• Seattle Genetics Ends Clinical Trial Of Leukemia Drug After A Higher Rate Of Deaths

    The Seattle Times |  Seattle Genetics said it is discontinuing a Phase 3 clinical trial after data showed "a higher rate of deaths, including fatal infections" in acute myeloid leukemia patients receiving its drug than in the study's other patients.

    Jun 19, 2017

  • Fostering Medical Innovation A Plan for Digital Health Devices

    FDA Voice |  Scott Gottlieb introduces a new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how we intend to regulate these digital medical devices.

    Jun 15, 2017

  • It’s About Time: Proactive Vs. Reactive

    Clinical Informatics News | It’s About Time | Norman Goldfarb speaks with Reg Blynn, Vice President of Client Services at QuintilesIMS, about the need for clinical sites to be more proactive in the areas of business development, patient recruitment, and quality.

    Jun 15, 2017

  • FDA Used Real-World Evidence In Heart Valve Approval

    RAPS |  The US Food and Drug Administration says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement to valve-in-valve procedures.

    Jun 14, 2017

  • Controversial Trial Of Premature Infants Facing Fresh Scrutiny

    STAT |  Watchdog group argues that newly released documents show researchers continued an experiment despite learning their oxygen monitors were malfunctioning.

    Jun 14, 2017

  • The Future Of Strategic Partnerships Between CROs And Sponsors: A Necessary Evolution For A Better Cause?

    Clinical Informatics News Contributed Commentary | Outsourcing strategy in the drug development sector is notoriously cyclical. Companies move between using in-house teams, project-based outsourcing, functional outsourcing, and strategic partnerships in response to the changing global business climate. The requirement to adapt is not unique to trial sponsors and we should not be surprised that strategic business models need to change as well.

    Jun 14, 2017

  • Why Doctors Hate Electronic Records — And What Could Change That

    San Francisco Chronicle |  The health care industrial complex has spent billions of dollars and untold amounts of time trying to make medical records as flexible, invisible and unobtrusive as possible for patients and clinicians alike. The results will be well worth the expense if the records could help clinicians spend more time caring for people and less on paperwork.

    Jun 13, 2017

  • iSpecimen Launches Biospecimen Marketplace

    Clinical Informatics News | iSpecimen launched its marketplace today, an online shopping platform to connect life science researchers to healthcare organizations with human biospecimens.

    Jun 13, 2017

  • Trump Names Sharpless To Lead U.S. Cancer Institute

    Science |  President Donald Trump announced his intention to appoint Norman Sharpless to be the next director of the National Cancer Institute.

    Jun 12, 2017

  • Consented Cohorts Powering Observational Studies

    Clinical Informatics News | Novaseek’s Clinical Data Network for Research provides researchers with well-categorized cohorts of consented patients while allowing hospitals and physician groups to share their data and samples with researchers.

    Jun 9, 2017

  • Revisiting What Went Wrong In The Clinical Trial Tragedy In France

    Chemical & Engineering News |  In January 2016, one clinical trial volunteer in France died, four others were hospitalized, and two of those went on to have long-term neurological damage. Attempting to provide answers to what went wrong, a study published in Science now reports that the drug candidate responsible for the tragedy, BIA 10-2474, covalently binds several enzymes in addition to the fatty acid amide hydrolase (FAAH) it was designed to block.

    Jun 8, 2017

  • Polio Outbreak Is Reported In Syria, Health Officials Say

    STAT |  The new cases are vaccine-derived polioviruses and not an indication the viruses are spreading "in the wild," according to the WHO.

    Jun 8, 2017

  • Trump Announces He Will Keep Francis Collins As NIH Director

    STAT |  Dr. Francis Collins, a holdover from the Obama administration, will remain director of the National Institutes of Health, the White House announced.

    Jun 7, 2017