FDAnews Drug Daily Bulletin

The FDA has approved Eisai’s Fycompa tablets to treat partial-onset seizures in epilepsy patients ages 12 and older.

The European Medicines Agency (EMA) will soon allow biosimilars sponsors to reference biologics made outside the European Economic Area (EEA) in some preclinical and clinical studies required for approval.

The NIH is launching an online database of about 700 prescription and OTC drugs that will automatically forward cases of drug-induced liver damage to the FDA’s MedWatch adverse event reporting program.

A New York federal judge refused to throw out a patent suit Purdue Pharma brought against KVK-Tech over plans to market a generic version of  painkiller OxyContin, ruling KVK had worked on the marketing plans.

Patients with Crohn’s disease who have failed to respond adequately to anti-tumor necrosis factor (anti-TNF) treatment may benefit from the monoclonal antibody ustekinumab, results of a double-blind, placebo-controlled trial suggest.

GlaxoSmithKline’s venture capital fund is seeking to invest in a biotechnology company that has both a brain-imaging dye to detect warning signs for Alzheimer’s disease and a drug treatment for the ailment.

Celgene International announced that its Phase III, multi-center, randomized, open-label study of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board.

Pfizer is considering buying NextWave Pharmaceuticals, a company that develops a liquid attention deficit hyperactivity disorder drug.

The insignificant results of the dengue fever vaccine trial lead by the Sanofi Pasteur pharmaceutical company has not only shocked its clinical professionals but also the pharmaceutical experts of the Biotech field.