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Millennium Pharmaceutical’s received another victory in its efforts to bolster the use of its blockbuster oncology drug Velcade, receiving FDA approval for a new indication for previously untreated patients with mantle cell lymphoma. Read More
A European regulatory committee is recommending stronger restrictions on the use of valproate drugs by women and girls, citing risks of malformations and developmental problems during pregnancy. Read More
A key European health committee didn’t find enough evidence to confirm that testosterone-replacement (TRT) products create higher heart attack risk, but it did agree with FDA advisors that labeling for such products should change. Read More
Drugmakers in Europe are calling for the establishment of a new clinical trial portal and database, rather than modifying existing systems, to meet requirements for a single, streamlined submission process for clinical trial applications. Read More
Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More