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AI builds bacteriophages from scratch: new era — and new risks
Researchers demonstrated AI models capable of designing complete bacteriophage genomes de novo, producing synthetic phages that infect targeted bacteria. The studies position generative models as...
Dextran nanoparticles ramp CAR‑T manufacture: scalable platform reported
Researchers reported a dextran‑based nanoparticle system that enhances CAR‑T cell production by improving transduction efficiency and cell expansion during manufacturing. The platform aims to...
FDA turmoil overshadows 2025 approvals: agency in transition
Nature Biotechnology reviewed 2025 regulatory activity and concluded that leadership changes, staffing cuts and a cascade of new policies left the FDA in a state of transition, complicating the...
Boston Scientific to buy Penumbra for $14.5 billion — broadens cardiovascular reach
Boston Scientific agreed to acquire Penumbra in a $14.5 billion cash-and-stock deal that gives the med-tech giant access to Penumbra’s mechanical thrombectomy and neurovascular portfolio. Under...
AstraZeneca pays up to $630M to own CAR‑T rights in China — full global control secured
AstraZeneca agreed to pay up to $630 million in upfront and milestone payments to acquire the remaining China rights to C-CAR031 from AbelZeta Pharma, securing full global ownership of the...
D3 Bio wins FDA IND for KRAS G12D inhibitor — first‑in‑human trial cleared
D3 Bio announced FDA IND clearance for D3S‑003, a small‑molecule KRAS G12D inhibitor, enabling a first‑in‑human phase I study in patients with advanced solid tumors harboring KRAS G12D mutations....
Engineered bacteria act as adhesive, on‑demand drug factories for IBD — Nature report
Researchers published a Nature Biotechnology study describing engineered nonpathogenic Escherichia coli programmed with a blood‑inducible circuit to detect gastrointestinal bleeding and secrete a...
Engineered UGA suppressor tRNA broadens AAV delivery options — Nature Biotechnology
A team reported in Nature Biotechnology the design of an engineered UGA suppressor tRNA gene intended to extend the scope of AAV‑delivered therapeutics by enabling suppression of UGA stop codons...
First circRNA‑encoded protein therapy enters liver‑fibrosis conversation — Shanghai teams
Researchers from the Shanghai Institute of Nutrition and Health and Guangming Advanced Research Institute described a circular RNA (circRNA) encoding human relaxin‑2 (cRLN2) as a...
AI‑designed bacteriophages built from scratch — capability raises biosecurity questions
Researchers demonstrated AI systems capable of designing complete bacteriophage genomes de novo, opening a path toward rapid, in silico creation of therapeutic phages. The work highlights...
Nanosystem delivers continuous TIMP‑1 therapy for idiopathic pulmonary fibrosis — Nature Communications
A multidisciplinary team published a Nature Communications study describing a nanosystem engineered for continuous, spatiotemporal delivery of therapeutics that target TIMP‑1 to treat idiopathic...
Real‑time metabolic monitoring enters cell & gene therapy manufacturing workflows
Industry reports highlight growing adoption of real‑time metabolic monitoring technologies in cell and gene therapy (CGT) manufacturing to improve process control and product consistency. PHCNA’s...
Nature Biotechnology: FDA leadership turmoil shadows 2025 approvals — agency shifts noted
Nature Biotechnology reported leadership changes, staff cuts and policy shifts at the US Food and Drug Administration that shadowed 2025 drug approvals, a year marked by fewer first‑in‑class...
Boston Scientific expands vascular reach: buys Penumbra for $14.5bn
Boston Scientific announced a $14.5 billion cash-and-stock acquisition of Penumbra, aiming to broaden its cardiovascular and neurovascular device portfolio. Under the terms, Penumbra shareholders...
AstraZeneca snaps up China rights to armored CAR‑T – $630M pact
AstraZeneca agreed to pay up to $630 million to acquire the remaining China rights to C‑CAR031, an armored GPC3‑targeting CAR‑T developed with AbelZeta Pharma. The deal gives AstraZeneca full...
FDA clears IND for D3 Bio’s KRAS G12D inhibitor: human trials start
D3 Bio received FDA IND clearance for D3S‑003, a KRAS G12D inhibitor, enabling a first‑in‑human Phase I study in patients with advanced solid tumors harboring KRAS G12D mutations. The clearance...
Engineered bacteria act as therapeutic glue... heal IBD in mice
Researchers published dual reports detailing an engineered nonpathogenic Escherichia coli system that senses gastrointestinal bleeding and secretes both a barnacle‑inspired adhesive (CP43K) and a...
UGA‑suppressor tRNA widens AAV delivery potential – platform advance
A Nature Biotechnology report described an engineered UGA suppressor tRNA gene designed to extend therapeutic reach for adeno‑associated virus (AAV) delivery across disease contexts. The...
AI designs phages and Golden Gate accelerates synthetic phage engineering
Two complementary advances surfaced: researchers reported AI systems capable of designing complete bacteriophage genomes from scratch, and separate teams described a Golden Gate‑based fully...
FDA turmoil shadows 2025 approvals – agency faces staffing and policy shifts
Nature Biotechnology reviewed 2025 and documented leadership turnover, staff reductions, and policy changes at the FDA that complicated the agency’s review and approval operations. The piece...