News Headlines

  1. PHARMASEAL Launches Second Major Release of Engility™ CTMS

    PHARMASEAL, a new provider of clinical trial management and governance solutions to enter the market, announces a second major release of its EngilityTM CTMS platform. Driven by a vision to create smarter technologies and innovative products for the improvement of human health, PHARMASEAL is responding to industry needs with continuous innovation. The result is enhanced capabilities to its enterprise CTMS, including site monitoring, issue management and global access management, simplifying control and operation of clinical trials.

  2. UBC’s Patient & Physician Services (PPS) Creative Services Department Recognized for Excellence in Advertising and Marketing

    UBC was pleased to receive numerous Healthcare Marketing Report’s 36th Annual Healthcare Advertising Awards for their exemplary work.

  3. uniQure Announces 36 Weeks Of Follow-Up Data From Phase IIb Study Of AMT-061 And Long-Term Follow-Up Data For AMT-060 In Patients With Hemophilia B

    uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced updated clinical data on the three patients treated in the Company’s ongoing Phase IIb study of AMT-061, an investigational AAV5-based gene therapy containing a patent-protected FIX-Padua variant for the treatment of patients with severe and moderately severe hemophilia B. In addition, the Company presented up to 3.5 years of follow-up data on the 10 patients in the Phase I/II trial of AMT-060, its first-generation gene therapy for the treatment of hemophilia B.

  4. Global Clinical Trial Disclosure & Transparency Benchmark Survey (2019)

    This questionnaire is designed to develop an annual benchmark across the industry, thereby allowing you to gain insight into other organizations' challenges and priorities, as well as benchmark your capabilities against those of your peers.

  5. Amicus Therapeutics And Catalent Biologics Enter Strategic Partnership For Gene Therapy Development And Manufacturing

    Amicus Therapeutics, Inc. (NASDAQ:FOLD) has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for clinical manufacturing capabilities and capacity for multiple active preclinical lysosomal disorder programs that are currently in development in collaboration with the University of Pennsylvania (Penn).

  6. New Survey Finds Fragmented Processes And System Silos Slowing Clinical Trials

    There is an industrywide drive to streamline trial processes and systems for better study visibility and collaboration, according to the Veeva 2019 Unified Clinical Operations Survey, one of the largest-ever surveys of clinical operations professionals.

  7. ASIT Biotech Continues Its Transformation From Research To Late Stage Clinical Development

    ASIT biotech (ASIT - BE0974289218), a clinical stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, announces that shareholders have approved all motions at the 28th June Extraordinary General Meeting of shareholders.

  8. Spring Bank Submits IND Application For SB 11285, An IV-Administered STING Agonist, For The Treatment Of Advanced Solid Tumors

    Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the company’s intravenously (IV)-administered STimulator of INterferon Gene (STING) agonist development candidate, SB 11285, to initiate a Phase 1 trial with the principal goals of evaluating safety, tolerability and initial anti-tumor activity in patients with advanced solid tumors.

  9. IDDI In Collaboration With Roche Have Identified Why Using Disease Free Survival As A Primary Endpoint In Early Breast Cancer Is The Way Forward

    IDDI’s findings suggest that it is appropriate to use disease-free survival (DFS) as a surrogate for overall survival (OS) in trials in HER-2-positive, early breast cancer.

  10. ContraVir Pharmaceuticals Submits IND Application For CRV431 For NASH

    ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, today announced the filing of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for CRV431 for the treatment of NASH.