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Latest From PPD, Inc.
Korea’s Clinical Trial Approvals Up 10%, But Still Below Pandemic Peak
South Korea’s clinical trial approvals rebounded in 2023, but remained lower than the peak levels in 2020-21 amid then robust R&D activity related to COVID-19. Last year's tally showed a mix of single-country and multinational trials and reflected the ongoing dominance of oncology in industry pipelines.
China Biotech Interview: BeiGene Co-Founder Wang Eyes Next Big Things
BeiGene co-founder and chair of the major global biotech's Scientific Advisory Board, Dr. Xiaodong Wang, sits down with Scrip in an exclusive audio interview to shed light on the rapid rise of China's biotech innovation, the country's role in BeiGene's global strategy and the next big things to watch.
Trials In Focus: Joint Venture Aims To Simplify Cell Therapy Trials For Smaller Players
CTMC CEO Jason Bock talked to Scrip about the venture between MD Anderson and National Resilience, which provides manufacturing, process development and regulatory support for small cell therapy developers’ preclinical and clinical proof-of-concept studies. Meanwhile, Verge Genomics initiated a Phase Ib study of its AI-discovered drug for ALS; EyePoint and Aviceda dosed patients in their Phase II DME trials; Parexel teamed up with a non-profit cancer research group in Japan; and BARDA selected PPD to run its Phase II platform trial for ARDS.
REMS Vendor Disruptions Prompt Greater US FDA Scrutiny
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.
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