Securities class actions filed against supplement firm and its officers in Islip, N.Y. federal court on behalf of purchasers of Twinlab stock between April 27, 1999 and Nov. 15, 2000. The lawsuits generally allege defendants issued materially false and misleading financial statements and misrepresented sales growth potential, particularly for herbals. The complaints also assert the firm overstated its physical inventory, and that Twinlab stock was artificially inflated as a result of these disclosure violations. On Nov. 15, Twinlab announced product returns from "major customers" and "inventory reduction" in the herbals and sport nutritional markets forced it to lower FY 2000 projections. The company's 10-Q filing with SEC had been delayed due to inventory discrepancies (1"The Tan Sheet" Nov. 20, p. 5)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
