SHANGHAI – Although China still has a way to go to approve any CAR T therapy, clinical development is robust with various targets being studied, and the regulatory environment is improving, cell therapy experts said at the Chinatrials 12 Summit.
According to an analysis conducted by BioWorld of the third-quarter 2019 financial reports filed by the top 100 public biopharmaceutical companies ranked by market cap, and excluding big pharma companies, the amount that was invested in research and development (R&D) in the period increased almost 70% compared to the same period in 2018.
The FDA has typically used real-world evidence (RWE) as a way of monitoring safety issues post-approval, especially through the Sentinel Initiative, which started in response to the FDA Amendments Act of 2007.
“We’re surprised by this outright failure as well as the lack of an investor call to discuss the most significant development in the history of the company.”
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously concluded that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl).
Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways in October 2019.
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