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.
Montrium recently announced that Illingworth Research Group has selected the Montrium eTMF Connect solution to streamline global clinical operations and centralize collaboration with sponsors and sites.
Precision neuroscience company Cadent Therapeutics has earned a milestone payment from Novartis for the initiation of a Phase 1 clinical study of a subtype selective NMDA receptor negative allosteric modulator (NAM) for the treatment of treatment-resistant depression.
Sanofi and Regeneron Pharmaceuticals, Inc. today announced positive results from a Phase 2 investigational study of dupilumab in adults with active moderate-to-severe eosinophilic esophagitis.
TG Therapeutics (NASDAQ:TGTX) announced today that it has met with the U.S. Food and Drug Administration (FDA) regarding the use of the results from the GENUINE Phase 3 trial to support a Biologics License Application (BLA) filing for approval of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib.
Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on the development of innovative therapeutics for the treatment of Alzheimer’s disease and other neurocognitive disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug CT1812 for the treatment of patients with Alzheimer’s disease
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid system and the bioamine system for the treatment of rare and orphan diseases, announces that three additional patients have been enrolled in the ongoing Phase II COBALT clinical trial of Coversin™ in patients with paroxysmal nocturnal hemoglobinuria (PNH).
OTTR, the leading provider of organ transplant patient tracking software that improves the quality of patient care via workflow management, has partnered with XynManagement, a provider of online solutions to critical problems facing transplant centers.
Eli Lilly and Company (NYSE: LLY) today announced that its Phase 3 JUNIPER study evaluating Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS).
AnaptysBio, Inc. (Nasdaq:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced positive proof-of-concept data for ANB020, its investigational anti-IL-33 therapeutic antibody, in an ongoing Phase 2a clinical trial in adult patients with moderate-to-severe atopic dermatitis.
INC Research/inVentiv Health, the only fully integrated biopharmaceutical solutions organization combining a CRO and CCO (Contract Commercial Organization), recently announced that it was awarded the 2017 Society for Clinical Research Sites (SCRS) Eagle Award in the CRO category during the SCRS Annual Global Site Solutions Summit held October 6-8 in Boca Raton, Florida.
Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene and cell therapies for life-threatening rare diseases, announced one year data from Cohort 1 of the ongoing ABO-102 Phase 1/2 trial for Sanfilippo syndrome Type A (MPS IIIA).
The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations aimed at reducing high rates of turnover among U.S.
Inova Schar Cancer Institute announced today it is recruiting patients for the American Society of Clinical Oncology's (ASCO) first-ever clinical trial, the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.
goBalto, Inc., the leading provider of cloud-based clinical study startup (SSU) solutions, announced today the successful conclusion of its inaugural, invitation only, Pharmaceutical Executive Exchange Roundtable (PEER) event held at The Modern in Manhattan, New York City, one of the city's most prized locations designed to capture the iconic feel of the MoMA.