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  • 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. 

  • 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. 

  • Chugai Pharmaceutical Co., Ltd.  announced that latest data from an ongoing Japanese phase I/II study (ACE002JP) of emicizumab was presented at the World Federation of Hemophilia 2016 (WFH 2016) World Congress in Orlando, Florida, United States. Emicizumab is a bispecific antibody for subcutaneous injection under development for hemophilia A.

  • 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.

  • Eiger BioPharmaceuticals, Inc., announced that the first patient in the phase 2 ULTRA study was dosed at Stanford University. The ULTRA study will evaluate the effects of ubenimex in patients with secondary lymphedema of the lower limb(s) who are optimized on physical therapies. Physical therapies, such as compression garments and bandaging, reflect the current standard of care for lymphedema. Ubenimex is a well-characterized, oral, small-molecule, inhibitor of leukotriene A4 hydrolase (LTA4H), which blocks the production of leukotriene B4 (LTB4), an inflammatory mediator implicated in lymphedema.

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