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Latest Biotech News

FDA approves first therapy for TK2 deficiency: Kygevvi clears the mark

November 06, 2025

The U.S. Food and Drug Administration approved UCB’s KYGEVVI (doxecitine and doxribtimine), the first treatment for thymidine kinase 2 deficiency (TK2d), an ultra‑rare mitochondrial disease....

Atomically accurate antibodies: RFdiffusion delivers de novo binders

November 06, 2025

Researchers published a Nature paper demonstrating RFdiffusion, an AI‑driven protein design method, can generate de novo single‑domain antibodies (VHHs) that bind user‑specified epitopes with...

Ginkgo lands BARDA pact to scale mAb manufacturing for filoviruses

November 06, 2025

Ginkgo Bioworks secured a project agreement under BARDA’s BioMaP‑Consortium worth up to $22.2 million to develop scalable, cost‑reducing approaches for monoclonal antibody manufacturing aimed at...

Hepta raises $6.7M to commercialize cfDNA epigenetic liquid biopsy for MASH

November 06, 2025

Hepta Bio closed a $6.7 million seed round led by Felicis Ventures and Illumina Ventures to advance an AI‑based epigenetic liquid biopsy that analyzes differential methylation of cell‑free DNA to...

PIM3 blockade restores CAR‑T in hypoxia — manufacturing scale still a bottleneck

November 06, 2025

Preclinical work showed inhibiting PIM3 kinase reverses hypoxia‑induced CAR‑T dysfunction, improving T cell persistence and antitumor activity in solid tumor models. The study identifies PIM3 as a...

Ferroptosis vulnerabilities mapped: FSP1 and oxygen shape targets in lung and melanoma

November 06, 2025

Two independent studies exposed ferroptosis suppression as a therapeutic vulnerability. In lung adenocarcinoma, targeting FSP1 induced ferroptotic cell death across genetically diverse tumors and...

China to lift Illumina sequencer import ban: market reopens Nov. 10

November 06, 2025

China’s Ministry of Commerce announced it will lift the import restrictions on Illumina DNA sequencers effective Nov. 10, reversing a ban imposed earlier this year. The move restores a key...

Novo ups Metsera bid to $10 billion — takeover fight intensifies

November 06, 2025

Novo Nordisk raised its offer for obesity drug developer Metsera to as much as $10 billion, escalating a bidding war with Pfizer and pushing Metsera’s board to declare Novo’s proposal superior....

FDA spurns Biohaven ataxia filing — company readies deep cuts

November 06, 2025

The U.S. Food and Drug Administration issued a complete response letter rejecting Biohaven’s NDA for troriluzole to treat spinocerebellar ataxia, citing problems with reliance on externally...

FDA approves Kygevvi: first treatment for TK2 deficiency

November 06, 2025

The FDA approved UCB’s KYGEVVI (doxecitine and doxribtimine), the first therapy for thymidine kinase 2 deficiency (TK2d), an ultra-rare mitochondrial disease. Approval was supported by a Phase II...

AI designs atom-precise antibodies — Nature validates RFdiffusion

November 06, 2025

Researchers published a Nature paper demonstrating RFdiffusion-powered de novo design of single-domain antibodies (VHHs) that bind user-specified epitopes with atomic accuracy; several designs...

Ginkgo wins BARDA contract to scale monoclonal antibody manufacturing

November 06, 2025

Ginkgo Bioworks was awarded a project agreement through BARDA’s BioMaP Consortium worth up to $22.2 million to develop cost-reducing approaches for domestic monoclonal antibody manufacturing...

Hepta raises $6.7M to commercialize cfDNA epigenetic liquid biopsy for MASH

November 06, 2025

Hepta Bio closed $6.7 million in seed financing led by Felicis Ventures and Illumina Ventures to advance an AI-driven epigenetic analysis of cell-free DNA aiming to detect chronic diseases such as...

China reopens sequencing market — Illumina returns as PacBio gains Chinese approvals

November 06, 2025

China said it will lift import restrictions on Illumina sequencers on Nov. 10, reopening a major market after months of trade frictions. Separately, Berry Genomics secured NMPA Class III approval...

Labs go autonomous: self-driving materials lab and AI scientist debut

November 06, 2025

Researchers at the University of Chicago’s Pritzker School developed an autonomous laboratory that can independently produce thin metal films, marrying robotics and AI to accelerate materials...

FSP1 and ferroptosis vulnerabilities: new targets in lung and melanoma

November 06, 2025

A Nature study identified FSP1 as an essential in vivo survival factor for lung adenocarcinoma, showing that inhibiting FSP1 induces ferroptosis across genetically diverse tumors and exposes a...

Scaling cell therapies: automation, CDMOs and tissue-targeting delivery mapped

November 06, 2025

Lonza and industry leaders argue that automation and global manufacturing networks are essential to scale CAR T and CAR Treg therapies beyond current bottlenecks, emphasizing early process...

FTC flags Novo’s Metsera offer — deal structure under scrutiny

November 06, 2025

The Federal Trade Commission told Novo Nordisk and Metsera it has concerns about the structure of Novo’s takeover proposal and whether it sidesteps required premerger review under the...

AI designs antibodies: RFdiffusion achieves atom-level binding

November 06, 2025

Researchers published Nature results showing RFdiffusion — an AI protein design model — can generate de novo single‑domain antibodies with atomic precision and confirmed binding poses by cryo‑EM....

FDA approves first treatment for TK2 deficiency — UCB’s Kygevvi cleared

November 06, 2025

The U.S. Food and Drug Administration approved UCB’s KYGEVVI (doxecitine and doxribtimine), the first therapy for thymidine kinase 2 deficiency (TK2d), an ultra‑rare mitochondrial disorder....