MiMedx Sees Filing of BLAs As Competitive Advantage

While MiMedx disagrees with the FDA’s reasoning for requiring BLAs — and, hence, clinical trials — for its regenerative, human cellular and tissue-based products (HCT/Ps), the company says it will oblige the agency to set precedence for future products developed by competitors. Read More

Year in Review: Global Transparency Initiatives Dominate Busy 2013

The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead. Read More

FDA Issues Guidances on Gene/Cellular Therapies

The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More