Building the Right Team and Resource Model to Support Quality System and Validation Activities
Since life science quality and validation projects can vary widely in scope and complexity, each specific project needs to be evaluated in order to...
Merck and Blackstone Enter R&D Funding Agreement for sac-TMT
Merck, recognized as MSD outside the U.S. and Canada, has announced a funding arrangement with Blackstone Life Sciences to support the development of sacituzumab...
FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults
Johnson & Johnson said the U.S. Food and Drug Administration (FDA) has cleared DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for use as a single-agent treatment...
FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency
UCB, a leading global biopharmaceutical company, has announced that KYGEVVI has received FDA approval for the treatment of adults and pediatric patients diagnosed with...
Lilly, NVIDIA Partner on AI Supercomputer for Drug Research
Eli Lilly and Company has revealed plans to construct what it calls the most powerful supercomputer ever built and operated by a pharmaceutical company,...
FDA Unveils Initiative for Faster Biosimilar Development
The U.S. Food and Drug Administration (FDA) has unveiled a major initiative aimed at cutting both the time and cost required to develop biosimilar...
Novartis ianalumab first drug to reduce disease activity and patient burden in Sjögren’s disease Phase III trials
NEPTUNUS-1 and NEPTUNUS-2 achieved primary objective of reduced disease activity and provided clinically meaningful benefit
Data showed consistent improvements across secondary outcome measures, and a favorable...
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The Future of Digital Health
The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....
Five Best Practices to Deliver Exceptional Multichannel Experiences
A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...
The Impact and Use of Social Media in Pharmacovigilance
Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...