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FDA determined that the ANDA is bioequivalent therefore, therapeutically equivalent to the reference listed drug, Cyklokapron – tranexamic acid injection solution. The injection is indicated in hemophilia patients

The terms of the agreement are unchanged from those disclosed by the two firms in December 2013. As part of the deal, Actavis will grant Zydus an exclusive

With this extension the ‘498 patent will now expire 30 June 2023 and the patent is directed to reduced polysaccharide iron oxide complexes, including ferumoxytol. The ‘498 patent

TCR-based product candidates are designed to recognize antigens irrespective of their cellular localization and as presented by the major histocompatibility complex (MHC) on the tumor cell. The NY-ESO-1

Xeris’ G-Pen Mini (glucagon injection), a room-temperature stable glucagon product, is intended to be an effective and convenient treatment for mild-to-moderate hypoglycemia or low blood sugar. Currently, glucagon

The results will also appear in a forthcoming print issue of the journal. The authors note that ESTABLISH-2 was the first prospectively designed clinical trial consistent with the

The biopharmaceutical firm is focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones. The company said that

Eloctate [antihemophilic factor (recombinant), Fc fusion protein] is the first haemophilia A therapy with prolonged circulation in the body. It reduces the frequency of bleeding episodes with prophylactic

The API will be manufactured in ScinoPharm’s plant in Changshu, China. This cooperation not only demonstrates Taiwan’s international competitive strength in new drug development, but also sees the