Drug Development
Treatment with the TROP2 ADC sac-TMT led to a 70% objective response rate and progression-free survival was “significantly improved” as compared to placebo—the second positive readout for the asset this week.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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The pharma giant’s anti-PD-1 therapy met its dual primary endpoint of overall survival as a treatment regimen for non-small cell lung cancer patients, as the FDA’s Oct. 16 PDUFA date looms.
Both low and high doses of Akero Therapeutics’ lead candidate efruxifermin failed to significantly outperform placebo at improving liver fibrosis without worsening non-alcoholic steatohepatitis.
Patients treated with Xenon Pharmaceuticals’ investigational potassium channel opener XEN1101 experienced a significant and dose-dependent reduction in seizure frequency.
At the six-month follow-up, about 40% of patients treated with Newron Pharmaceuticals’ evenamide improved so much that they no longer meet the Phase II study’s original eligibility criteria.
Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment.
Keytruda’s winning streak in bladder continues with positive data from the Phase III AMBASSADOR study, showing significantly better disease-free survival in muscle-invasive urothelial carcinoma.
Patients with treatment-resistant depression treated with Johnson & Johnson’s Spravato were significantly more likely to reach remission and stay relapse-free for up to 32 weeks.
Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible.
The French pharma paid $500 million upfront, with up to $1 billion in future milestone payments, to co-develop and co-commercialize Teva’s Phase II anti-TL1A antibody for inflammatory bowel disease.
Its reversible nature offers the potential for RNA editing to go beyond rare diseases, eliciting excitement and buy-in from large pharmas like GSK and Eli Lilly.