News

PharmTech7h
Poor API Quality Threatens a Healthy Supply
The API is, one might say, the most important element in a pharmaceutical product. Poor-quality APIs that do not meet potency ...
Rare Disease Industry Awaits FDA Chief’s New Drug Pathway Plan
FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...
STAT3dOpinion
How to stop the shift of drug discovery from the U.S. to China
U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...
Modern clinical trials—apply a mix of co-innovation and best practices to improve productivity and drive ROI
By embracing a mix of co-innovation and best practices, stakeholders can boost productivity, streamline clinical trials, and ...
Physician's Weekly4d
Has FDA’s Drug Development Tools Qualification Program Improved Drug Development?
Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...
The Manila Times16h
IASO Bio Receives Orphan Drug Designation from the Saudi Food and Drug Authority for Equecabtagene Autoleucel
IASO Biotherapeutics ('IASO Bio'), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced ...
Nature17d
The impact of accelerated drug marketing registration procedures on the review and approval of new drugs in China
Accelerated drug development and approval pathways ... including the 2015 “Opinions on the Reform of Review and Approval Process for Drugs and Medical Devices,” and the 2020 revision of ...
High-resolution 3D imaging reveals enzyme activity differences and drug effects in whole organs
It is now possible to obtain three-dimensional, high-resolution images of enzyme activity in tissue samples or whole ...
Iambic Announces Enchant v2, its Next Generation AI Model for Predicting the Clinical Viability of Drug Discovery Programs
Iambic, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, published on major advances to Enchant, Iambic’s ...