The Trickett Wendler Right To Try (RTT) Act was introduced in May 2016 by Sen Ron Johnson (R-Wis). According to Johnson, the bill would ensure terminally ill patients, their doctors, and pharmaceutical manufacturers were allowed to administer investigational treatments where no alternative treatment exists. But for all the fanfare around RTT and the slow federal drug approval process, would the RTT legislation actually help patients?
Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.
Genelux is an oncolytic virus company that was formed in 2001 and has been conducting clinical trials since 2009. The company completed four Phase 1 studies which have enabled it to design what CEO Thomas Zindrick describes as an advanced clinical program.
Clinical news roundup for the week of October 23rd with information on an oncology treatment developed in Cuba, AZ suspending recruitment on two trials, an SCRS white paper on site payments, a new platform for wearables in clinical trials, the CRA shortage, and more.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
Covance was approached by a European client that was considering the acquisition of an early-stage ovarian cancer therapy product.
Oncology is the number one focus of global drug development, accounting for $65 billion in sales worldwide in 2013 and projected to grow 50 percent in the next five years.1 New treatments, new diagnostics and new medical protocols are beginning to unravel some of the scientific basis and pathways of this disease, with measurable impacts on disease progression and quality of life of survivors.
Assessment of ECGs during the development of oncology compounds is challenging. By THIJS van IERSEL, MD, Clinical Pharmacologist and Senior Director, Global Scientific Affairs, PRA Health Sciences; BORJE DARPO, MD, PhD, Chief Scientific Officer, iCardiac Technologies Inc.; GERD AROLD, MD, Senior Director, Global Scientific Affairs, PRA Health Science
Oncologists and their patients have had reason recently to be encouraged by the launch of immune checkpoint inhibitors (ICIs) for the treatment of several difficult-to-treat diseases, including metastatic melanoma and non-small cell lung cancer. These novel agents activate the human immune response against antigens expressed on tumor cells, and the science has generated excitement among physicians, patients, the media and researchers.
The scientific progress being made in cancer research has never been more encouraging or more rewarding. Yet, virtually all oncology drug sponsors face an uphill battle in what one would expect to be the easiest part of the research process: recruiting patients for clinical trials. Despite the seriousness of the diagnosis—or perhaps because of it—only three percent of adult patients with cancer participate in clinical trials. As a result, under-enrollment is common.
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.
The inaugural Clinical Leader Forum concluded in May with successful results. The conference, produced by Life Science Leader and ClinicalLeader.com, was designed to gather executives at pharma and biotech sponsor companies who rely on contract research organizations to conduct their clinical trials.
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.
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).
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.
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.
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.
Newly released recommendations from the Clinical Trials Transformation Initiative (CTTI) have the potential to streamline clinical trials by using registry information.
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).
Worldwide Clinical Trials has announced the appointment of Karen Nowatkoski as Vice President of Clinical Operations, Site Management.
Zealand Pharma ("Zealand") announces positive results from a Phase 2a trial following administration of the multiple-dose version of dasiglucagon in adult patients with type 1 diabetes.
Orbita, Inc., a leading provider of voice-first software for connected home healthcare announced recently a collaboration with ERT to research innovative new approaches to data procurement and management for pharmaceutical and device customers seeking to streamline clinical trials.
CROS NT recently announced the go-live of its RaveX team in an extension of the company’s partnership with Medidata.
TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the independent Data Safety Monitoring Board (DSMB) of the UNITY-CLL Phase 3 trial has successfully completed a pre-specified interim analysis to assess the contribution of TG-1101 (ublituximab) and TGR-1202 in the combination regimen of TG-1101 plus TGR-1202.