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Big‑pharma tie‑ups: Novartis, Relation and Zealand’s $2.5bn metabolic pact
Major industry collaborations continued to shape pipelines: Novartis struck a discovery and development alliance with UK biotech Relation Therapeutics that could deliver up to $1.7 billion in...
FDA vaccine frictions: internal review lands amid public pushback
Regulatory tensions intensified as an FDA staff analysis on pediatric COVID‑19 vaccine safety was circulated internally and triggered media reports that the agency is weighing unprecedented...
CRISPR momentum: in vivo successes and a field‑wide reckoning
CRISPR and gene‑editing took center stage as leaders framed 2025 as a landmark year of in vivo and personalized editing advances. In a wide‑ranging interview, Jennifer Doudna reflected on recent...
Scaling biology: 300M‑cell atlas and AI multi‑omics deals accelerate discovery
Two collaborations signaled rapid scaling of data and AI infrastructure in discovery research. Parse Biosciences and Tahoe Therapeutics agreed to generate a 300 million cell perturbation atlas to...
Rezolute collapses after pivotal miss — stock implodes
Rezolute’s Phase 3 Sunrize study of ersodetug failed to meet its primary and key secondary endpoints in congenital hyperinsulinism, prompting the company to signal program uncertainty and to plan...
Arcus–Gilead halt TIGIT program: Phase 3 failure forces R&D reset
Arcus Biosciences and Gilead reported that the Phase 3 program for the anti‑TIGIT antibody domvanalimab missed its primary endpoints, prompting an immediate pause and strategic refocus. The...
Lilly’s triple agonist smashes weight‑loss records…but tolerability clouds outlook
Eli Lilly’s triple‑agonist retatrutide delivered unprecedented weight loss in a Phase 3 study—averaging roughly 28.7% at 68 weeks—while also improving knee osteoarthritis pain. The high efficacy...
AC Immune shows biomarker wins in Parkinson’s vaccine: regulators next
AC Immune released interim biomarker results from its Phase II Vacsyn trial of the active α‑synuclein vaccine ACI‑7104, reporting changes in cerebrospinal fluid α‑synuclein and supportive...
Rezolute’s pivotal miss: ersodetug fails Phase 3, shares implode
Rezolute disclosed that its Phase 3 Sunrize study of ersodetug for congenital hyperinsulinism missed primary and key secondary endpoints, prompting management to halt investor guidance and plan...
MRD and ctDNA move toward clinic: Exact Sciences, Natera push trials and coverage
Exact Sciences presented first data showing its Oncodetect MRD test stratified distant‑recurrence risk in triple‑negative breast cancer in an NSABP B‑59 sub‑study; MRD‑positive patients after...
Regulatory shifts: FDA diagnostics reclassification and House moves to free biotech capital
The FDA proposed reclassifying some companion diagnostic nucleic‑acid tests from Class III to Class II, which would allow select tests to follow the 510(k) pathway instead of the more burdensome...
Big rounds, seed deals: China megafunds and European surfaceome startup raise capital
China’s D3 Bio and Sanegene each closed financing rounds topping $100 million, underscoring continued deep venture activity in Chinese biotech despite geopolitical headwinds. The financings...
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...