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AI designs antibodies with atomic precision... cryo‑EM confirms binding
A Nature paper showed RFdiffusion and allied hypermutation systems can design de novo single‑domain antibodies that bind user‑specified epitopes with atomically accurate poses, and structural work...
Hepta raises $6.7M to read cfDNA epigenome for chronic disease
Hepta Bio, a startup founded by former Illumina and Grail scientists, closed a $6.7 million seed round to develop transformer‑based AI that interprets cell‑free DNA methylation for chronic disease...
Ginkgo wins BARDA BioMaP award to scale monoclonal‑antibody production
Ginkgo Bioworks secured a Biopharmaceutical Manufacturing Preparedness Consortium contract through BARDA worth up to $22.2 million to develop cost‑reducing, scalable manufacturing approaches for...
Caplyta label expansion: J&J’s buyout validated with MDD clearance
Johnson & Johnson’s Caplyta gained FDA approval as an adjunctive treatment for major depressive disorder, expanding the label after J&J acquired the asset via its Intra‑Cellular Therapies...
PIM3 inhibition restores CAR‑T potency in hypoxic tumor niches
Researchers reported that inhibiting PIM3 kinase reverses CAR‑T cell dysfunction induced by hypoxia within solid tumor microenvironments, restoring cytotoxic activity in preclinical models. The...
AmacaThera inks $230M deal with Pacira for long‑acting local anesthetic
AmacaThera signed a licensing and collaboration agreement with Pacira BioSciences worth up to $230 million for AMT‑143, a hydrogel‑based long‑acting ropivacaine designed for extended...
Intranasal H5 vaccine primes cross‑clade immunity in Phase I trial
A Phase I study of an adjuvanted, intranasal recombinant influenza A/H5 vaccine demonstrated broad priming of immune responses across multiple H5 clades, suggesting a mucosal route could provide...
AI designs antibodies at atomic precision: RFdiffusion proves concept
Researchers have demonstrated de novo antibody design with atomic-level accuracy using RFdiffusion and an integrated hypermutation system, validating binding poses by cryo-electron microscopy. The...
FDA rejects Biohaven ataxia bid — company pivots to cuts
The U.S. Food and Drug Administration issued a complete response letter rejecting Biohaven’s New Drug Application for troriluzole in spinocerebellar ataxia, citing concerns about real‑world...
FTC flags Novo’s Metsera move — antitrust review warned
Federal Trade Commission staff warned that Novo Nordisk’s proposed deal structure for a takeover of obesity biotech Metsera may violate the Hart‑Scott‑Rodino premerger review process, raising...
Lilly’s amylin jumps to phase 3 — 20% weight‑loss signal
Eli Lilly said its experimental amylin receptor agonist eloralintide met predefined efficacy thresholds and will advance into Phase 3 testing after phase 2 results showing up to 20.1% weight loss...
Hepta raises $6.7M — AI liquid biopsy targets MASH
Hepta Bio, founded by veterans of Illumina and Grail, closed a $6.7 million seed round led by Felicis Ventures and Illumina Ventures to commercialize a transformer‑based AI that reads the...
CRISPR live imaging... captures chromatin and enhancer dynamics
Researchers unveiled CRISPR PRO‑LiveFISH, a multiplexed live‑cell imaging approach that visualizes chromatin dynamics and promoter–enhancer interactions at multiple non‑repetitive loci. Published...
China reopens to Illumina sequencers — export ban to lift Nov. 10
China’s Ministry of Commerce announced it will lift the export ban on Illumina sequencing systems on November 10, reversing restrictions imposed earlier this year and reopening a critical market...
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...