Monitoring International Trends posted August 2015



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Contents


1.Products 4

Clotting factors 4

Other 5

2.Regulatory 6



Plasma and recombinant products 6

Other 7


3.Market structure and company news 8

4.Country-specific events 10

 Sonja M. Swenson; Lisa J. Chamberlain, Lee M. Sanders; Vandana Sundaram, Paul H. Wise, “Outpatient Pharmacy Expenditures for Children With Serious Chronic Illness in California, 2010-2012”, published in the Journal of the American Medical Association, 28 July. JAMA. 2015;314(4):405-407. doi:10.1001/jama.2015.7169. 11

5.Safety and patient blood management 11

Appropriate transfusion 11

 Joseph S. Gondusky, Kevin A. Pinkos, Leera Choi, Jay J. Patel, Steven Barnett, Robert S. Gorab, “Simultaneous Bilateral Anterior Approach Total Hip Arthroplasty”,Orthopedics, July 2015-Volume 38 Issue 7: e611-e615. DOI: 10.3928/01477447-20150701-60 12

Treating iron deficiency 12

Other. 13

 Sylvia T. Gunawan, Kristian Kempe, Thomas Bonnard, Jiwei Cui, Karen Alt, Lok S. Law, Xiaowei Wang, Erik Westein, Georgina K. Such, Karlheinz Peter, Christoph E. Hagemeyer, and Frank Caruso, “Multifunctional Thrombin-Activatable Polymer Capsules for Specific Targeting to Activated Platelets”, Advanced Materials, first published online: 3 August 2015. DOI: 10.1002/adma.201502243 13

6.Research 14

 Uli S. Herrmann, Anne K. Schütz, Hamid Shirani, Danzhi Huang,, Dino Saban, Mario Nuvolone, Bei Li, Boris Ballmer, Andreas K. O. Åslund, Jeffrey J. Mason, Elisabeth Rushing, Herbert Budka, Sofie Nyström, Per Hammarström, Anja Böckmann, Amedeo Caflisch, Beat H. Meier, K. Peter R. Nilsson, Simone Hornemann, and Adriano Aguzzi, “Structure-based drug design identifies polythiophenes as antiprion compounds”, Science Translational Medicine 05 Aug 2015: Vol. 7, Issue 299, pp. 299ra123
DOI: 10.1126/scitranslmed.aab1923 16

7.Infectious diseases 16

Mosquito-borne diseases: dengue, malaria and West Nile virus 16

Influenza: strains, spread, prevention and treatment 17


 See the Journal of the American Medical Association (JAMA). Lisa A.Jackson, James D.Campbell, Sharon E.Frey, Kathryn M.Edwards, Wendy A.Keitel, Karen L.Kotloff, Andrea A.Berry, Irene Graham, Robert LAtmar, C. Buddy Creech, Isaac P. Thomsen, Shital M.Patel, Andres F.Gutierrez, Edwin L.Anderson, Hana M.El Sahly, Heather Hill, Diana L.Noah, Abbie R.Bellamy, “Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response:A Randomized Clinical Trial”, doi:10.1001/jama.2015.7916. 18

Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 19

 Lingshu Wang, Wei Shi, M. Gordon Joyce, Kayvon Modjarrad, Yi Zhang, Kwanyee Leung, Christopher R. Lees, Tongqing Zhou, Hadi M. Yassine, Masaru Kanekiyo, Zhi-yong Yang, Xuejun Chen, Michelle M. Becker, Megan Freeman, Leatrice Vogel, Joshua C. Johnson, Gene Olinger, John P. Todd, Ulas Bagci, Jeffrey Solomon et al. “Evaluation of candidate vaccine approaches for MERS-CoV”,Nature Communications 6, article no. 7712. doi:10.1038/ncomms8712 20

Ebola Virus Disease 20

Hendra virus 21




  1. Products


Here the NBA follows the progress in research and clinical trials that may within a reasonable timeframe make new products available, or may lead to new uses or changes in use for existing products.

