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Microbiotica’s live microbiome pill posts positive Phase Ib remission data
Microbiotica reported positive Phase Ib results for MB‑310, an oral live biotherapeutic for ulcerative colitis. In the randomized study, 12 of 19 treated patients achieved clinical remission...
Madrigal buys six Ribo siRNA programs — deal could top $4.4B
Madrigal Pharmaceuticals struck a licensing deal with Suzhou Ribo Life Science and Ribocure to acquire six preclinical siRNA programs targeting metabolic dysfunction‑associated steatohepatitis...
Viking advances oral GLP‑1/GIP into phase III obesity trial
Viking Therapeutics announced plans to advance its oral dual GLP‑1/GIP receptor agonist VK‑2735 into a Phase III obesity program, targeting a Q3 2026 start. VK‑2735 is being developed in both...
Quantx closes $85M Series B to start clinical trials for oral immunology drugs
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two oral small‑molecule immunology candidates into the clinic: a STAT6 inhibitor and an IL‑17 inhibitor. The financing...
ILiAD raises $115M to push intranasal pertussis vaccine toward Phase III
ILiAD Biotechnologies secured $115 million in a Series B financing led by RA Capital to advance BPZE1, a live attenuated intranasal pertussis vaccine, into pivotal testing. The company plans a...
Thermo Fisher and Datavant partner to link clinical RWD at scale
Thermo Fisher Scientific’s PPD clinical research business partnered with Datavant to enable privacy‑preserving tokenization and linkage of real‑world data across more than 350 partners and 80,000...
FDA refuses to review Moderna flu vaccine: rare refuse-to-file
The FDA issued a refuse-to-file (RTF) decision for Moderna’s mRNA influenza vaccine mRNA-1010, marking an uncommon regulatory rebuke for a high-profile vaccine developer. Moderna said the agency...
BridgeBio’s oral drug wins phase III – infigratinib speeds growth in dwarfism
BridgeBio disclosed positive top-line results from Propel 3, a global Phase 3 trial testing oral infigratinib in children with achondroplasia. Infigratinib demonstrated a statistically significant...
Madrigal inks $60M deal with Ribo – adds siRNA MASH portfolio
Madrigal Pharmaceuticals agreed a global licensing partnership with Suzhou Ribo Life Science and Ribocure Pharmaceuticals to acquire six preclinical siRNA programs targeting metabolic...
ILiAD raises $115M to push pertussis vaccine into phase III
ILiAD Biotechnologies closed a $115 million Series B led by RA Capital to advance its live attenuated intranasal pertussis vaccine BPZE1 toward Phase III testing. ILiAD plans a pivotal human...
CareDx’s AlloHeme shows high sensitivity and long lead time in transplant surveillance
CareDx reported validation data from the ACROBAT observational study supporting AlloHeme, its cell‑free DNA assay for allogeneic hematopoietic cell transplant surveillance. AlloHeme achieved 85%...
Seres cuts 30% of staff, pauses lead program in strategic reset
Microbiome specialist Seres announced a strategic reboot that will cut roughly 30% of its workforce and pause its lead program while refocusing resources on earlier‑stage, immunology‑focused...
Thermo Fisher, Datavant partner to link RWD across 80,000 sites
Thermo Fisher Scientific’s PPD clinical research unit struck a strategic partnership with Datavant to enable privacy‑preserving linkage of real‑world data across more than 350 RWD partners and...
PacBio posts Q4 beat; consumables record and SPRQ‑Nx planned
Pacific Biosciences reported Q4 revenue of $44.6 million, up 14% year‑over‑year, driven by record consumables sales and growth in clinical market adoption. PacBio shipped 21 Revio instruments and...
Microbiotica’s oral live biotic induces remission in UC phase Ib – 12 of 19 patients
Microbiotica announced positive Phase Ib results for MB‑310, an orally administered live biotherapeutic for ulcerative colitis. In the randomized study, 12 of 19 treated patients achieved clinical...
Ribbon launches cell‑free long‑DNA program – early access for therapeutic makers
Ribbon Bio rolled out an early‑access program for a cell‑free version of its MiroSynth long‑DNA platform, offering synthetic linear DNA molecules up to ~11 kb with reported accuracy above 90% and...
FDA refuses to review Moderna flu vaccine — rare refusal-to-file
The FDA issued a refusal-to-file (RTF) letter for Moderna’s mRNA seasonal influenza application, stopping formal review of mRNA-1010 despite no direct safety or efficacy findings cited in the...
FDA’s vaccines chief overrules staff — regulators tighten vaccine gatekeeping
Internal dissent at the FDA surfaced after agency leadership, led by Vinay Prasad, overruled vaccine-review teams on Moderna’s submission—actions that industry sources say changed the outcome of a...
BridgeBio’s infigratinib clears Phase 3 — approval path on deck
BridgeBio reported positive top-line results from the global Phase 3 Propel 3 trial of oral infigratinib in children with achondroplasia, meeting the primary endpoint of increased annualized...
Madrigal inks $60M Ribo deal — siRNAs added to MASH arsenal
Madrigal Pharmaceuticals signed an exclusive licensing agreement with Suzhou Ribo Life Science and Ribocure for six preclinical siRNA programs targeting metabolic dysfunction-associated...