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Latest Biotech News

J&J expands Caplyta label — broader depression use approved after big buyout

November 07, 2025

Johnson & Johnson received FDA approval expanding the label for Caplyta (originating from Intra‑Cellular Therapies) into adjunctive treatment for major depressive disorder, a regulatory win tied...

Lilly’s amylin drug eloralintide posts strong weight‑loss — heads to phase 3

November 07, 2025

Eli Lilly reported Phase II data showing its amylin receptor agonist eloralintide achieved dose‑dependent weight losses up to ~20% at Week 48 with an apparently favorable GI tolerability profile,...

Biohub bets big on AI biology — acquires EvolutionaryScale team

November 07, 2025

Mark Zuckerberg and Priscilla Chan’s Biohub unveiled a large‑scale initiative to merge frontier AI with experimental biology and announced the integration of EvolutionaryScale’s team — the...

Intellia CRISPR trial death: regulators, partners increase scrutiny

November 07, 2025

A patient in Intellia Therapeutics’ in vivo CRISPR trial for transthyretin (ATTR) amyloidosis died after hospitalization for liver injury, prompting intensified safety reviews and an FDA...

Chan Zuckerberg Biohub buys AI lab: EvolutionaryScale team folds into Biohub

November 07, 2025

The Chan Zuckerberg Biohub announced a major expansion that folds EvolutionaryScale’s AI-for-biology team into a new, large-scale initiative pairing frontier compute with experimental biology. The...

AI designs atomically precise antibodies: RFdiffusion validated by cryo-EM

November 07, 2025

Researchers published an atomically accurate, de novo antibody design method using RFdiffusion that produced antibodies with confirmed atomic binding poses by cryo‑electron microscopy. The Nature...

Human stomach organoids reprogrammed to make insulin: in vivo proof of concept

November 07, 2025

Scientists demonstrated that human gastric organoids engineered with pancreatic reprogramming factors can produce insulin-secreting cells after transplantation into mice, lowering blood glucose...

Evommune prices $150M IPO amid market quirks

November 07, 2025

Evommune, an inflammation-focused biotech, priced a $150 million initial public offering as investors showed appetite for select clinical-stage immunology names despite a constrained IPO...

Hepta emerges with $6.7M to apply cfDNA AI to liver disease diagnostics

November 07, 2025

Hepta Bio, founded by ex‑Illumina and Grail scientists, raised $6.7 million to commercialize a transformer-based AI that decodes cell-free DNA methylation patterns to detect metabolic liver...

BIOVECTRA ties mRNA sequence design to GMP manufacturing

November 07, 2025

BIOVECTRA and Revolution Biomanufacturing announced an integrated service combining AI-driven mRNA sequence optimization with end-to-end GMP manufacturing for plasmid DNA, mRNA, LNPs and sterile...

Ginkgo wins BARDA award to speed monoclonal antibody manufacturing

November 07, 2025

Ginkgo Bioworks secured a BARDA contract — up to $22.2 million — through the BioMaP Consortium to develop cost‑reducing, rapid biomanufacturing approaches for monoclonal antibodies against...

FDA expands priority-review vouchers: Lilly, Novo among second-round winners

November 07, 2025

The FDA released a second tranche of Commissioner’s National Priority Vouchers, adding six drugs — including high-profile obesity candidates from Eli Lilly and Novo Nordisk — to a program that...

Abzena and Mabqi form integrated antibody discovery-to-development alliance

November 07, 2025

Abzena and Mabqi announced a strategic partnership to integrate Mabqi’s LiteMab antibody discovery platform with Abzena’s cell line, process development and GMP manufacturing services. The...

FTC warns Novo on Metsera bid: HSR compliance questioned

November 06, 2025

The Federal Trade Commission flagged procedural and antitrust concerns over Novo Nordisk’s bid for obesity developer Metsera, noting the deal’s structure could transfer “significant rights,...

FDA awards priority vouchers — White House seals GLP‑1 price deals

November 06, 2025

The FDA released a second batch of its National Priority (commissioner) vouchers, speeding review pathways for selected drug candidates, and the administration simultaneously announced deals with...

FDA rejects Biohaven filing — company cuts R&D and reprioritizes

November 06, 2025

The FDA issued a complete response letter for Biohaven’s troriluzole New Drug Application in spinocerebellar ataxia, rejecting the package that relied heavily on real‑world evidence and external...

Braveheart raises $185M — pushes rival hypertrophic cardiomyopathy program

November 06, 2025

Braveheart Bio closed a $185 million financing to advance a small‑molecule candidate for obstructive hypertrophic cardiomyopathy toward registration‑enabling studies, positioning it as a potential...

AI crafts atom‑level antibodies: RFdiffusion delivers de‑novo binders

November 06, 2025

Researchers demonstrated atomically precise, de novo antibody design using RFdiffusion and validated binding poses with cryo‑EM, marking a step change in computational biologics design published...

China lifts Illumina ban: sequencer imports to resume Nov. 10

November 06, 2025

China’s Ministry of Commerce said it will lift export restrictions on Illumina sequencers effective November 10, reopening a major market after months of trade curbs. Illumina confirmed the...

FDA approves UCB’s Kygevvi — first therapy for TK2 deficiency

November 06, 2025

The FDA approved UCB’s KYGEVVI (doxecitine and doxribtimine) as the first treatment for thymidine kinase 2 deficiency (TK2d), an ultra‑rare mitochondrial disorder with high pediatric mortality....