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  • Shire plc  announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. Shire is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT), a protein which is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a serious, chronic liver disease for which there are currently no approved drugs. 

  • Pfizer Inc. announced top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third phase 3 study of Xeljanz (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies. 

  • Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider, PCT, with a select therapeutic development pipeline, announces that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of type 1 diabetes mellitus (TID), making it the first known therapeutic candidate for treatment of T1D to receive the designation. 

  • ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for RI-002, an Intravenous Immune Globulin (IVIG), for the treatment of patients with Primary Humoral Immunodeficiency Disease (PIDD). 

  • 1 August 2016
    Novotech looking for Senior/ Clinical Data Manager

    Headquartered in Australia and focused exclusively on the Asia Pacific, Novotech is internationally recognized as a leading regional CRO. With the increasing pace of globalisation in drug development, Novotech’s expertise in the vibrant and fast growing Asian region has been instrumental in the success of hundreds of phase I-IV clinical trials from Australia to India.
    Our highly experienced 140 strong staff based in 8 countries and 15 locations across the region provide access to patients from a population base of over 1.5 billion people. This breadth of reach, supported by the most sophisticated market data commercially available, enables us to conduct extremely thorough feasibility assessments for almost any study.

    Post: Senior/Clinical Data Manager

  • Zealand Pharma (Zealand), a biotechnology company, announces that the U.S. Food and Drug Administration (FDA) has granted approval of lixisenatide for the treatment of adults with type 2 diabetes. Lixisenatide, a once-daily prandial GLP-1 receptor agonist, was invented by Zealand and global development and commercial rights are licensed to Sanofi. 

  • CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the Taiwan Food and Drug Administration (TFDA) has approved the Investigational New Drug (IND) application for a Phase I/II clinical study of CAN-008, plus temozolomide (TMZ), during and after radiation therapy, in patients with newly-diagnosed glioblastoma multiforme (GBM). The study design  consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II trial will evaluate efficacy and safety. The combined Phase I/II trial will enroll a total of approximately 55 patients.  The Phase I portion of the trial will commence in August 2016. 

  • GlaxoSmithKline Pharmaceuticals Limited  declared its financial results for the quarter ended 30th June 2016. Net sales for the quarter ended 30th June 2016 came in at Rs. 685 crores, recording a growth of 8% as compared to the same prior year period. The sales growth was adversely impacted by the Drug Pricing Control Order (DPCO) revisions in the quarter. Consequently, Profit Before Tax (PBT) at Rs. 111 crores and Profit After Tax (PAT) at Rs 72 crores decline by 23% against the same prior year period.

  • Medigene AG, a clinical stage immune-oncology company focusing on the development of T cell immuno-therapies for the treatment of cancer, announces the grant of US patent US9,341,617B2. The patent, with an expected life-span until 2030, claims a method for the identification of antigens recognized by CD4+ T cells, including tumor infiltrating CD4+ T cells.

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