Get the Daily Brief
Latest Biotech News
Oncolytic virus injection reprograms glioblastoma microenvironment — single‑dose immune effect
A collaborative team from Mass General Brigham and Dana‑Farber reported that a single intratumoral injection of a genetically engineered oncolytic virus can remold the glioblastoma tumor...
Microbiotica posts positive Phase Ib data in ulcerative colitis — oral live therapeutic shows remission
Microbiotica reported Phase Ib results for MB‑310, an orally delivered live biotherapeutic for ulcerative colitis, showing 12 of 19 treated patients reached clinical remission versus 3 of 10 on...
Thermo Fisher, Datavant tie up — encrypted tokens to link RWD across trials and registries
Thermo Fisher Scientific’s PPD clinical research business announced a strategic partnership with Datavant to enable privacy‑preserving linkage of de‑identified real‑world data (RWD) across more...
Dewpoint nominates MYC condensate modulator — small molecule targets transcriptional condensates
Dewpoint Therapeutics announced a development candidate in its MYC program — a first‑in‑class small molecule designed to modulate aberrant biomolecular condensates that organize oncogenic...
FDA refuses to review Moderna flu shot: agency cites trial design
The U.S. Food and Drug Administration has refused to begin review of Moderna’s mRNA influenza vaccine application, flagging problems with the trial’s control arm rather than safety or efficacy...
BridgeBio’s oral dwarfism drug wins Phase 3 — company eyes approval push
BridgeBio reported that its oral FGFR inhibitor infigratinib met the primary and key secondary endpoints in a pivotal Phase 3 study for achondroplasia, producing statistically significant...
Madrigal inks Ribo siRNA pact — $60M up front, $4.4B in milestones
Madrigal Pharmaceuticals struck a global licensing agreement with Suzhou Ribo Life Science and Ribocure granting Madrigal rights to six preclinical siRNA programs targeting metabolic...
QuidelOrtho waits on FDA for Lex Dx clearance — acquisition conditional
QuidelOrtho told investors that its planned acquisition of UK molecular system developer Lex Diagnostics depends on imminent FDA clearance of Lex’s point‑of‑care PCR Velo system and the agency’s...
Thermo Fisher links with Datavant: real‑world data joins clinical research
Thermo Fisher Scientific’s PPD clinical research business struck a strategic partnership with Datavant to enable privacy‑preserving linkage of de‑identified patient data across more than 350 RWD...
ILiAD raises $115M to advance intranasal pertussis vaccine into Phase III
ILiAD Biotechnologies closed an oversubscribed $115 million Series B to advance its live attenuated intranasal pertussis vaccine BPZE1 into pivotal Phase III development and human challenge...
Seres pauses lead program and trims headcount amid strategic shift
Microbiome therapeutics developer Seres Therapeutics announced a further workforce reduction and a pause in its lead program following earlier layoffs and portfolio reassessment. The company is...
AI drug‑discovery models face scrutiny — ‘cheating’ claims and model rivalries
A cluster of industry voices raised fresh concerns about robustness and transparency in AI‑driven drug discovery. Leash Bio researchers warned that some models can ‘cheat’—exploiting dataset...
Condensates take center stage — Dewpoint names MYC modulator; new discovery tools emerge
Dewpoint Therapeutics nominated a first‑in‑class small‑molecule development candidate designed to modulate aberrant MYC‑driven transcription by targeting biomolecular condensates that organize...
Precision Biosciences cleared to begin PBGENE‑DMD clinical trial
Precision Biosciences received FDA clearance of an Investigational New Drug enabling activation of a Phase I/II study (FUNCTION‑DMD) for PBGENE‑DMD, its genome‑editing candidate for ambulatory...
FDA refuses to review Moderna flu shot: agency cites trial design
The U.S. Food and Drug Administration has refused to start a review of Moderna’s mRNA influenza vaccine application, citing deficiencies in the pivotal trial’s design rather than safety or...
BridgeBio’s oral dwarfism drug wins Phase 3 – preps FDA push
BridgeBio reported that its oral FGFR inhibitor infigratinib met the primary endpoint in a Phase 3 study for achondroplasia, producing statistically significant increases in annualized height...
FDA issues complete response for Regenxbio gene therapy: data questions linger
The FDA issued a complete response letter (CRL) for Regenxbio’s RGX‑121 gene therapy for mucopolysaccharidosis II (Hunter syndrome), citing concerns about surrogate endpoints and the robustness of...
Madrigal inks $4.4B siRNA pact with Ribo: MASH pipeline expands
Madrigal Pharmaceuticals signed a global license with Ribo Life Science (and Ribocure) to acquire six preclinical siRNA programs in a deal that could reach $4.4 billion in milestones. The upfront...
Atopic dermatitis — Evommune and Nektar post strong Phase II signals, stocks surge
Two mid‑stage studies reported clinically meaningful, durable efficacy signals in atopic dermatitis, triggering sizable share gains. Evommune’s EVO‑301 showed statistically significant EASI...
ILiAD raises $115M to push live attenuated pertussis vaccine toward Phase III
ILiAD Biotechnologies closed an oversubscribed $115 million Series B to advance BPZE1, a live attenuated intranasal pertussis vaccine, toward Phase III development. The financing was led by RA...