team introduced SIGNET, a machine‑learning framework that infers cell‑type‑specific gene regulatory networks in Alzheimer’s disease and identifies causal 'hub'...
China NMPA clears Gensci‑136 for IgA nephropathy trials
Changchun Genescience Pharma received NMPA clearance to initiate clinical trials of Gensci‑136, a dual APRIL/BAFF antagonist formulated for injection to treat immunoglobulin A nephropathy (IgAN)....
AI learns yeast DNA language: boosts protein drug output
MIT chemical engineers trained an AI model to read and optimize yeast DNA sequences to improve protein production yields used in vaccines and biopharmaceutical manufacturing. The work aims to...
FDA rejects Disc’s bitopertin — agency demands clinical endpoints
The FDA issued a complete response letter rejecting Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), citing uncertainty that the drug’s surrogate biomarker (percent change in...
Gilead buys China cancer asset: $80M upfront, $1.45B in milestones
Gilead acquired global rights to Genhouse Bio’s clinic-ready MAT2A-targeting synthetic‑lethality candidate GH31, paying $80 million upfront and up to $1.45 billion in milestones plus double-digit...
Fujifilm opens UK mega‑CDMO: single‑use capacity and process hub
Fujifilm Biotechnologies inaugurated an expanded Teesside site after a roughly £400 million investment, opening what it calls the UK’s largest single‑use biopharma CDMO and a Bioprocess Innovation...
FDA turmoil: senior resignations and ethics complaints roil agency
Former CDER chief Richard Pazdur said he was pressured to endorse FDA messaging on reduced clinical‑trial requirements, telling reporters he was handed a press release and asked to "just agree to...
New algorithm builds near‑complete genomes without ultra‑long reads
Haoyu Cheng at Yale unveiled hifiasm (ONT), an algorithm that assembles near end‑to‑end human genomes using standard sequencing without needing ultra‑long DNA input. The tool reduces dependency on...