By Laura Helbling
Pharmaceutical companies leave no stone unturned when it comes to finding outside experts to help support a critical NDA with...
Forest's Unlikely Co-Sponsor For Ceftaroline Review: FDA Steps In
FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data. Reprinted from The RPM Report, November 2010.
More from Archive
More from In Vivo
• By
A discussion with Karen Harris, CFO of the Alzheimer's Drug Discovery Foundation, about the foundation's investment strategy, biotech and investor sentiment at the recent BIO conference and what innovations give her hope for Alzheimer's patients.
• By
Against a backdrop of shifting trade policies, the end of multilateral market approaches and renewed focus on supply chain resilience, medtechs are doubling down on innovation in products and processes – using AI – and keeping unmet needs and outcomes in the center of the target.
• By
While biopharma companies experiment with genAI, agentic AI is rapidly shifting the work paradigm towards one of autonomous digital workers that can handle entire process flows.