Clotting factors


    1. Pivotal data for Baxalta’s BAX 855 was published in the journal Blood. The company says the drug has the potential to provide strong bleed prevention in haemophilia A patients with twice weekly dosing. The drug is based on Advate and when approved by the FDA will be marketed in the US as Adynovate. The trial showed a mean half-life extension of 1.4 to 1.5 fold compared with Advate. Baxalta expects to file for marketing authorization with the European Medicines Agency in 2016. A regulatory application was filed in Japan earlier this year.

    2. Baxalta announced the publication1 of pivotal phase III data for BAX 111, a highly purified recombinant von Willebrand factor (rVWF) candidate. The data showed that 100 per cent of the patients treated with BAX 111 achieved success in the management of bleeding episodes2. BAX 111 is currently under review by the US Food and Drug Administration (FDA). If approved, BAX 111 would become the first recombinant replacement treatment for managing bleeding episodes for von Willebrand patients. BAX 111 was developed using a plasma- and albumin-free manufacturing method. Both the FDA and the European Medicines Agency granted orphan drug designation in November 2010, which is reserved for products that meet medical needs for a disease that is classified as rare.

Other


    1. CSL is recruiting 1200 patients for a Phase IIB study of its drug CSL112 for acute coronary syndrome, designed to prevent a second heart attack after a patient has already suffered the first.

    2. A study conducted at the Royal Free Hospital in Kuala Lumpur suggested that patients with gastrointestinal symptoms related to systemic sclerosis may benefit from treatment with intravenous immunoglobulin3

    3. Researchers from Pohang University of Science and Technology reported “a new light-activated, mussel protein-based bio adhesive (LAMBA) inspired by mussel adhesion and insect dityrosine crosslinking chemistry. LAMBA exhibited substantially stronger bulk wet tissue adhesion than commercially available fibrin glue and good biocompatibility in both in vitro and in vivo studies”4. The researchers praised the potential of their product as surgical glue for sutureless wound closures, both internal and external.

    4. Israeli startup LifeBond has developed a firm but elastic hydrogel matrix using a combination of gelatin and microbial transglutaminase (mTG) enzyme. Investors have now made $US 27 million available to fund a US trial of this LifeSeal Surgical Sealant in minimizing postoperative complications such as staple-line leakage in gastro-intestinal and bariatric surgeries. The product has previously undergone a multinational, randomized controlled pilot in Europe and is expected to be granted a CE mark.

    5. Vic Convertino (senior scientist for the US Army Combat Casualty Care Research program at Joint Base San Antonio in Texas) and his fellow researchers say they are nearing approval by the FDA for a small device5 that allows trauma medics to monitor precisely the rate at which a bleeding patient will reach “decompensation,” the point when the body can no longer offset blood loss, shock sets in and death soon follows. Such a device could be of use on the battlefield, where a blood pressure monitor may not indicate much change even when a soldier is losing a significant amount of blood.

  1. Directory: system -> files -> documents
    documents -> Acknowledgements
    documents -> Annual Report 2013
    documents -> Interagency Committee on the Health Effects of Non-ionising Fields: Report to Ministers 2015
    documents -> Final report
    documents -> Foreign Research Reactor West Coast Shipment Spent Nuclear Fuel Transportation Institutional Program External Lessons Learned September 18, 1998 frr snf west Coast Shipment Institutional Program Lesson Learned
    documents -> Report: Shelter Support Mission to Afghanistan
    documents -> Humanitarian Civil-Military Coordination in Emergencies: Towards a Predictable Model
    documents -> Guidance for Public Health Units about the core capacities required at New Zealand international airports under the International Health Regulations (2005) Purpose
    documents -> Rapid Education Needs Assessment Report
    documents -> H Report of a Workshop on Coordinating Regional Capacity Building on Gender Responsive Humanitarian Action in Asia-Pacific

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