Bio Pharma Dive
SEPTEMBER 14, 2024
Results presented at ESMO showed tumor response rates that matched the bar set by analysts for success. But they may not yet be enough to dispel doubts around TIGIT as a target.
pharmaphorum
SEPTEMBER 14, 2024
ESMO 2024 began on Friday 13th September. Prof Andres Cervantes discussed how building trust has been a several generation development, following five decades of effort in the oncological space.
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Fierce Pharma
SEPTEMBER 14, 2024
AstraZeneca’s Imfinzi recently became the first PD-1/L1 inhibitor to deliver a patient survival win in muscle-invasive bladder cancer (MIBC). | AstraZeneca’s detailed data show exactly how Imfinzi became the first PD-1/L1 inhibitor to deliver a patient survival win in muscle-invasive bladder cancer. But the win came from a perioperative regimen, a trial design that’s been criticized by the FDA in lung cancer.
Cloudbyz
SEPTEMBER 14, 2024
The Clinical Trials Transformation Initiative (CTTI) advocates for improving clinical trial quality and efficiency, with a focus on patient safety and reliable outcomes. Quality by Design (QbD) aligns with these goals by integrating quality into the trial process from the start. Using a metrics-driven approach, QbD reduces risks and enhances trial success.
Fierce Pharma
SEPTEMBER 14, 2024
In 2021, the FDA blasted Merck for using a premature endpoint to pursue a Keytruda approval in early-stage triple-negative breast cancer (TNBC). | In 2021, the FDA blasted Merck for using premature data to pursue a Keytruda approval in early-stage triple-negative breast cancer. Now, the PD-1 inhibitor has gold-standard overall survival data to back its case.
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