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PacBio posts 14% Q4 revenue rise — clinical customers and Europe drive growth
Pacific Biosciences reported a 14% year‑over‑year revenue increase in Q4, attributing gains to expanded adoption by clinical customers and stronger demand in Europe. The company said consumables...
CareDx’s AlloHeme posts strong validation — company eyes 2027 commercial launch
CareDx released validation data for AlloHeme, its allogeneic hematopoietic cell transplant surveillance assay, showing 85% sensitivity, 92% specificity and a median 41‑day lead time in detecting...
Quantx closes $85M Series B — oral STAT6 and IL‑17 programs move to clinic
Quantx Biosciences raised $85 million in an oversubscribed Series B to advance two oral immunology candidates: a STAT6 inhibitor and an IL‑17 inhibitor. The company said proceeds will underwrite...
Policy shakeup at HHS and FDA — RFK Jr. tenure and Prasad scrutiny reshape regulation
A year into Robert F. Kennedy Jr.'s leadership at HHS, the agency has enacted sweeping personnel and policy changes that critics say have disrupted established scientific norms. The tenure...
Madrigal buys into siRNA MASH pipeline — $60M up front, $4.4B potential
Madrigal Pharmaceuticals struck a licensing deal with Ribo Life Science (and Ribocure) to acquire global rights to six preclinical siRNA programs targeting metabolic dysfunction‑associated...
Ribbon Bio launches cell‑free long‑DNA service — targets nucleic acid therapeutics
Ribbon Bio unveiled an early‑access program for its cell‑free long DNA manufacturing process, offering synthetic linear DNA products up to ~11 kb with high reported accuracy and no bacterial...
FDA refuses Moderna flu review — industry warns of chilling precedent
The U.S. Food and Drug Administration issued a refusal-to-file (RTF) for Moderna’s mRNA influenza application, prompting immediate pushback from the company and alarm across the vaccine sector....
BridgeBio phase 3 win — infigratinib readies for FDA filing
BridgeBio reported positive top-line results from Propel 3, a global Phase 3 trial of oral infigratinib in children with achondroplasia, meeting its primary endpoint for increased annualized...
MAHA movement outlines anti‑vaccine strategy — policy shifts accelerate
Reports and investigative coverage show the Make America Healthy Again (MAHA) movement and HHS leadership under Robert F. Kennedy Jr. have advanced policy changes that reduce recommended childhood...
Ultragenyx cuts 10% as FDA stalls gene therapy approval
Ultragenyx announced a strategic restructuring that will remove about 10% of its workforce and refocus resources after two failed late‑stage trials and a delayed gene‑therapy approval pathway. The...
CareDx eyes launch of AlloHeme transplant surveillance test
CareDx disclosed validation data from the ACROBAT study showing its AlloHeme cell‑free DNA assay for allogeneic hematopoietic cell transplant surveillance achieved 85% sensitivity and 92%...
Ribbon rolls out cell‑free long‑DNA service — aims at nucleic‑acid developers
Ribbon Bio launched an early‑access program for a cell‑free manufacturing process that synthesizes long linear and circular DNA with claimed high accuracy, addressing demand from cell and gene...
PacBio posts better‑than‑expected Q4 — consumables hit record
Pacific Biosciences reported Q4 revenue of $44.6 million, up 14% year‑over‑year, driven by a record for consumables and growth across clinical market adoption. The company shipped Revio and Vega...
Thermo Fisher inks Datavant deal — secure RWD linkage for trials
Thermo Fisher Scientific’s PPD clinical research unit formed a strategic partnership with Datavant to enable privacy‑preserving linkage of de‑identified research datasets with real‑world patient...
Madrigal buys Ribo siRNAs — $60M now, $4.4B possible
Madrigal Pharmaceuticals signed a global licensing agreement with Ribo Life Science and Ribocure to acquire six preclinical siRNA programs targeting metabolic dysfunction‑associated...
Microbiotica MB‑310 induces remission in phase Ib — promising UC signal
Microbiotica reported positive Phase Ib data for MB‑310, an oral live biotherapeutic for ulcerative colitis, with 12 of 19 treated patients achieving clinical remission versus 3 of 10 on placebo....
FDA refuses-to-file Moderna flu shot: review halted
The FDA issued a refusal-to-file letter for Moderna’s mRNA influenza vaccine application, halting regulatory review. The letter was signed by Vinay Prasad, director of the agency’s office...
BridgeBio’s oral dwarfism drug wins Phase III — filing planned
BridgeBio reported positive top-line results from Propel 3: oral infigratinib improved annualized height velocity in children with achondroplasia versus placebo. The trial met its primary endpoint...
Ultragenyx cuts 10% as FDA requests more manufacturing documents
Ultragenyx disclosed a 10% workforce reduction—about 130 roles—while refocusing resources after two failed late‑stage trials in osteogenesis imperfecta and continuing FDA scrutiny of its gene...
CareDx’s AlloHeme shows high sensitivity — commercial launch eyed
CareDx announced validation data from the ACROBAT observational study for AlloHeme, its allogeneic hematopoietic cell transplant surveillance assay. The assay delivered 85% sensitivity and 92%...