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CMS covers Personalis NeXT Personal MRD test for lung cancer surveillance
The Centers for Medicare & Medicaid Services granted Medicare coverage for Personalis’ NeXT Personal molecular residual disease (MRD) test to support surveillance of stages I–III non‑small cell...
Thermo Fisher and Datavant tie trial data to real‑world records — privacy tokens enabled
Thermo Fisher Scientific’s PPD clinical research business partnered with Datavant to enable privacy‑preserving linkage of de‑identified research datasets to real‑world patient records across a...
Generate Biomedicines files IPO as Phase III dosing begins for AI‑designed antibody
Generate Biomedicines filed for an initial public offering days after initiating Phase III dosing for GB‑0895, an AI‑designed anti‑TSLP antibody for severe asthma. The company said proceeds will...
Microbiotica’s oral live biotherapeutic posts positive Phase Ib UC remission rates
Microbiotica reported positive Phase Ib data for MB‑310, an orally administered live biotherapeutic for ulcerative colitis: 12 of 19 treated patients achieved clinical remission versus 3 of 10 on...
FDA refuses to review Moderna’s mRNA flu shot: regulator flags trial design
The FDA has refused to begin formal review of Moderna’s mRNA influenza vaccine application, citing deficiencies in the pivotal trial’s control arm and trial design. The decision was signed by...
PTAB invalidates Exact Sciences patents: Geneoscopy says it clears path for ColoSense
The Patent Trial and Appeal Board issued a final written decision invalidating claims from Exact Sciences’ US Patent No. 11,970,746 after an inter partes review requested by Geneoscopy. The PTAB...
ILiAD raises $115M to push live pertussis vaccine into pivotal testing
ILiAD Biotechnologies closed an oversubscribed $115 million Series B led by RA Capital to advance BPZE1, a live attenuated intranasal pertussis vaccine, toward Phase III development. The funding...
Eczema readouts shake up immunology field — Evommune and Nektar post strong Phase II data
Two mid-stage immunology readouts delivered large market reactions: Evommune reported Dupixent‑comparable EASI reductions with EVO301 in atopic dermatitis, while Nektar said rezpegaldesleukin...
FDA issues complete response letter to Regenxbio gene therapy — regulator flags data gaps
Regenxbio received a complete response letter for RGX‑121, its AAV‑based gene therapy for mucopolysaccharidosis II (Hunter syndrome), after the agency raised concerns about the surrogate endpoint...
Capsida confirms cerebral edema in fatal trial case — investigations continue
Capsida Biotherapeutics reported an autopsy‑confirmed cause of death as cerebral edema for the patient who died after infusion in its suspended SYNRGY trial of CAP‑002, an AAV gene therapy for...
Madrigal expands MASH arsenal: $60M upfront, up to $4.4B in siRNA deal with Ribo
Madrigal Pharmaceuticals struck a major licensing and acquisition push to bolster its MASH pipeline, agreeing to license six preclinical siRNA programs from China’s Ribo Life Science and paying...
Medicare covers Personalis’ NeXT Personal MRD test for lung‑cancer surveillance
The Centers for Medicare & Medicaid Services granted coverage for Personalis’ NeXT Personal molecular residual disease assay for surveillance of stage I–III non‑small cell lung cancer. CMS based...
Thermo Fisher, Datavant partner to link clinical research with large real‑world data sets
Thermo Fisher Scientific’s PPD clinical research business announced a strategic partnership with Datavant to enable privacy‑preserving tokenization and linkage of de‑identified patient data across...
Lilly buys Orna in multimodal deal — in vivo CAR‑T and circular RNA technologies in focus
Eli Lilly agreed to acquire Orna Therapeutics to add circular RNA (oRNA) and LNP delivery capabilities aimed at enabling in vivo CAR‑T therapies, in a transaction with up to $2.4 billion in...
FDA refuses to review Moderna mRNA flu vaccine — CBER flags trial design
The FDA declined to start a review of Moderna’s experimental mRNA influenza vaccine, citing deficiencies in the trial’s control arm and overall study design in a letter signed by Vinay Prasad,...
FDA issues complete response letter to Regenxbio — Hunter syndrome approval paused
The FDA issued a complete response letter to Regenxbio for RGX‑121, a proposed gene therapy for mucopolysaccharidosis type II (Hunter syndrome), saying the submission did not adequately support...
Capsida confirms cerebral edema in AAV trial fatality — probe continues
Capsida Biotherapeutics reported that an autopsy confirmed cerebral edema as the cause of death in a patient treated in its SYNRGY AAV gene‑therapy trial for STXBP1, but the company said the...
ILiAD raises $115M Series B to launch pivotal pertussis program
ILiAD Biotechnologies closed an oversubscribed $115 million Series B led by RA Capital Management, with participation from Janus Henderson and BNP Paribas Asset Management Alts, to advance its...
Madrigal snaps up six China‑sourced siRNAs: $60M now, $4.4B possible
Madrigal Pharmaceuticals struck a series of deals with Suzhou Ribo Life Science and Ribocure Pharmaceuticals to license six preclinical siRNA programs aimed at metabolic dysfunction‑associated...
Atopic dermatitis shakeup: Evommune posts Dupixent‑competitive Phase II... Nektar shows year‑long durability
Two mid‑stage readouts shifted expectations in atopic dermatitis. Evommune reported EVO301 achieved a statistically significant placebo‑adjusted improvement in EASI scores at Week 12 that the...