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Chemo can be brutal. This FDA effort aims to make it less so.
The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-wrote an editorial in ...
GlobalData on MSN4mon
Project Optimus: helping or hindering cancer drug development?
Agency eyes have zeroed in on oncology, with the FDA Oncology Center of Excellence (OCE) introducing frameworks such as ...
ascopubs.org11d
Combining Response and Toxicity Data to Implement Project Optimus
The FDA Oncology Center of Excellence introduced Project Optimus with goals that included communications of expectations, opportunities for direct discussions between the FDA and sponsors, and the ...
pharmaphorum8d
Better balance of cancer treatment efficacy and toxicity
The US Food and Drug Administration’s (FDA) Oncology Center of Excellence officially announced its Project Optimus initiative draft guidance in January 2023, and pharmaceutical and biotechnology ...
BlackDoctor11d
Why We Need Patient-Centered Dosing in Clinical Trials
A recent discussion on BlackDoctor.org between cancer advocates and medical professionals highlighted the need for more ...
BioSpace13d
ESMO 2024 Preview: Bispecifics and TIGITs Among the Hottest Topics in Oncology
Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand ...
Wall Street Journal24d
FDA Wants Safer Cancer Drugs, but Some Startups Fear Unintended Consequences
For decades drugmakers have taken a more-is-more model when dosing cancer drugs in clinical trials. U.S. regulators want them to reconsider that approach. Companies with cancer drugs in clinical ...
Yahoo Finance25d
Processa Pharmaceuticals Provides Product Pipeline and Financial Update
In addition, Processa utilizes its Regulatory Science Approach, including the principles associated with FDA’s Project Optimus Oncology initiative, in the development of its NGC drug products to ...
ascopubs.org19d
Exposure-Response–Based Multiattribute Clinical Utility Score Framework to Facilitate Optimal Dose Selection for Oncology Drugs
To validate the framework, data were leveraged from over 50 oncology programs from 2019 to 2023 on the basis of FDA new drug application/biologics license application review packages and/or related ...
The Express Tribune6d
FDA prepares to launch Rs70b metro bus project
The Faisalabad Development Authority (FDA) has intensified efforts to implement a Metro Bus Service system in Faisalabad, with an estimated cost of Rs70 billion. The project, green-lit by the ...
Medscape4d
Role of FDA's Drug Information Centers
The primary distinction is that neither of FDA's DICs provides medical advice that deviates from FDA-approved prescribing information. As a result, these DICs do not necessarily conduct extensive ...