Asia Spotlight: China Probe Reveals Widespread Data Violations At Major Study Centers
Severe adverse events left unreported, critical data gone missing, subject drugs substituted to pass bioequivalent testing are just some of the wrongdoings disclosed by the China FDA in a rare new report on regulatory transgressions.
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Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval
The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.
Big Pharma CEOs Suggest Policy Changes As They Return To Beijing
Global CEOs of J&J, Pfizer, AbbVie and Takeda were among the top pharma executives attending the China Development Forum in its first in-person meeting in three years, and highlighted a number of pharma-related policy changes they would like to see in China. Meanwhile, a Japanese employee of Astellas has been detained in the country for alleged espionage.
Chinese Biopharma Tycoons Down But Not Out In Latest Global Billionaire Ranking
China continues to dominate the latest list of global billionaires and top execs from domestic pharma firms Hengrui and Hansoh ranked among the wealthiest overall in the country, along with the founder of vaccine maker Zhifei Bio. A number of top Chinese biopharma business executives also featured in the global top 100 billionaires list.