News Headlines

  1. Adaptimmune Starts The SURPASS Clinical Trial With Its First Next-Generation SPEAR T-cells Targeting MAGE A4 To Enhance Antitumor Responses

    Adaptimmune Therapeutics plc, Philadelphia, PA, and Oxfordshire, UK (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, has initiated SURPASS, its first clinical trial with a next-generation SPEAR T-cell targeting MAGE-A4.

  2. Genkyotex Announces FDA Approval Of Phase 2 Investigator-Initiated Trial With GKT831 In IPF

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX) a biopharmaceutical company and the leader in NOX therapies, announced today that the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application allowing the initiation of a Phase 2 trial of the Company’s lead product candidate, GKT831, in patients with idiopathic pulmonary fibrosis (IPF).

  3. AC Immune Initiates Phase 1 Study Of ACI-3024 Small Molecule Tau Morphomer™, An Investigational Treatment For Alzheimer’s Disease

    AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced dosing of the first subject in a Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ inhibitor that will be studied in neurodegenerative diseases that are characterized by the presence of pathological Tau aggregates.

  4. NuCana Announces First Patients Dosed In Phase I Study Of NUC-7738

    NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, today announced that the first patients have been dosed in the Phase I study of NUC-7738.

  5. OmniComm Systems To Be Acquired By Anju Software

    OmniComm Systems, Inc. (“OmniComm”), a leading strategic software solutions provider to the life sciences industry, announced recently that it has entered into a merger agreement with Anju Software, Inc. (“Anju”). Under the terms of the agreement, OmniComm will become a wholly owned subsidiary of Anju.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.