News Headlines

  1. eClinical Data Volume And Diversity Pose Increasing Challenges And Delays, According To The Tufts Center For The Study Of Drug Development

    The growing volume of data collected in clinical trials is contributing to longer development times and posing technical and integration challenges to clinical data management staff, according to a recently completed analysis by the Tufts Center for the Study of Drug Development.

  2. Sanofi And Alnylam Enter Into Strategic Restructuring Of RNAi Therapeutics Rare Disease Alliance

    Sanofi and Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases.

  3. Akcea Initiates Phase 2b Study Of AKCEA-APOCIII-LRx In Patients With Hypertriglyceridemia And Established Cardiovascular Disease

    Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, today announced the initiation of a Phase 2b clinical study of AKCEA-APOCIII-LRx in patients with hypertriglyceridemia and established cardiovascular disease (CVD).

  4. Inspire And Antidote Launch End-To-End Clinical Trial Recruitment Solution To Accelerate Medical Research

    Inspire, the leading healthcare social network, and Antidote, a digital health company that connects patients with research, announced a strategic collaboration today that will provide an unparalleled end-to-end patient recruitment model to pharmaceutical companies and CROs.

  5. INC Research/Inventiv Health Becomes Syneos Health™

    INC Research/inVentiv Health recently announced it has changed its brand identity to Syneos Health, Inc., effective January 4, 2018. More than 21,000 of the top minds in clinical and commercial development are now united under this singular brand, signifying the culmination of a thoughtful merger combining industry-leading Contract Research Organization (CRO) and Contract Commercial Organization (CCO) capabilities.

  6. Greenovation Biotech GmbH Reports Positive Clinical Data From The Phase 1 Safety Study For Moss-aGal

    In October, Greenovation Biotech GmbH successfully completed the Phase I study of moss-aGal for the treatment of Fabry disease (FD). The results of the study indicate that moss-aGal has an excellent safety profile at the tested dose of 0.2 mg / kg body weight.

  7. Achillion Initiates Phase I First-In Study Of ACH-5228, A Next-Generation Oral Small Molecule Inhibitor Of Complement Factor D

    Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a pharmaceutical company focused on advancing small molecule inhibitors of factor D in the complement alternative pathway, today announced that the Company has begun dosing subjects in a first-in-human phase 1 trial of ACH-5228, a next-generation, oral small-molecule factor D inhibitor.

  8. CTTI Selected To Support FDA Efforts To Increase Patient Engagement Through New Collaborative

    Recently the Clinical Trials Transformation Initiative (CTTI) is announcing it has been engaged by the U.S. Food and Drug Administration (FDA) to support its Patient Engagement Collaborative (PEC), an effort created in partnership with CTTI to bring together members of the patient community to discuss the best ways for patients to participate in the FDA’s regulatory discussions about medical products.

  9. TARIS And Bristol-Myers Squibb Announce Clinical Trial Collaboration

    TARIS Biomedical LLC, and Bristol-Myers Squibb recently announced that the companies have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS™), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab).

  10. A More Modern ResearchKit Alternative For Study Developers

    In 2015 Apple launched ResearchKit® - a powerful tool to deploy clinical research in a mobile world. Up until about six months ago, Apple’s ResearchKit was the only sound and high tech option if you wanted to conduct clinical research in a strictly native mobile environment.