Tasly Group Halts Trading After Adverse Report On Its Cardiotonic Pill
This article was originally published in PharmAsia News
An academic fingered for falsifying his research paper has turned the table on the accuser after Zhejiang University found the real author to be a protégé. Li Lianda, the implicated academic, claimed the allegation was made by an advisor of Tasly Group after Li announced his research on the severe side effects caused by the firm's Cardiotonic Pill. The company asked him not to publish the results but he went ahead, thus he suspected the false paper "exposé" was linked to the incident. Upon media reporting of Li's statement, Tasly Group's share dropped 3.8 percent, leading to an urgent halt in trading. The firm issued a statement that the advisor's accusation was made in his personal capacity and denied any association. It emphasized that the drug has received China State FDA approval after thousands of clinical trials. (Click here for more - Chinese Language)
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China's State FDA has made an official response to the report on Cardiotonic Pill side effects (PharmAsia News, Feb. 9, 2009). Zhang Wei, director general of SFDA's Department of Drug Registration, stated that Cardiotonic Pill is registered as a modified dosage form of Salvia miltiorrhiza tablet. Both the dosage change for the generic drug and the brand drug have been studied by designated research institutes according to the requirements of the registration application. Cardiotonic Pill registration review shows that toxicity testing has been conducted in various phases over different periods, especially since the drug has applied for R&D experiments in the U.S. SFDA said that public release of the National Center for ADR Monitoring will be the most authoritative evaluation for adverse drug reactions. (Click here for more - Chinese language)
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