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FDA approves first TK2 deficiency therapy — KYGEVVI clears
The FDA approved UCB’s KYGEVVI (combination of pyrimidine nucleosides) as the first treatment for thymidine kinase 2 deficiency (TK2d), an ultra‑rare, often fatal mitochondrial myopathy. Approval...
Ginkgo wins BARDA contract: $22.2M push to domestic mAb manufacturing
Ginkgo Bioworks was awarded a BARDA contract worth up to $22.2 million under the BioMaP‑Consortium to develop cost‑reducing, scalable domestic manufacturing for monoclonal antibodies against...
Automating CAR‑T: Lonza lays out scale and network strategy
Lonza executives outlined a roadmap to scale CAR‑T and specialized cell therapies through automation, global manufacturing networks, and early bioprocess development. Thomas Fellner, Lonza’s head...
FTC flags Novo Nordisk deal structure: premerger review risk
The Federal Trade Commission told Novo Nordisk and Metsera in a formal letter that the structure of Novo’s proposed buyout — an upfront payment for half the company followed by later consideration...
Metsera board backs Novo’s topping bid — Pfizer fights on
Metsera’s board declared Novo Nordisk’s improved proposal a superior company proposal after a sequence of competing offers from Pfizer and Novo. Novo’s latest package increases upfront dividends...
FDA rejects Biohaven ataxia filing — company pivots to deep cuts
The FDA issued a complete response letter for Biohaven’s troriluzole New Drug Application for spinocerebellar ataxia, citing methodological issues with the company’s reliance on external control...
FDA approves first therapy for TK2 deficiency: Kygevvi clears the mark
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
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
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
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
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
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
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
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
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
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
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
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
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
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...