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The Medical Research Council (MRC) has published a review of the U.K.’s capabilities in molecular pathology—the discipline that uses analysis of the molecules within tissue and body fluids to aid in a more accurate diagnosis and monitoring of disease. The review identifies three areas which, if not addressed, could inhibit the discovery, development and adoption of innovative diagnostic tests that will ultimately offer clinical, economic and research benefits.
ViaCyte, a San Diego-based, privately held regenerative medicine company, has entered into a $20 million rights agreement with Janssen R&D, a unit of Johnson & Johnson. The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01 combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01.
Among the five pharmaceutical markets of Brazil, India, Mexico, Singapore and Thailand, Brazil and Mexico are projected to be the leading contributors to the dengue vaccine marketplace, as it expands rapidly from an estimated $70 million in 2015 to $400 million by 2020, at a Compound Annual Growth Rate (CAGR) of 42%, according to U.K. research and consulting firm GlobalData.
Emergent BioSolutions, a Rockville, Md.-based global specialty biopharmaceutical company, and MorphoSys, a Germany-based provider of therapeutic antibodies, have inked an agreement for the joint development and commercialization of Emergent’s preclinical bi-specific antibody, ES414, targeting prostate cancer. Emergent will receive an upfront payment of $20 million and milestone payments of up to $163 million.
Novartis has signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance), which has locations in the U.S., Brussels and South Africa, for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).
AstraZeneca and Mitsubishi Tanabe Pharma Corporation (MTPC), a research-driven pharmaceutical company based in Japan, have announced a three-year research collaboration in diabetic nephropathy. The aim is to leverage complementary strengths, expertise and assets to validate and progress novel research targets and molecules into clinical development.
Bristol-Myers Squibb and Celgene have established a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of BMS’ investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and Celgene’s nab technology-based chemotherapy Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in a phase I study.
Illumina, a California-based developer, manufacturer and marketer of life science tools and integrated systems for the analysis of genetic variation and function, has formed collaborative partnerships with AstraZeneca, Janssen Biotech and Sanofi to develop a universal next-generation sequencing (NGS)-based oncology test system.
The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted (10 yes, three no) t/news-online/company/Boehringer+Ingelheimhat existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.
Amgen has announced that a second placebo-controlled, phase III study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints.
Clintrax Global, a worldwide provider of clinical research services located in Raleigh, N.C., recently announced the addition of Bradford Evans as vice president of administration. Evans will oversee all corporate processes, including their alignment with company objectives and policies.
MediciGlobal, a global provider of patient recruitment and retention for clinical trials with offices in Pennsylvania and London, has appointed Linda Capsey, Ph.D., vice president project management and innovation. Capsey will provide strategic and operational oversight for recruitment-retention program development, site training workshops for patient communications and informed consent, and work as a consultant to biopharmaceutical companies for patient recruitment-retention planning and feasibility.
Bedrocan Cannabis, previously Bedrocan Canada has appointed three independent members to its board of directors, enhancing executive oversight and strengthening the health care experience of the company, a licensed researcher and producer of medicinal cannabis in Canada.
Gamida Cell, an Israel-based provider of stem cell expansion technologies and therapeutic products, has signed an investment and option agreement with Novartis Pharma. Novartis will invest $35 million in Gamida Cell and in return will receive 15% equity and an option to fully acquire Gamida Cell. The option is exercisable for a limited period of time following achievement of certain milestones connected to the development of NiCord, anticipated to be met during 2015.
Cytori Therapeutics, a California-based developer of cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions, and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, have announced the execution of a contract option to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries.
Researchers at RTI International, a nonprofit organization headquartered in Research Triangle Park, N.C., that provides research and technical services, in collaboration with the University of North Carolina at Chapel Hill, have developed a new lung-on-chip microdevice for laboratory studies of respiratory challenges and therapeutics. The microdevice includes multiple vertically stacked cellular layers that mimic the structure of the airway tissue.
Valeant Pharmaceuticals International has extended the expiration of its exchange offer to acquire all outstanding shares of Allergan to 5:00 p.m., New York City time, Dec. 31. The exchange offer previously was scheduled to expire at 5:00 p.m., New York City time, Friday, Aug. 15. All other terms and conditions of the exchange offer remain unchanged.
MMS Holdings, a Mississippi-based global CRO that focuses on regulatory submission support, and Oncology Trials Insights (OTI), a Colorado-based organization of oncology key opinion leaders that architect superior clinical trial strategies and facilitate improved decision-making, have partnered to deliver comprehensive oncology support services.
Roche and the Australia-based Garvan Institute of Medical Research are collaborating to develop new technologies for targeted epigenomic analysis using DNA sequencing. Genomics is a rapidly evolving field with a focus on realizing the potential use of sequencing information in patient diagnosis and treatment.
The Singapore-based Agency for Science, Technology and Research (A*STAR) and Japan-based Sumitomo Mitsui Banking Corporation (SMBC) have inked a memorandum of understanding (MOU), with the aim of supporting Japanese R&D activities in Singapore for the next three years.