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FDA grants second wave of 'national priority' vouchers — obesity drugs among winners
The FDA released a second tranche of Commissioner’s National Priority Vouchers (CNPVs), adding six drugs to the program designed to speed review and support domestic priorities. The second round...
Metsera bidding war escalates: Novo ups bid as court refuses Pfizer block
The auction for Metsera intensified as Novo Nordisk raised its takeover bid to counter Pfizer, while a Delaware court denied Pfizer’s emergency request to block Novo’s offer. Regulators and...
Site‑specific recombinases debut — Azalea exits stealth to target in vivo gene engineering
Two developments advance in vivo gene engineering tools and companies. A Nature Biotechnology paper describes engineered recombinases capable of precise, site‑specific DNA insertion in human cells...
AI designs antibodies with atomic precision — Baker weighs in
Researchers applied RFdiffusion and a hypermutation pipeline to design de novo antibodies that bind user‑specified epitopes with atomic precision, validating designs by cryo‑EM across multiple...
Hepta raises $6.7M — cfDNA AI targets liver disease
Hepta, a startup founded by veterans from Illumina and Grail, closed $6.7 million in seed funding to commercialize transformer‑based AI that reads cell‑free DNA epigenetic signals for chronic...
BIOVECTRA, Revolution link mRNA design to GMP manufacturing
BIOVECTRA and Revolution Biomanufacturing announced a strategic partnership to offer integrated mRNA sequence optimization and end‑to‑end GMP manufacturing. Revolution brings proprietary UTR/codon...
Onchilles bags $25M to move cancer‑killing enzyme toward human trials
Onchilles Pharma closed a $25 million financing to advance a novel enzyme‑based cancer therapy modeled on a powerful immune enzyme into first‑in‑human studies. The startup’s approach engineers an...
Intellia CRISPR patient dies: MAGNITUDE investigations intensify
An elderly participant in Intellia Therapeutics’ in vivo CRISPR program died after being hospitalized with severe liver injury, prompting intensified safety reviews and an FDA clinical-hold...
Eloralintide rivals GLP‑1s — Lilly pushes amylin into Phase 3
Eli Lilly reported Phase 2 results showing its amylin receptor agonist eloralintide drove mean weight losses up to about 20% at 48 weeks and produced fewer gastrointestinal side effects than...
FDA expands voucher list — next round includes obesity players
The FDA announced a second tranche of Commissioner’s National Priority Vouchers (CNPVs), adding six more drugs that will be eligible for expedited review, and included high‑profile obesity...
FTC flags Novo’s Metsera bid — court denies Pfizer block
U.S. antitrust staff signaled concern that Novo Nordisk’s structure for acquiring obesity developer Metsera could circumvent pre‑merger Hart‑Scott‑Rodino review requirements, raising the prospect...
AI achieves atomic‑precision antibody design — structure confirms
Researchers using RFdiffusion reported de novo antibody designs that bind user‑specified epitopes with atomistic accuracy; multiple designs were validated by cryo‑EM, marking a milestone in...
Biohub hires EvolutionaryScale: Zuckerberg backs frontier AI for biology
The Chan‑Zuckerberg Biohub announced it had absorbed the EvolutionaryScale team to build a large‑scale initiative combining frontier compute, experimental biology, and AI to accelerate disease...
Ginkgo wins BARDA contract to tame mAb manufacturing costs
Ginkgo Bioworks secured a DARPA/BARDA BioMaP‑Consortium project agreement worth up to $22.2 million to develop cost‑reducing and scalable approaches for domestic monoclonal antibody manufacturing,...
MIT cell‑electronic hybrids: immune cells ferry micrometer implants
Researchers at MIT published Nature Biotechnology results demonstrating micrometer‑scale, light‑powered electronic devices chemically attached to circulating monocytes that home to inflamed brain...
BIOVECTRA pairs with Revolution to offer end‑to‑end mRNA to GMP
BIOVECTRA and Revolution Biomanufacturing announced a partnership to integrate Revolution’s sequence‑optimization platforms (UTR and codon usage engineering) with BIOVECTRA’s GMP process...
Hepta raises $6.7M to read cfDNA methylomes for chronic liver disease
Hepta Bio, founded by former Illumina, Grail and Google staffers, closed a $6.7 million seed round to commercialize transformer‑based AI that reads cell‑free DNA methylation patterns for...
Intellia trial halted: patient dies after liver injury
Intellia and partner Regeneron reported that an elderly participant dosed with nex‑z, their in vivo CRISPR therapy for ATTR amyloidosis, was hospitalized with severe liver injury and subsequently...
FDA unveils second round of national priority vouchers — obesity drugs among winners
The U.S. Food and Drug Administration announced a second tranche of Commissioner’s National Priority Vouchers (CNPVs), accelerating review pathways for six drugs that align with administration...
FTC flags Novo’s Metsera bid: pre‑merger concerns surface
Federal Trade Commission staff wrote to Novo Nordisk and Metsera raising concerns that the structure of Novo’s acquisition offer could violate the Hart‑Scott‑Rodino Act by transferring substantial...