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Radioligand therapy expands: China clears [177Lu] candidate as interest in RLT grows
Sichuan Biokin received China NMPA clearance to start clinical trials of [177Lu]‑BL‑ARC001, marking continued regulatory activity in radioligand therapy (RLT). Separately, a review of RLT in...
Base editing corrects LMNA mutations: cardiac disease prevented in mice
Researchers at the University of Texas Southwestern demonstrated targeted base‑editing strategies that corrected LMNA point mutations in patient‑derived iPSC cardiomyocytes and humanized mouse...
FDA on pace for fewest new‑drug approvals in years: 2025 shortfall tightens timelines
Industry reporting indicates the U.S. Food and Drug Administration is on track to approve the fewest new molecular entities since 2022, leaving more than a dozen companies waiting on regulatory...
Investors back novel oncology and AI drug discovery: Trogenix $95M, Meta‑Flux $2M
Two fundraising rounds illustrate selective investor activity: Edinburgh‑based Trogenix closed a $95 million Series A to advance its Odysseus AAV platform aimed at aggressive solid tumors, and...
FDA flags Novo Nordisk plant: OAI follows inspection tied to CRLs
The FDA has classified Novo Nordisk’s Bloomington, Indiana contract-manufacturing site as “official action indicated” (OAI) after inspection findings linked to complete response letters for drugs...
Regeneron to seek approval: gene therapy restores hearing in children
Regeneron said it will pursue regulatory approval after a clinical study—published in The New England Journal of Medicine—showed meaningful hearing gains in children treated for a congenital form...
Moderna previews melanoma antigen therapy: data behind program shift
Moderna released early clinical data showing responses in melanoma patients treated with its cancer antigen therapy (mRNA-4359) in combination with a PD-1 inhibitor, and separately posted Phase...
Tvardi’s STAT3 candidate fails Phase 2 – stock tumbles
Tvardi Therapeutics reported a Phase 2 failure for its STAT3 inhibitor in idiopathic pulmonary fibrosis after high dropout rates and efficacy that resembled placebo, triggering a sharp decline in...
BMS buys Orbital Therapeutics: $1.5B bet on in vivo cell therapy
Bristol Myers Squibb has agreed to acquire Orbital Therapeutics for $1.5 billion to secure an in vivo cell therapy program aimed at autoimmune disease. The deal positions BMS alongside other large...
Bio‑Techne and Oxford Nanopore extend partnership: clinical nanopore assays planned
Bio‑Techne expanded its collaboration with Oxford Nanopore Technologies to develop and commercialize a broader portfolio of targeted enrichment sequencing kits for screening and diagnosing...
DIAL promoter editing: programmable control creates stable transgene setpoints
Researchers published a programmable promoter-editing framework named DIAL in Nature Biotechnology that converts transient inputs into heritable, stable setpoints of transgene expression in...
Cambridge ‘hematoids’: lab-grown embryo models make blood stem cells
Scientists at the University of Cambridge reported creation of three‑dimensional embryo‑like structures—termed hematoids—that recapitulate aspects of very early human development and produce blood...
Radioligand therapy momentum: Biokin cleared for Lu‑177 trial in China
China’s NMPA cleared Sichuan Biokin to begin clinical trials of [177Lu]‑BL‑ARC001, advancing a radioligand candidate into the clinic. The clearance comes amid a broader revival of radioligand...
Senators press for patent clarity: PERA hearing spotlights biotech IP risk
Senators held a hearing on the Patent Eligibility Restoration Act (PERA), with proponents arguing the bill is essential to restore clarity after Supreme Court rulings that muddied patent...
BMS buys Orbital Therapeutics for $1.5 billion – in vivo cell therapy bet
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion to add an in vivo cell therapy program aimed at autoimmune disease to its pipeline. MedCity News reported the deal...
Excellergy raises $70 million – challenger to Xolair with multi-mechanism allergy drugs
Excellergy closed a $70 million Series A to advance a portfolio of multipronged allergy therapeutics the company says could outperform current biologics such as Xolair. Company statements and a...
Tvardi’s STAT3 drug flunks Phase 2 – trial hit by high dropouts and safety issues
Tvardi Therapeutics reported a Phase 2 failure for its STAT3 inhibitor TTI‑101, citing high dropout rates tied to side effects and lack of efficacy versus placebo. Financial market reactions were...
Regeneron to seek FDA approval: gene therapy restored hearing in NEJM children study
Regeneron announced plans to file for FDA approval after publishing New England Journal of Medicine data showing its gene therapy restored meaningful hearing in nine of 12 children born deaf from...
Gilead, Arcus report 27‑month OS from anti‑TIGIT cohort – Phase 3 stays on track
Gilead and Arcus presented mid‑stage data showing almost 27 months median overall survival for a digestive tract cancer cohort treated with an anti‑TIGIT regimen, data the companies say support...
Meta‑Flux raises $2 million seed – multiomics + neural nets to predict drug effects
Meta‑Flux closed a $2 million seed round to build a platform that integrates multiomics, neural networks and biological modeling to forecast therapeutic and safety outcomes preclinically. The...