Get the Daily Brief
Latest Biotech News
Hengrui and Kailera report obesity drug phase 3 success in China
Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics disclosed positive Phase 3 trial results for their dual GLP-1/GIP receptor agonist obesity drug, HRS9531, in a China-based study....
FDA scrutiny and advisory meetings on GSK's Blenrep for myeloma
GSK's antibody-drug conjugate Blenrep, intended for relapsed/refractory multiple myeloma, faces regulatory uncertainty as the FDA questions sufficiency of data supporting its market re-entry. An...
Global neurodegeneration proteomics consortium releases major datasets
The Global Neurodegeneration Proteomics Consortium (GNPC) unveiled the world's largest proteomic dataset related to dementia, incorporating over 250 million unique protein measurements from more...
Open-source RT-LAMP assay provides low-cost pathogen detection for LMICs
Researchers from the Vienna BioCenter and University of Ghana developed a freeze-dried, open-source reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for SARS-CoV-2...
Ultragenyx gene therapy faces FDA manufacturing rejection
The FDA issued a complete response letter (CRL) to Ultragenyx Pharmaceutical denying approval for its AAV-based gene therapy UX111 for Sanfilippo syndrome type A, due to manufacturing process...
Takeda’s orexin receptor agonist clears Phase 3 trials in narcolepsy
Takeda Pharmaceutical’s oral orexin receptor 2-selective agonist, oveporexton (TAK-861), achieved all primary and secondary endpoints in two Phase 3 trials for narcolepsy type 1. The compound...
Sino Biopharm acquires LaNova Medicines for up to $951M
Chinese pharmaceutical company Sino Biopharmaceutical announced the acquisition of the remaining 95% stake in cancer drug developer LaNova Medicines for up to $951 million. LaNova, based in...
Novel treatments and strategies emerge in cancer and infectious disease
Recent advances include Imugene’s off-the-shelf CD19 CAR T therapy demonstrating a 75% response rate in diffuse large B-cell lymphoma patients during a phase Ib trial, showcasing promise for...
Sino Biopharm Completes $951M Buyout of LaNova Medicines
Sino Biopharmaceutical has acquired the remaining 95% stake in Shanghai-based cancer drug developer LaNova Medicines in a deal valued at up to $951 million. LaNova, which had licensed multiple...
Hengrui and Kailera’s Obesity Drug Shows 18% Weight Loss in Phase 3
Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics announced positive Phase 3 results for their dual-acting GLP-1/GIP receptor agonist, HRS9531, in Chinese patients with obesity. Trial...
FDA Declines Ultragenyx Gene Therapy Approval Over Manufacturing Issues
Ultragenyx Pharmaceutical received a complete response letter from the FDA rejecting its AAV-based gene therapy UX111 for Sanfilippo syndrome type A, citing manufacturing concerns related to the...
Global Neurodegeneration Consortium Identifies Novel Protein Biomarkers
The Global Neurodegeneration Proteomics Consortium (GNPC) published a series of papers unveiling unique plasma protein signatures across Alzheimer's, Parkinson's, frontotemporal dementia, and...
Takeda’s Orexin 2 Receptor Agonist Secures Dual Phase 3 Wins in Narcolepsy
Takeda Pharmaceutical announced that its oral orexin receptor 2-selective agonist, oveporexton (TAK-861), achieved all primary and secondary endpoints in two Phase 3 randomized, placebo-controlled...
Blueprint Medicines Acquired by Sanofi in $9.1B Mast Cell Therapy Deal
Sanofi has secured Blueprint Medicines for $9.1 billion upfront, gaining access to the oral tyrosine kinase inhibitor Ayvakit (avapritinib) approved for systemic mastocytosis and a robust pipeline...
CRISPR Guide RNA Design Shown to Exhibit Ancestry Bias in Cancer Screens
Analysis by Broad Institute researchers revealed that CRISPR-Cas9 guide RNAs used in large-scale genome-wide cancer dependency screens perform unevenly across cell lines derived from different...
Merck Advances Once-Monthly Oral HIV Prevention Pill into Phase 3 Trials
Merck & Co. has initiated Phase 3 studies of MK-8527, an investigational once-monthly oral pill for HIV pre-exposure prophylaxis (PrEP). Trials will enroll populations at elevated risk of HIV-1...
Innovative Microbiome-Dendritic Cell Interaction Spurs Antitumor Immunity
A Nature 2025 study identified a novel gut bacterial strain, YB328, that surpasses known commensals in activating and reprogramming bone-marrow-derived dendritic cells (BMDCs), key orchestrators...
Bio-Techne Partners with Spear Bio to Distribute Neurology Biomarker Immunoassays
Bio-Techne announced a strategic collaboration with Spear Bio to distribute its sensitive immunoassays detecting low-abundance neurological biomarkers including phosphorylated tau 217 and 231,...
AstraZeneca's hypertension drug baxdrostat posts positive pivotal trial
AstraZeneca announced successful results from its BaxHTN phase III trial where the aldosterone synthase inhibitor baxdrostat significantly reduced blood pressure in patients with uncontrolled or...
Ultragenyx's gene therapy for Sanfilippo syndrome hits manufacturing setback
Ultragenyx Pharmaceutical received a complete response letter from the FDA due to manufacturing process concerns for its gene therapy UX111 targeting Sanfilippo syndrome type A. While the agency’s...