China: Fraud not the only reason 1,193 drug applications were withdrawn; Advaxis shares drop
Just how much fraud is involved in clinical trials in China? Some recent reports suggested that the rate is 83%, but Chinese officials beg to differ. While it’s true that 1,193 applications have been withdrawn following a period of self-examination — out of 1,429 that were put under the spotlight — the government notes that there are plenty of reasons besides fraud for a withdrawal. Why, some just had incomplete or insufficient data on safety and efficacy, which didn’t necessarily rely on fraud. And there were some for “untruthful data,” which could include fraud. The CFDA concludes: “By the end of September, 2016, 117 registration applications have been verified, 30 of which were rejected due to defects with authenticity, accounting for about 2% of the total number of registration applications for self-examination and verification. 27 applications, as well as 11 clinical trial institutions and the CROs suspected of providing fraudulent data have been investigated.”
Shares of Advaxis $ADXS took a hit this morning after the biotech tried to explain the data it had collected in a mid-stage study of axalimogene filolisbac in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix. The biotech had completed stage 1 of the trial and had enrolled 24 patients for stage 2 when the FDA dropped a clinical hold on the work last fall, preventing it from being completed following the death of a patient. The biotech says that the study highlighted a “meaningful improvement in 12-month overall survival rate compared to historical GOG studies.” But investors were stuck on the clinical hold which prevented the trial from wrapping up as planned.
Catalent Pharma Solutions is expanding its operations in Madison, WI, with plans to add 100 new staffers over the next two years. Catalent is spending $34 million on a project that will add 22,000 square feet of operating space.
Sweden’s Oasmia has acquired a preclinical cancer drug from Karo for a batch of stock.