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news.Edison’s EPI-743 gets FDA orphan drug status for Leigh syndrome
Vatiquinone is the International Nonproprietary Name (INN) (or generic name) for the company’s EPI-743 and it is issued by the World Health Organization, which is used to identify
Vatiquinone is the International Nonproprietary Name (INN) (or generic name) for the company’s EPI-743 and it is issued by the World Health Organization, which is used to identify
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
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
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 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
Earlier in 2014, the US Food and Drug Administration (FDA) had approved Pradaxa to treat patients with DVT and PE. The company said that almost one in three
The payment settles charges brought by 45 state attorneys general, while California’s portion of the settlement is around $7.1m. The settlement prohibits the UK drug-maker from providing incentive