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.’
The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.
Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.
