A federal grand jury indicted Berkeley Premium Nutraceuticals, the company's President Steve Warshak, his mother and five additional defendants and co-conspirators on a total of 112 criminal charges Sept. 20. Warshak engaged in conspiracy to commit mail, wire and bank fraud, money laundering, conspiracy to obstruct proceedings before FTC and other criminal acts, U.S. Attorney for the Southern District of Ohio Gregory Lockhart alleges. Warshak, et al., defrauded consumers of more than $100 mil., according to Lockhart. If convicted, the defendants are expected to forfeit assets including several parcels of land, vehicles, and the contents of numerous bank and investment accounts, according to the filing. Berkeley, marketer of male enhancement supplement Enzyte, settled with the Attorney Generals of six states in March for $2.5 mil. (1"The Tan Sheet" March 6, 2006, p. 8). Earlier this month, the Cincinnati, Ohio-based firm issued a press release asserting they had reduced consumer complaints by 90% (2"The Tan Sheet" Sept. 11, 2006, In Brief)....
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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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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.