News Headlines

  1. Abeona Therapeutics Receives FDA Orphan Drug Designation For EB-101 Gene Therapy Product For Patients With Epidermolysis Bullosa

    Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced today that the FDA has granted Orphan Drug Designation (ODD) for Abeona’s EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa (DEB), including recessive dystrophic epidermolysis  bullosa (RDEB), which are life-threatening genetic skin disorders characterized by skin blisters and erosions that cover the body.

  2. Clinical Leader Forum Success

    The inaugural Clinical Leader Forum concluded in May with successful results. The conference, produced by Life Science Leader and, was designed to gather executives at pharma and biotech sponsor companies who rely on contract research organizations to conduct their clinical trials.

  3. PPD Recognized For Leadership In Clinical Research

    Pharmaceutical Product Development, LLC (PPD) recently announced it has been recognized for excellence in clinical research by pharmaceutical and biotechnology executives surveyed for Life Science Leader magazine’s 2017 CRO Leadership Awards.

  4. TRACON Doses First Patient In Phase 1/2 Study Of TRC253 In Patients With Prostate Cancer

    TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, announced today that the first patient has been dosed in a Phase 1/2 clinical trial of TRC253 in patients with metastatic castration-resistant prostate cancer (mCRPC).

  5. Inovio HIV Vaccine Elicits Nearly 100% Immune Response Rates In A Clinical Study

    Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its HIV vaccine, PENNVAX®-GP, produced amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine.

  6. Clinical Ink And Endpoint Announce Industry-First Alliance

    endpoint Clinical, the leading global interactive response technology (IRT) company, and Clinical Ink, the pioneering provider of eSource and patient engagement technologies, have teamed up to integrate IRT and eSource in order to create a seamless user experience for investigator sites.

  7. Rev Up eCTD Production With Microsystems DocXtools At Drug Information Association Annual Meeting

    Microsystems, a leading provider of document authoring, editing, formatting and quality control solutions for the life science industry, is launching a new and improved version of DocXtools for Life Sciences at the Drug Information Association (DIA) Annual Meeting, June 18–22. DocXtools for Life Sciences dramatically cuts the time required to review electronic common technical documents (eCTD) before submission.

  8. New CTTI Recommendations Provide Path For More Efficient Clinical Trials Using Clinical Registries

    Newly released recommendations from the Clinical Trials Transformation Initiative (CTTI) have the potential to streamline clinical trials by using registry information.

  9. Plazomicin Granted FDA Breakthrough Therapy Designation

    Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for plazomicin, Achaogen’s lead product candidate being developed for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).

  10. Worldwide Clinical Trials Appoints New Vice President Of Clinical Operations, Site Management

    Worldwide Clinical Trials has announced the appointment of Karen Nowatkoski as Vice President of Clinical Operations, Site Management.