Teva’s Trisenox receives Priority Review for promyelocytic leukemia

Wednesday, September 13, 2017

Teva Pharmaceutical Industries announced the FDA has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of Trisenox (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

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Teva recieves FDA approval of Austedo Tablets for chorea associated with Huntington’s

Wednesday, April 5, 2017

Teva Pharmaceutical Industries has announced that the FDA has approved AUSTEDO (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease (HD). Previously referred to by the developmental name SD-809, AUSTEDOTM is the first deuterated product approved by the FDA and only the second product approved in HD. The product was previously granted Orphan Drug Designation by the FDA.

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Novo Nordisk, Servier, Otsuka, Teva among top sponsors

Wednesday, March 1, 2017

Sponsors have done a good job of maintaining, but not improving, the overall quality of their relationships with investigative sites during the past two years, according to a new CenterWatch survey, but performance gaps have widened across several of the attributes sites identify as the most important for conducting a successful study.

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