Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.
Oracle and Exco InTouch announced a partnering agreement that will integrate Exco InTouch’s ePRO patient engagement platform with Oracle Health Sciences’ InForm electronic data capture (EDC) system. The combination of the two platforms is expected to deliver enhanced workflow efficiency in clinical trials. But is the partnership truly a win for both companies?
In May 2014, I interviewed Mithra Bindhu of India-based Asiatic Clinical Research to get an update on performing clinical trials in that country. The DCGI (Drug Controller General of India) had recently attempted to overhaul the entire system, which took a long time, complicated the process of conducting trials in India, and caused some sponsors to question the value of doing business there. Has the situation changed?
The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences
IDRI (Infectious Disease Research Institute), aSeattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I clinical trial for an H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine").
Lorus Therapeutics Inc. (TSX:LOR) ("Lorus"), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced that its Phase I clinical study of LOR-253 has successfully escalated to the target dose level based on predicted and observed clinical effects without limitation by toxicity.
Fab’entech, a French biopharmaceutical company specialized in developing specific polyclonal immunoglobulins against emerging infectious diseases announces that the company is launching its first clinical trial in humans for its product against the H5N1 Avian Influenza virus.
A new clinical research study at Roswell Park Cancer Institute(RPCI) will test a first-of-its-kind cancer “vaccine” that may prove effective against many forms of solid-tumor cancers.
Researchers have launched a clinical trial to evaluate the drug candidate DEX-M74 as a treatment for a rare degenerative muscle disease, hereditary inclusion body myopathy (HIBM). National Institutes of Health scientists from the National Center for Advancing Translational Sciences (NCATS) and the National Human Genome Research Institute (NHGRI) will conduct the clinical trial at the NIH Clinical Center.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs for hard to treat diseases, is pleased to announce that it is in discussions with a major university (the "University") in Europe wishing to conduct clinical trials on Kevetrin™, the Company's flagship anti-cancer compound.
Aeras and the Infectious Disease Research Institute (IDRI) announce today the start of the first clinical trial of IDRI's novel tuberculosis vaccine candidate, ID93 + GLA-SE. The Phase I clinical trial will assess the safety, tolerability and immunogenicity of the vaccine candidate in 60 healthy adult volunteers. The study will be conducted by Johnson County Clin-Trials in Lenexa, Kansas, in close collaboration with Aeras and IDRI.
Lixte Biotechnology Holdings, Inc. (LIXT.PK), announced allowance by the Food and Drug Administration to conduct a Phase I trial of its lead, potentially first-in-class, anti-cancer compound, LB-100. The trial will be conducted at a National Cancer Institute-designated Comprehensive Cancer Center.
The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, has received permission from the Food and Drug Administration to begin a revolutionary Phase 1 clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries.
Merck, known as MSD outside the United States and Canada, announced recently that the company has signed two licensing agreements for investigational HIV drug candidates.
DaVita Clinical Research (DCR), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, has hired four individuals to ignite the expansion of DCR at its latest clinical research facility in Denver, Colo., scheduled to open this month.
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that its SynCon® avian influenza vaccine generated protective HAI titers against six different unmatched strains of H5N1 in a phase I clinical trial - a distinct clinical achievement on Inovio's path to develop universal influenza vaccines.
Dutch vaccine development company Mucosis B.V. today announced Phase I clinical data providing proof-of-concept that Mimopath®-based mucosal vaccines are safe and well tolerated as well as able to produce balanced immune responses in both circulating blood and the respiratory tract.
Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, recently announced that it has submitted a Phase II protocol for the clinical study of Archexin as a treatment of ovarian cancer to the U.S. Food and Drug Administration (FDA).