Get the Daily Brief
Latest Biotech News
Lilly expands GLP-1 franchise with Brenipatide Phase 1 dose selection
Eli Lilly presented early clinical findings for brenipatide, a once-weekly dual GIP/GLP-1 receptor agonist, targeting central nervous system and inflammatory pathways linked to reward, addiction,...
FDA approval for Lilly’s oral SERD combination in breast cancer
The FDA approved Eli Lilly’s oral SERD-based combination regimen, including Inluriyo (oral selective estrogen receptor degrader), for certain second-line metastatic breast cancer patients. The...
CAR T safety risk assessment: autoimmune mechanisms and IEC-HS
Biotech developers working on autoimmune CAR T therapies are testing assumptions about the safety thesis after concerns surfaced around IEC-HS risk (immune effector cell–associated hemophagocytic...
Xenon Pharmaceuticals pauses depression trials over neuropsychiatric adverse events
Xenon Pharmaceuticals disclosed a voluntary pause in enrollment for its azetukalner trials in major depressive disorder and bipolar disorder after neuropsychiatric adverse events emerged. The...
European regulator momentum: EMA CHMP endorses eight new medicines
The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed eight new medicines in its September recommendations, including two ovarian cancer therapies and a potential first oral...
European regulator backs Novo hemophilia A preventive therapy
Novo received CHMP backing for its preventive hemophilia A preventive drug, adding to a broader September slate of CHMP recommendations. Alongside the hemophilia indication, the committee...
Electra Therapeutics launches $350M IPO for sHLH monoclonal antibody program
Electra Therapeutics priced an upsized initial public offering raising $350 million to fund late-stage development of ipsoprubart, a pan-SIRP monoclonal antibody in secondary hemophagocytic...
CMS expands ACCESS model to additional chronic conditions
CMS broadened its ACCESS model, expanding the outcomes-based payment framework starting in spring 2027 to include heart failure, COPD, substance use disorders, and tobacco cessation. The model...
Venture-backed neuroscience spinout targets Parkinson’s apathy
Palomar Labs spun out Ariadne Bio to develop AB-300, a clinical-stage non-hallucinogenic 5-HT2A receptor agonist for apathy in Parkinson’s disease. The venture studio said Ariadne Bio is led by...
Gene therapy approval for Sanfilippo type A
The FDA has approved Ultragenyx’s gene therapy rebisufligene etisparvovec (Fayuvi) as a disease-modifying treatment for Sanfilippo syndrome type A (MPS IIIA), marking the first approval for the...
Lilly’s oral SERD expands breast cancer options
The FDA approved Eli Lilly’s oral SERD combination therapy Inluriyo for certain patients with second-line metastatic breast cancer. The regimen pairs Lilly’s selective estrogen receptor degrader...
Lilly’s brenipatide posts early CNS and psychiatric dosing data
Eli Lilly presented early clinical results for brenipatide, its once-weekly dual GIP/GLP-1 receptor agonist, showing dose-selection support across substance use, psychiatric, and immunologic...
CAR T safety focus on autoimmune risk
Investigators are testing the “fatal toxicities” question behind autoimmune CAR T safety assumptions, with developers pointing to manufacturing speed, construct design, and patient biology as...
Ultragenyx pricing and gene-therapy market implications
Ultragenyx’s latest Sanfilippo approval arrives alongside reports that the therapy will cost $4 million per patient, adding another high-priced gene therapy to the US market. The company’s second...
Xenon pauses depression trial over neuropsychiatric adverse events
Xenon Pharmaceuticals paused enrollment in trials evaluating azetukalner in major depressive disorder and bipolar disorder after neuropsychiatric adverse events emerged. The company said...
EMA backs multiple new medicines including ovarian cancer and HS
The EMA’s CHMP recommended eight new medicines in its September outlook, including two ovarian cancer therapies and a potential first oral option for hidradenitis suppurativa. The committee also...
Bioprocessing scale-up: GMP SmartScale platform launch
GBI Biomanufacturing is preparing to launch its SmartScale GMP Solutions platform at BioProcess International East 2026, aiming to deliver GMP material for first-in-human studies faster....
Neuroscience drug development spinout targets Parkinson’s apathy
Palomar Labs spun out Ariadne Bio to develop AB-300, a clinical-stage non-hallucinogenic serotonin 2A (5-HT2A) receptor agonist targeting apathy in Parkinson’s disease. The venture studio said the...
Lilly expands CNS research partnership with QurCan
Eli Lilly signed a research and collaboration agreement with QurCan Therapeutics to develop therapies for central and peripheral nervous system diseases. The deal is reported at $237 million,...
FDA greenlights first disease-modifying gene therapy for Sanfilippo A
The FDA approved Ultragenyx’s single-dose gene therapy rebisufligene etisparvovec (Fayuvi) for Sanfilippo syndrome type A, marking the first treatment approved to address the underlying cause of...