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Search Results - Regulatory
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  • Multitasking Multiplex Assays
    drug development companies, regulatory agencies and payers-must work together. ... Regulatory Issues Illumina's MiSeqDx Cystic Fibrosis System has been submitted for FDA ...
    10-15-2013
  • Growing and Preparing Adult Stem Cells
    These factors include breakthroughs in reprogramming, ethical and regulatory issues more ... Sackner-Bernstein, M.D., vp for clinical development and regulatory affairs at NeoStem. ...
    10-15-2013
  • Antisense Drugs Finally Turning the Corner
    ... is supported by development, regulatory, and IP incentives, which makes it ... sIGF-I normalization is also the endpoint for regulatory approval of acromegaly therapies. ...
    10-15-2013
  • Auxilium Licenses Stendra from Vivus for Up to $300M
    Vivus retains commercial rights to Stendra outside the United States and Canada, while continuing to oversee product's development and regulatory approval in the United States. ...
    10-11-2013
  • Yale Launches Collaboration with ARO, CRO Partners
    other, co-facilitation of liaison with regulatory and governmental bodies and ... sharing and subcontracting monitoring, regulatory, safety, core laboratory, data ...
    10-11-2013
  • Teva Cutting 5,000 Jobs in Global Restructuring
    In June, Teva acquired MicroDose Therapeutx for $165 million-plus-including $40 million up front, up to $125 million tied to undisclosed regulatory and development milestones, plus ...
    10-10-2013
  • Active Biotech and Hutchison China MediTech Get Rewarded
    Tasquinimod is a small molecule that targets the tumor microenvironment by binding to S100A9 and modulating regulatory myeloid cell functions. The milestone was earmarked for the ...
    10-9-2013
  • Clinical Genomics Nabs Enterix, Aims to Launch New Bowel Cancer...
    in Australia in early 2014. With this acquisition, Clinical Genomics is receiving a regulatory-licensed manufacturing facility in the U.S. and Australia, as well as access to a ...
    10-8-2013
  • J&J's Janssen Buys Rights to Hepatitis C Compound from GSK
    Simeprevir was approved in Japan last month and has been submitted for regulatory approval in the United States, Canada, and Europe. Simeprevir remains in Phase II studies in ...
    10-8-2013
  • Ovarian Cancer Treatment Options Multiply
    ... CGEN-15049 is expressed on many cancers and inhibits the immune response of many immune cells. In vitro studies show it inhibits natural killer cells and modulates regulatory T ...
    10-8-2013
  • J&J's Janssen Companies Launch a Trio of Collaborations
    designed to promote immune tolerance by blocking CD28 signaling within the T-cell signaling pathway, thus preventing the functioning of effector T cells but not regulatory T cells. ...
    10-3-2013
  • Lilly Peers Into Future, Sees Three Drug Launches in 2014
    can be launched in 2014, having made regulatory submissions in the United States and ... These drugs, according to Lilly, "could form the basis for a regulatory submission as ...
    10-3-2013
  • Acino Supports Acquisition by Private Equity Firms
    acceptance by holders of two-thirds (66.67%) of Acino's shares, as well as other customary conditions and regulatory approvals. As part of the deal, Håkan Björklund, M.D., Ph . ...
    10-2-2013
  • Young Companies in the Money: 25 Firms to Watch
    ... July 9 Purpose: Commercialization of Glybera, the first gene therapy to receive regulatory approval in Europe, as well as the co-development of a gene therapy for hemophilia ...
    10-2-2013
  • Merck & Co. Axes 8,500 in R&D Restructuring
    when fully implemented in 2015 - and, it hopes, end a long period of setbacks in which numerous pipeline drugs have failed to win regulatory approvals or failed in clinical trials. ...
    10-1-2013
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    Journal Articles

  • Regulatory T Cell Frequencies Do Not Correlate with Breadth or...
    Mathieu Angin, Hendrik Streeck, Fang Wen, Melanie King, Florencia Pereyra, Marcus Altfeld, Bruce D. Walker, Marylyn M. Addo
    AIDS Research and Human Retroviruses
    Regulatory T Cell Frequencies Do Not Correlate with Breadth or Magnitude of HIV-1-Specific T Cell Responses AIDS Research and Human Retroviruses Regulatory T cells (Tregs) are ...
  • Regulatory Management and Communication of Risk Associated with...
    Charles Dodd, Douglas Powell
    Foodborne Pathogens and Disease
    Regulatory Management and Communication of Risk Associated with Escherichia coli O157:H7 ... may hamper stakeholder perception of regulatory efforts in the face of continued E. ...
  • Regulatory and Ethical Issues for Phase I In Utero Gene Transfer...
    Carson Strong
    Human Gene Therapy and Part B: Methods
    Regulatory and Ethical Issues for Phase I In Utero Gene Transfer Studies Human Gene ... The prospect of human phase I in utero gene transfer studies raises important regulatory ...
  • Regulatory Considerations for Novel Gene Therapy Products: A...
    Carl H. June, Boro Dropulic, Peter Manilla, Tessio Rebello, Cathleen Afable, Xiaobin Lu, Vladimir Slepushkin, Laurent M. Humeau, Kathy Schonely, Yajin Ni, Gwendolyn K. Binder, Bruce L. Levine, Rob-Roy Macgregor
    Human Gene Therapy and Part B: Methods
    Regulatory Considerations for Novel Gene Therapy Products: A Review of the Process Leading ... to be addressed during the regulatory review process before initiating the clinical trial. ...

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