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.
Shire plc (LSE: SHP, NASDAQ: SHPG), Microsoft and EURORDIS-Rare Diseases Europe today announced a strategic alliance to address the diagnostic challenge for patients living with a rare disease. The long road to diagnosis is one of the most important issues affecting the health, longevity and well-being for rare disease patients and their families.
Wave Life Sciences Ltd. a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, recently announced the formation of a global strategic collaboration with Takeda Pharmaceutical Company Limited to discover, develop and commercialize nucleic acid therapies for disorders of the central nervous system (CNS).
Applied Therapeutics Inc., a privately-held biotechnology company focused on developing transformative drugs in areas of high unmet medical need, recently announced initiation of a Phase 1 clinical trial for AT-001, an oral small molecule in development for diabetic complications.
Celgene’s recent announcement of the acquisition of Juno Therapeutics has put the company in a good position to be a frontrunner in the chimeric antigen receptor- T cell (CAR-T) space.
Abeona Therapeutics Inc, a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced recently that the FDA has granted Orphan Drug Designation (ODD) to its ABO-202 program (AAV-CLN1), an AAV-based gene therapy for the treatment of infantile Batten disease.
Bracket, a leading clinical trial technology and specialty services provider, recently announced the appointment of Michael P. Nolte as Chief Executive Officer.
Amicus Therapeutics (Nasdaq:FOLD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for filing under priority review for the oral precision medicine migalastat HCl ("migalastat") for the treatment of patients 16 years and older with Fabry disease who have amenable mutations.
Recently, after an 18-month long campaign by JDRF and its supporters across the country, Congress approved legislation for a two-year extension of the Special Diabetes Program (SDP), providing $300M for type 1 diabetes (T1D) research through the National Institutes of Health.
Analysis of 3,199 clinical trials in Australia from 2012 to 2016 found that Phase III trials outnumbered all other trials overall, making up 33–41% of the trial types during the period, according to GlobalData, a leading data and analytics company.
ChromaDex Corp. (NASDAQ:CDXC), an integrated, science-based, nutraceutical company devoted to improving the way people age, announced today that the results from its collaborative research agreement with the NIA and NIH which appear in the Feb. 5, 2018, issue of Proceedings of the National Academy of Sciences (PNAS) and were announced in an NIH news release, show that NIAGEN® nicotinamide riboside (NR) prevented neurological damage and improved cognitive and physical function in a new mouse model of Alzheimer’s disease (AD) that more closely resembles human AD than other mouse models.
Syneos Health (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, has announced the appointment of Lisa van Capelle as Chief Human Resources Officer (CHRO).
ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, recently announced advanced respiratory clinical trial services that centrally collect lung function data using the Forced Oscillation Technique (FOT).
Immutep Limited (ASX:IMM) (NASDAQ:IMMP) (“Immutep” or the “Company”), announced today that the Database Safety Monitoring Board (“DSMB”) confirmed that the combination of eftilagimod alpha (“efti”, “LAG-3Ig”, or “IMP321”) with pembrolizumab (KEYTRUDA) is safe and well tolerated at doses up to 30 mg per subcutaneous injection.
Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, today announced updated clinical data from the ongoing Phase 1/2 trial for ABO-102 (AAV-SGSH), the company’s investigational gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA), a rare autosomal-recessive lysosomal storage disease.