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.
Clinical news roundup for the week of October 3, 2016 with information on Biotrial facility in the U.S., clinical trials in Australia, pancreatic cancer research, minority enrollment in trials, and cardiac gene therapy.
Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.
Clinical news roundup for the week of August 8, 2016 with articles on using pets in clinical trials, the Quintiles/DaVita alliance, the benefits and pitfalls of data sharing, and the Orphan Drug Act.
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.
Pharmaceutical Product Development, LLC (PPD) recently announced its launch of a clinical research associates (CRAs) apprenticeship program targeted to military veterans and military service members with medical backgrounds who are transitioning to the civilian workforce.
Medidata, the leading global provider of cloud-based technology and data analytics for clinical research, recently announced that The Leukemia & Lymphoma Society (LLS) has selected the Medidata Clinical Cloud to power its novel trial for acute myeloid leukemia (AML).
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need, announced today that enrollment of Stage 3 in the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has been completed.
To help address the challenges surrounding supply chain management for cell and gene therapy around the globe, Thermo Fisher Scientific, the world leader in serving science, recently announced a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult) to provide developers with both the manufacturing capability and distribution, logistics, and storage capacity needed to create a seamless supply chain to accelerate cell and gene therapy development and commercialsation.
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn’s Disease (the MAP US study).
Minoryx Therapeutics, a drug development company specialized in the discovery of new drugs for orphan diseases, recently announces that it has successfully completed its phase 1 trial with MIN-102.
Leading pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced a second phase 400 percent increase in Cyrogenic storage capabilities at its Rockford, Illinois site.
Neothetics, Inc. (NASDAQ:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market today announced completion of subject enrollment for its Phase 2 proof of concept trial, LIPO-202-CL-31, for the reduction of submental subcutaneous fat.
Sponsors and CROs worldwide have elevated DrugDev to an industry milestone of over $2B in aggregate payments to clinical investigator sites – an accomplishment unequaled by any other provider, including all but the very largest CROs.
Eli Lilly and Company (NYSE: LLY) today announced that its MONARCH 2 trial of abemaciclib met the primary endpoint of progression-free survival (PFS).
DCRI-led study concludes people with atrial fibrillation should not take the drug.
AstraZeneca recently announced results of the first large real-world evidence study of its kind evaluating the risk of hospitalization for heart failure and death from any cause in patients with type-2 diabetes (T2D) receiving treatment with a newer class of diabetes medicines, SGLT-2 inhibitors (SGLT-2i).
A new study is a first step in potentially expanding post-ACS treatment.
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs, today announced the final analysis from the Company’s GALE-301 (E39) investigator-sponsored Phase 1/2a clinical trial.