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  • PDA/FDA Joint Regulatory Conference
    Washington DC UNITED STATES www.pda.org/pdafda2013
    9-16-2013
  • Sanofi Presents Encouraging Phase III Data for Myelofibrosis...
    the completion of pivotal Phase III studies in less than three years, and now we are planning regulatory filings with authorities to make this medicine available for patients," Dr. ...
    5-17-2013
  • AbbVie Expands Galapagos Collaboration to Include Crohn's Disease
    development beyond Phase II, including regulatory and commercialization activities. ... to achieving undisclosed developmental, regulatory, commercial, and sales-based ...
    5-17-2013
  • RuiYi Licenses mAb Development to China's Genor
    "The team at Genor has deep global development experience and strong commercial, regulatory, and government relationships in China, making them the ideal development partner," ...
    5-16-2013
  • Pharma Touting Phase II/III Wins in Run-Up to ASCO
    ... In a statement, Mathias Knecht, vp of Medical and Regulatory Affairs, said his firm's "positive study results support why it's important to explore tailored treatment options." ...
    5-16-2013
  • Inside Story Behind Glybera's Development and Approval
    downs and ins and outs of not only developing the new therapeutic but also gaining regulatory approval for the novel product. JMW is an inventor on the AAV1 patent and will ...
    5-15-2013
  • Seasoned Drugs Offer Therapeutic Gold Mine
    ... In contrast, his approach relies on a mechanistic interpretation, including molecular pathways or gene regulatory networks, as to a particular drug's newfound effectiveness against ...
    5-15-2013
  • Highlights from AACR
    ... tools for studying regulatory elements in the human genome, including reporter assays. ... expression to generate hypothetical regulatory networks that may have a role in a ...
    5-15-2013
  • RuiYi, CMC Collaborate to Speed mAb Development
    for additional undisclosed amount of payments tied to achievement of clinical, regulatory, and commercialization milestones, as well as royalties based on worldwide net sales ...
    5-14-2013
  • Layoffs Imminent at Astellas: Two U.S. Labs to Close
    By April 2014, Astellas plans to consolidate its Clinical Development, Quality Assurance & Regulatory Affairs, and Pharmacovigilance functions by moving them from Itabashi-ku, ...
    5-14-2013
  • Vectura, Chinese Partners Form $65M Respiratory JV
    technology with KingYork's local regulatory expertise and experience in ... Assets include manufacturing equipment, formulation know-how, and the regulatory dossiers ...
    5-13-2013
  • Biogen Idec Pays Isis $3.5M for Antisense Drug Milestone
    completion of the first successful Phase II/III study), Isis could earn another $255 million in license fees and regulatory milestone payments plus double-digit sales royalties. ...
    5-10-2013
  • Companion Diagnostics: 52 Pick-Up
    ... In Japan, diagnostic has received regulatory approval. Financial terms: Not disclosed. ... tied to specified but undisclosed development, regulatory, and commercialization goals. ...
    5-9-2013
  • Cancer Diagnostics, Pushing the Boundaries
    ... in which the PTEN gene may be present and unadulterated but epigenetic changes to the regulatory DNA upstream of the gene block expression, resulting in loss of the PTEN protein. ...
    5-8-2013
  • Celgene, Concert in $300M+ Deuterium Drug Collaboration
    And if Celgene exercises its options and agrees to develop DCE-based drugs, Concert will be eligible for more than $300 million in payments tied to development, regulatory, and ...
    5-6-2013
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    Journal Articles

  • Analysis of CD4 + CD25 + Foxp3 + Regulatory T Cells in HIV-Exposed...
    Lin Li, Yongjian Liu, Zuoyi Bao, Lili Chen, Zheng Wang, Tianyi Li, Hanping Li, Daomin Zhuang, Siyang Liu, Xiaolin Wang, Jingyun Li
    Viral Immunology
    Analysis of CD4 + CD25 + Foxp3 + Regulatory T Cells in HIV-Exposed Seronegative Persons and HIV-Infected Persons with Different Disease Progressions Viral Immunology Regulatory T ...
  • Noninvasive Imaging of Bone-Specific Collagen I Expression in...
    Jun Liu, Roel Arends, Anton Martens, Maria H.C. den Brok-Bardoel, Marian G.H. Scheepers, Clemens A. van Blitterswijk, Jan de Boer
    Tissue Engineering, Part C: Methods
    The aim of this study was to validate the Col(I)-Luc transgenic mouse model in which the luciferase gene is driven by bone-specific regulatory elements from the mouse collagen ...
  • Cell-Seeding Techniques in Vascular Tissue Engineering
    Gustavo A. Villalona, Brooks Udelsman, Daniel R. Duncan, Edward McGillicuddy, Rajendra F. Sawh-Martinez, Narutoshi Hibino, Christopher Painter, Tamar Mirensky, Benjamin Erickson, Toshiharu Shinoka, Christopher K. Breuer
    Tissue Engineering, Part B: Reviews
    to consider the regulatory issues surrounding the translation of these technologies. ... and special emphasis placed on regulatory issues concerning the clinical ...
  • Bone Tissue Engineering and Regeneration: From Discovery to the...
    Regis J. O'Keefe, Jeremy Mao
    Tissue Engineering, Part B: Reviews
    complex structure and functions and requires exquisite interactions between cells, matrices, biomechanical forces, and gene and protein regulatory factors for sustained function. ...

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