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Ginkgo wins BARDA award to speed monoclonal antibody manufacturing
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
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
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
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
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
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
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
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
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
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....
Ginkgo wins BARDA mandate: $22M to scale domestic mAb production
Ginkgo Bioworks secured a BARDA BioMaP contract worth up to $22.2 million to develop cost‑reducing, rapid domestic manufacturing for monoclonal antibodies against filoviruses, including Ebola and...
Hepta emerges with $6.7M seed to read cfDNA for chronic disease
Hepta Bio, founded by former Illumina and Grail staff, closed a $6.7 million seed financing to develop transformer‑based AI that decodes cfDNA methylation signals to detect chronic diseases such...
Moderna retreats on revenue: costs cut as vaccine uptake slows
Moderna reported a sharp drop in vaccine sales and signaled further cost discipline to stabilize finances, saying it expects to break even by 2028 through spending controls and pipeline...
FTC flags Metsera deal structure: premerger review eyeing compliance
Novo Nordisk raised its offer for obesity biotech Metsera as a rival bid from Pfizer intensified and U.S. antitrust officials publicly flagged the proposed transaction structure. Sources told...
FDA rebukes Biohaven’s ataxia filing — company to slash R&D
The U.S. Food and Drug Administration issued a complete response letter for Biohaven’s troriluzole in spinocerebellar ataxia, and the company immediately moved to cut annual research spending by...
Lilly advances amylin: phase 3 set after strong 48‑week results
Eli Lilly reported phase 2 data showing its amylin receptor agonist eloralintide produced dose‑dependent weight loss—up to 20.1% at Week 48—and said it will move the program into Phase 3. The...
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...