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Diagnostics and CRO M&A: Natera expands with Foresight; Paradigm buys Flatiron research arm
Natera agreed to acquire Foresight Diagnostics to integrate its PhaseED‑seq phased‑variant enrichment tech, aiming to boost Signatera’s sensitivity and to expand into hematologic MRD testing....
CAR‑T pipeline turbulence: Umoja delays in vivo readout; USC posts safer next‑gen CAR‑T preclinical data
Umoja Biopharma announced a delay to its first clinical readout for an in vivo CAR‑T therapy conducted in China, shifting expectations for early human data from a well‑funded in vivo CAR‑T...
Gene editing and policy: metagenomic editing in vivo and calls for a rare‑disease approval pathway
Researchers published a metagenomic‑editing advance demonstrating integration of large DNA constructs into gut bacteria in vivo, a technical leap for microbiome engineering with potential...
Lilly’s triple agonist sets new efficacy bar — 28.7% weight loss
Eli Lilly reported Phase 3 results showing its triple-agonist retatrutide delivered unprecedented weight loss in patients with obesity, with the high-dose cohort averaging 28.7% body-weight...
Rezolute’s pivotal miss forces program rethink: Phase III fails endpoints
Rezolute announced that Sunrize, the Phase 3 study of its sole therapeutic candidate ersodetug for congenital hyperinsulinism, failed to meet primary and key secondary endpoints. The company...
AC Immune’s Parkinson’s vaccine posts biomarker wins — regulator talks planned
AC Immune disclosed interim biomarker data from its Phase 2 Vacsyn trial of active anti–α‑synuclein immunotherapy, reporting directional changes in a coherent biomarker suite including CSF...
Umoja delays first in vivo CAR‑T readout — timelines slip
Umoja Biopharma said it is delaying the first clinical readout from its China‑based in vivo CAR‑T trial. The company did not provide a new disclosure date but acknowledged the postponement will...
Illumina backs MyOme — trial to test WGS plus AI for population prevention
MyOme announced an investment from Illumina and plans to launch a prospective clinical trial, MyOme’s Proactive Health (MPH), combining whole‑genome sequencing on Illumina’s NovaSeq X with AI...
Natera buys Foresight to beef up MRD sensitivity — Signatera gains phased‑variant tech
Natera agreed to acquire Foresight Diagnostics for $275 million plus up to $175 million in earnouts to integrate Foresight’s PhaseED‑seq phased‑variant technology into Natera’s Signatera...
Metagenomic editing inserts big DNA payloads into gut bacteria in vivo
A Nature Biotechnology paper reported a new metagenomic‑editing platform that integrates large DNA sequences into gut bacteria directly in vivo. The method enables targeted insertion of...
ARPA‑H backs AI toxicity models — $21M award to industrial‑academic consortium
Inductive Bio received an award of up to $21 million from ARPA‑H to lead DATAMAP, a consortium effort to develop next‑generation AI models for drug toxicity prediction using human‑relevant...
Paradigm buys Flatiron research unit — expands trial access with $78M Series B
Paradigm Health completed the acquisition of Flatiron Health’s clinical research business and simultaneously closed a $78 million Series B to finance expansion. The deal adds a network of academic...
FDA proposes lowering companion‑diagnostic bar — Class II pathway eyed
The U.S. Food and Drug Administration proposed a rule to reclassify certain nucleic‑acid–based companion diagnostic assays from Class III to Class II, potentially allowing those tests to use the...
Lilly’s triple agonist shatters expectations — efficacy and tolerability collide
Eli Lilly reported headline-setting Phase 3 weight-loss data for retatrutide, a triple-agonist metabolic candidate, delivering unprecedented mean weight reduction but raising tolerability...
AC Immune’s Parkinson’s vaccine: biomarker wins, clinical benefit still opaque
AC Immune announced positive interim biomarker and safety signals from its Phase II Vacsyn trial of ACI-7104.056, an active immunotherapy targeting alpha‑synuclein in early Parkinson’s disease....
Regulatory chaos: FDA staff alarm and industry confidence wobble
Multiple reports this week documented deep unease inside the FDA and across drug developers as leadership turnover and high‑profile policy moves unsettle established regulatory norms. A BioCentury...
China’s biotech cash surge: multiple $100M rounds reshape dealmaking
Venture activity in China’s life‑science sector accelerated with multiple large financings announced this week, including seven‑figure and nine‑figure rounds that signal continued appetite for...
FDA greenlights nonprofit gene therapy — Waskyra marks precedent
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome developed and sponsored by a nonprofit foundation, marking the first gene therapy authorization awarded to a non‑commercial...
CAR‑T landscape: in vivo delays meet next‑gen constructs in mice
Umoja Biopharma delayed its first clinical readout for an in‑vivo CAR‑T program, citing operational and timeline adjustments, while academic teams disclosed preclinical next‑generation CAR‑T...
AI scales biology: pathology models and 300M‑cell atlas move forward
Two high‑impact AI initiatives this week signalled advancement in computational biology infrastructure. Researchers published a multimodal foundation model tuned for whole‑slide pathology,...