ARIAD and STA Announce Approval of Iclusig (Ponatinib) in Australia

CAMBRIDGE, Mass. & Melbourne, Australia -- ARIAD Pharmaceuticals, Inc. (ARIA) and Specialised Therapeutics Australia Pty Ltd (STA), today announced the marketing approval of IclusigTM (ponatinib) in Australia by the Therapeutic Goods Administration (TGA).

The Australian Product Information for Iclusig states that it is indicated for the treatment of adult patients with:

  • Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a T315I mutation.
  • Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a T3151 mutation.
Published: 24 November 2014
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Bristol-Myers Squibb and Five Prime Therapeutics Announce Exclusive Clinical Collaboration to Evaluate the Combination of Investigational Immunotherapies Opdivo (nivolumab) and FPA008 in Six Tumor Types

NEW YORK and SOUTH SAN FRANCISCO, Calif., Nov. 24, 2014 -- Bristol-Myers Squibb Company (BMY) and Five Prime Therapeutics, Inc. (FPRX) today announced that they have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo (nivolumab), Bristol-Myers Squibb's investigational PD-1 (programmed death-1) immune checkpoint inhibitor, with FPA008, Five Prime's monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R). The Phase 1a/1b study will evaluate the combination of Opdivo and FPA008 as a potential treatment option for patients with non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.

Published: 24 November 2014
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BioMarin and Prosensa Holding N.V. Reach Agreement on Intended Public Offer for 100% of Prosensa's Outstanding Stock; Will Add Duchenne Muscular Dystrophy Products to Rare-Disease Portfolio

  • Acquisition of Prosensa provides near-term opportunity to commercialize, if approved, its exon-skipping drug candidate,drisapersen, for Duchenne muscular dystrophy (DMD)
  • Drisapersen is currently under a rolling review as part of a New Drug Application process and has Orphan, Fast Track and Breakthrough Therapy designation by the FDA
  • Drisapersen, a potential first-to-market and best-in-class product for treating a large population of patients with a rare, fatal genetic disease represents up to 10,000 DMD patients
  • Follow-on products leveraging Prosensa's same technology platform in the pipeline target an additional 35,000 DMD patients in BioMarin's commercial territories
  • Investor conference call to be held today, November 24, 2014 at 5am PST (8am EST)
Published: 24 November 2014
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ZS Pharma Announces Publication of Results From Phase 3 Study of ZS-9 in Patients With Hyperkalemia in the New England Journal of Medicine

ZS-9 Normalizes 98 Percent of Patients Within 48 Hours and a High Proportion of Patients Who Continued on ZS-9 Maintained Normokalemia

COPPELL, Texas, Nov. 21, 2014 -- ZS Pharma (ZSPH), a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced the publication of previously unreleased detailed results from the ZS003 study in the New England Journal of Medicine (NEJM). ZS003 was a Phase 3, 753 patient, multicenter, randomized, double-blind, placebo-controlled trial that assessed the safety and efficacy of ZS-9 (sodium zirconium cyclosilicate) in treating patients with hyperkalemia, a life threatening condition characterized by abnormally high concentrations of potassium in the blood (serum K+ >=5.1 mEq/L).

Published: 21 November 2014
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Can-Fite Near-Term Milestones Timetable for 2014/2015

PETACH TIKVA, Israel, Nov. 18, 2014  -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced several upcoming and near-term milestones on its CF101 and CF102 indications for liver cancer, rheumatoid arthritis, psoriasis, glaucoma and the development of a commercial biomarker blood test kit for the A3 adenosine receptor (A3AR).

The Company believes that it is on the cusp of reaching several significant milestones in its studies, with respect to CF102 for the treatment liver cancer and CF101 with respect  to the treatment of rheumatoid arthritis, psoriasis and glaucoma. The below near-term key events provide an outlook of Can-Fite's objectives and potential for increased growth.  

Published: 18 November 2014
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