Keystone Nano, a small oncology-focused company in State College, PA, recently received an IND approval from the FDA and launched its first clinical trial. While that transition from discovery to clinical is an exciting time for most companies, it is also a time of greater challenges as your product is used in humans for the first time. Jeff Davidson, CEO of Keystone Nano, has learned about many of these challenges first-hand.
Clinical news roundup for the week of May 14, 2017 with information on a new head of the FDA, inVentiv Health and INC Research merging, helping patients navigate cancer clinical trials, new standards for trial results, and more.
Samus Therapeutics is a privately-held, biopharmaceutical company focused on developing novel therapeutics and diagnostics targeting the epichaperome, a foundational protein complex emergent from multiple disease states, including oncology and neurology. “We are the ‘anti-epichaperome company,’ says Jonathan Lewis, the company’s executive chairman and CEO. “Following various forms of cellular stress, chaperome units are rewired into the epichaperome network. Targeting and disrupting the epichaperome in cancer results in cell death and in neurologic diseases, neuronal survival, with no apparent effect on normal cells.”
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.
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.
Esperion (NASDAQ:ESPR), the Lipid Management Company focused on developing and commercializing complementary, convenient, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced positive top-line results from the third of five pivotal Phase 3 studies (Study 3 or 1002-046) expected to be reported this year.
INmune Bio, Inc., an immunotherapy company developing therapies that reprogram the patient’s innate immune system to treat cancer, today announced that it has initiated a Phase 1 clinical trial of its drug candidate INB03™ in patients with advanced solid tumors.
Bionomics Limited, a global, clinical stage biopharmaceutical company, recently announces that a Phase 2 clinical trial of its therapeutic candidate, BNC210, has commenced in elderly patients with agitation in the hospital setting. The first participant has been recruited into the trial.
WCG™ (WIRB-Copernicus Group®) Clinical Services Division, the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, recently announced the opening of the company’s new office in Tokyo, Japan.
Nabriva Therapeutics plc (NASDAQ:NBRV) today announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, the second of two global, pivotal Phase 3 clinical trials of lefamulin.
MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics and targeted therapies for cancer treatment, today announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM).
Beta Bionics, Inc. – a medical technology company leveraging machine learning artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas – today announced that it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D).
uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, presented data showing successful liver transduction with the AAV5 vector in both non-human primates and humans with pre-existing anti-AAV5 neutralizing antibodies (NABs).
CRF Health, a leading global provider of patient-centered eSource technology solutions for the life sciences industry, recently announced that the company has been recognized as 2018 New Entrant of the Year in Romania’s Regional IT & Outsourcing Industry Awards, (also known as the PIN Awards).
Oral insulin, the Holy Grail of diabetes care that has alluded researchers for decades, is taking a major step towards becoming reality.
Clinical research organisations (CRO) and sponsors who sign up for ClinicalStudio.EU will be able to use a blockchain to launch Smartillions smart contracts to manage their Horizon 2020 R&D grant applications and compliance with GDPR, MDR and international clinical trial regulations.
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, recently announced it has completed the second phase of a $5.5M expansion program at its Kansas City, Missouri facility, to increase the controlled-substance and controlled-temperature storage capabilities for its clinical supply business.
Greenphire, the global leader in financial software for clinical trials, recently released key findings from meetings with nearly a dozen Clinical Research Organizations (CROs) from its Site Payment Advisory Group on the topic of investigator payment processes.
A pivotal Phase 3 trial evaluating Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (ages 12-17) met its primary and key secondary endpoints.