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  • AstraZeneca and Eli Lilly and Company (Lilly) today announced they have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial.

  • Xenetic Biosciences, Inc. announced that it has commenced a collaboration with Excivion Ltd. to develop a vaccine against Zika and dengue viruses. As part of the collaboration, Xenetic’s proprietary IMUXEN Technology will be used to develop the vaccine. Excivion is a private UK company that has developed a proprietary antigen design platform for viral vaccines which it is applying to flavivirus infections.

  • Edwards Lifesciences Corporation announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who have been determined by a Heart Team to be at intermediate risk for open-heart surgery. The SAPIEN 3 valve is the first transcatheter aortic valve replacement (TAVR) therapy to obtain this indication in the United States.

  • Innovus Pharmaceuticals, Inc. announced  that its partner Khandelwal Laboratories received the approval of the product licenses for Zestra®, Zestra Glide®, EjectDelay® and Sensum+® from the Indian FDA, The Drugs Controller General (India), and the Directorate General of Health Services to commercialize the products in India.

  • Portola Pharmaceuticals Inc.announced that the MAA for IndexXa™ (andexanet alfa; trade name in the United States is AndexXa™), a Factor Xa inhibitor antidote, has been submitted to the EMA, completed the validation period, and has been accepted for review. IndexXa is in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent or emergency surgery.

  • 22 August 2016
    Cerulean present phase 2 study top line results of CRLX101 & Avastin combo in relapsed RCC

    Cerulean Pharma Inc, a clinical-stage company developing nanoparticle-drug conjugates (NDCs), announced top-line results from the company's phase 2, randomized, multi-center clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) in the treatment of patients with advanced renal cell carcinoma (RCC).

  • Amerigen Pharmaceuticals Limited  announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg).

  • Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 for the treatment of ovarian cancer. Orphan drug designation qualifies Zymeworks for a number of development incentives including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 or ZW33 is approved for this indication.

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