A court case filed in the district court of Dallas County, Texas precludes the five companies owned by Steven Warshak - including Berkeley Premium Nutraceuticals - from fraudulently marketing 15 dietary supplements in the state. The banned supplements include male enhancement supplement Enzyte, noted for its "Smiling Bob" commercials. The case also stops deceptive "free trial" offers for the dietary supplements. Under the Feb. 1 settlement, Warshak will pay the state of Texas $350,000 in civil penalties and attorneys' fees. In September 2006 a federal grand jury indicted Berkeley Premium Nutraceuticals, Warshak, his mother and five additional co-conspirators on a total of 112 criminal charges (1"The Tan Sheet," Sept. 25, 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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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.