Wednesday, July 31, 2013
Quanterix, a company focused on high definition diagnostics, has launched its Single Molecule Array (Simoa) technology, making it commercially available for the first time on a fully automated platform for research use only. Simoa enables life science researchers to explore biomarkers and pathways with greater sensitivity and precision, allowing the development of new diagnostic tests and improved treatment of diseases in oncology, neurology and cardiology.
AstraZeneca and biotechnology company FibroGen have entered into a collaboration to develop and commercialize FG-4592, a first-in-class oral compound in late stage development for the treatment of anemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD), which also may be extended to other anemia indications.
Array BioPharma will collaborate with New Jersey-based biopharmaceutical company Celgene for an Array-invented preclinical development program targeting a novel inflammation pathway. Array will receive an up-front payment of $11 million and Celgene will have an exclusive option to license multiple clinical development candidates. Array is entitled to receive potential milestone payments of up to $376 million based upon achieving certain development, regulatory and sales objectives. Array is also entitled to receive royalties on net sales of all drugs and will retain all rights to the program if Celgene does not exercise its option.
StemCells has launched its Alzheimer’s disease program, supported by the California Institute for Regenerative Medicine (CIRM). The goal is to file, within four years, an IND application with the FDA to evaluate the company’s proprietary HuCNS-SC product candidate (purified human neural stem cells) as a potential therapeutic in the treatment of Alzheimer’s disease.
Medistem, developer of Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product, will collaborate with Reza Abdi, M.D., transplant nephrologist at Brigham and Women’s Hospital and assistant professor of medicine, Harvard Medical School. The company will provide Abdi with its ERCs and it is expected that his research would support FDA clearance to initiate clinical trials to use ERCs as a treatment for type 1 diabetes. The company has FDA clearance to initiate a dose-escalating phase I clinical trial to use ERCs in patients with critical limb ischemia, a complication of diabetes.
Raleigh, N.C.-based INC Research, a therapeutically focused global CRO, has established INC Research Japan KK, with the opening of locations in Osaka and the Shinagawa ward in Tokyo. The new operations provide INC Research’s global drug development customers access to an increasingly significant market and further expand its presence in the Asia-Pacific region.
CRO Covance said its central laboratory services once again ranked first in an independent global survey of physician investigators in clinical trials. Of the study participants, 47% named Covance’s central lab services as their “most preferred” central lab, with investigators citing Covance more than twice as often as the nearest competitor. Investigators also reported having the “best overall relationship” with Covance, rating it 8.4 on a scale of 1 to 10.