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Vitestro raises $70m — robot to scale autonomous blood draws
Vitestro closed a $70 million Series B to accelerate clinical and commercial rollout of its Aletta Autonomous Robotic Phlebotomy Device (ARPD). The Netherlands-based medical robotics developer...
FDA to consolidate adverse‑event tracking — AEMS centralizes safety reports
The U.S. Food and Drug Administration announced plans to consolidate its fragmented adverse‑event reporting systems into a single Adverse Event Monitoring System (AEMS). The agency says the...
Amino‑acid trio boosts LNP payload delivery — simple metabolic tweak raises in vivo efficacy
Researchers at Biohub reported that co‑administration of three common amino acids dramatically improves lipid nanoparticle (LNP) uptake, increasing mRNA delivery and CRISPR editing efficiency in...
Immune‑evasive DNA donors enable safer, gene‑sized insertions
Two independent teams described strategies that mitigate innate immune activation to permit kilobase‑scale DNA insertion without viral vectors. One approach—INSTALL—uses circular single‑stranded...
Nanoparticles program CAR T cells in vivo — Johns Hopkins demonstrates mRNA‑NP route
Johns Hopkins researchers reported that targeted biodegradable polymer nanoparticles carrying mRNA encoding an anti‑CD19 chimeric antigen receptor (CAR) can reprogram T cells in vivo, generating...
Regenxbio’s DMD program posts steady safety and function ahead of pivotal readout
Regenxbio presented interim Affinity trial data showing functional improvements and a clean safety profile for its DMD gene therapy candidate RGX‑202, the company said at the Muscular Dystrophy...
Optical genome mapping and structural‑variant atlas reveal variants missed by standard tests
New diagnostic and genomic mapping studies revealed clinically relevant structural variants (SVs) that standard sequencing often misses. Optical genome mapping detected additional genetic variants...
Evotec restructures — 800 jobs and four site closures in multiyear overhaul
Evotec unveiled a multi‑year restructuring that includes eliminating up to 800 positions—roughly one‑sixth of its workforce—and closing four facilities as it streamlines operations under a plan...
GSK sells linerixibat rights to Alfasigma in up‑to $690m deal as FDA decision nears
GSK agreed to transfer worldwide rights to linerixibat, an investigational IBAT inhibitor for cholestatic pruritus in primary biliary cholangitis, to Alfasigma for up to $690 million. The deal...
Pfizer shutters Ignite — pharmaco‑incubator winds down
Pfizer is winding down its Pfizer Ignite unit, a program designed to partner with and accelerate early‑stage startups, according to regulatory disclosures. The unit provided advisory services and...
FDA consolidates safety surveillance: agency rolls out AEMS
The FDA announced steps to consolidate its fragmented adverse-event reporting systems into a single platform, the Adverse Event Monitoring System (AEMS). The agency said the move will centralize...
Lilly flags impurity risk: compounded GLP‑1s under fire
Eli Lilly has publicly warned that compounded formulations of tirzepatide (the active ingredient in Zepbound/Mounjaro) that include vitamin B12 or other additives can generate a previously...
Evotec shrinks: 800 jobs cut as restructuring accelerates
Evotec unveiled a major restructuring that will eliminate up to 800 positions—about one‑sixth of its global workforce—and close four facilities as part of a cost‑cutting and refocusing program...
Amino acid boost… LNPs get a simple efficiency fix
A Biohub study published in Science Translational Medicine reports that co‑administering a three‑amino‑acid cocktail dramatically enhances lipid nanoparticle (LNP) uptake in vivo, improving mRNA...
Regenxbio’s DMD program holds as pivotal readout nears
Regenxbio reported a clean safety profile and sustained functional gains from its RGX‑202 gene therapy in Duchenne muscular dystrophy (DMD) as the program approaches a pivotal data readout....
In vivo CAR T by nanoparticles: bench method edges toward clinic
Johns Hopkins researchers published Science Advances data showing biodegradable polymeric nanoparticles can deliver mRNA encoding anti‑CD19 CARs directly to T cells in vivo, generating functional...
Optical genome mapping finds hidden variants in acute leukemia
A study in The Journal of Molecular Diagnostics showed optical genome mapping (OGM) detected additional clinically relevant structural variants in nearly 20% of acute leukemia patients when...
Pediatric cancer: pan‑cancer structural‑variant atlas released
Researchers from St. Jude Children’s Research Hospital and the National Cancer Institute published the largest pediatric cancer structural‑variant (SV) dataset to date in Cancer Cell. The...
Immune‑evasive DNA donors clear path for large gene insertions
Researchers led by teams at Massachusetts General Hospital and collaborators described a circular, immune‑evasive single‑stranded DNA donor (INSTALL) that enables safe kilobase‑scale genomic...
Targeted protein deals and RNA‑to‑heart spinout reshape dealflow
Enodia Therapeutics acquired Kezar Life Sciences’ Sec61‑based discovery assets in a deal that begins with a $1 million upfront payment and could reach up to $127 million in milestones plus...