Aeterna Zentaris Inc., a specialty biopharmaceutical company, is planning to conduct a new, confirmatory phase 3 clinical study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (AGHD), as well as a dedicated thorough QT study to evaluate the effect of Macrilen on myocardial repolarisation.
Sagent Pharmaceuticals, Inc., a specialty pharmaceutical company has launched Vancomycin hydrochloride for injection, USP, an anti-infective, in a 10 gram preservative-free pharmacy bulk package presentation.
The US Food & Drug Administration (FDA) has granted Fast Track designation to Exelixis, Inc's cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC). Cabozantinib is the Exelixis' lead compound . Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer.
Dr. Reddy's Laboratories and its subsidiary, Promius Pharma™, LLC announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the U.S. Food and Drug Administration (US FDA).
India is examining whether to take up with World Trade Organisation (WTO) the European Union's (EU) suspension order for sale of about 700 generic drugs which were approved based on clinical trials by pharma major GVK Biosciences.
Sun Pharmaceutical Industries has inked a pact with Israel's Technion university to develop anti-cancer drugs. The subsidiaries of the Mumbai-based drug firm and Technion - Israel Institute of Technology have entered into an exclusive worldwide research and license agreement, Sun Pharma said in a statement.
Aurobindo Pharma has received the final approval from the US Food and Drug Administration to manufacture and market Atracurium Besylate injection in single and multi-dose vials in the US market.
Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical group active in global markets, announced that EU has approved its new room-temperature-stable formulation of Pabal (carbetocin) for intravenous (IV) administration.
Novo Nordisk opens a new manufacturing facility in Russia for formulation and filling of modern insulin for the treatment of diabetes. The production will cover both Penfill® cartridges and FlexPen® prefilled insulin injection pens for the Russian market.
Biocon Ltd, Asia's premier biopharmaceuticals company, announced that its Insulin Glargine has been approved by COFEPRIS, the Mexican health authority, through its partner PiSA Farmaceutica (PiSA).
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