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Neurocrine Biosciences has announced that NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist, has entered clinical trials for the treatment of classic congenital adrenal hyperplasia (CAH) a disease that affects approximately 20,000-30,000 people in the U.S. The company has successfully completed a pilot clinical trial in adults with classic CAH and is initiating an open-label, single ascending dose trial in approximately 15 adolescent females with classic CAH, the 1401 Study.
The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.
EFPIA has appointed Joe Jimenez, CEO of Novartis, as its new president. He will work alongside Dr. Stefan Oschmann, CEO Pharma of Merck, and Marc de Garidel, chairman and CEO of Ipsen, who have been appointed as vice presidents by the board.
The rate of return on pharmaceutical R&D is on the rise for the first time since 2010. Since 2013, there has been an increase in R&D returns, from 5.1% to 5.5%, according to a study by Deloitte, a U.K. professional services firm.
Bristol-Myers Squibb and Japan-based companies Ono Pharmaceutical and Kyowa Hakko Kirin have entered into a clinical trial collaboration agreement to conduct a phase I combination study with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, and mogamulizumab, an anti-CCR4 antibody. The study, which will be conducted in Japan, will focus on evaluating the safety, tolerability and anti-tumor activity of combining Opdivo and mogamulizumab as a potential treatment option for patients with advanced or metastatic solid tumors.
Nine groups of scientists will receive funding totaling $5.9 million in 2014 to work together on increasing the understanding of sudden unexpected death in epilepsy (SUDEP), the leading cause of death from epilepsy. The consortium becomes the second Center Without Walls, an initiative to speed the pace of research on difficult problems in epilepsy by promoting collaborative research. The U.S. National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, funds this initiative.
CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has won a European Venture Contest award. The award program, which is part of the European Venture Summit, acknowledged CluePoints for its Central Statistical Monitoring (CSM) solution that employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data. The win represents the second industry award that CluePoints has secured this month after the company's risk-based monitoring solution also was recognized by the Scrip Awards.
The Illinois Biotechnology Industry Organization (iBIO) has elected several new additions to its board of directors. The new board members include Daniel Brennan of Lundbeck U.S., Jamie Oldani of Eli Lilly, Susanne Resatz of Vetter Development Services USA and Geeta Vemuri of Baxter Ventures.
Parent Project Muscular Dystrophy (PPMD), an advocacy organization working to end Duchenne muscular dystrophy, is urging Congress to build upon gains in recent years to further strengthen and enhance programs to ensure the patient voice is heeded during the drug development process. PPMD is advocating for provisions within the 21st Century Cures Initiatives focused on measuring how the agency is or is not using new patient engagement tools.
The Society for Clinical Research Sites (SCRS), an Ellicott City, Md.-based global trade organization representing the interests of clinical research sites, has announced a two-year collaboration with Clinical Ink, a Winston-Salem, N.C.-based provider of eSource solutions for clinical trials. Clinical Ink will participate as a Global Impact Partner (GIP).
Silicon Valley-based Vital Connect’s FDA-cleared wearable biosensor, HealthPatch MD, now is available for use in clinical trials in partnership with Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences. HealthPatch MD can be used with Medidata’s technology platform, Medidata Clinical Cloud, and its mobile app for patient-reported outcomes, Medidata Patient Cloud, to further remote patient monitoring, which has the potential to make clinical trials more efficient.
Takeda Pharmaceutical has announced its global oncology business unit, headquartered in Cambridge, Mass., now will be called Takeda Oncology. The creation of Takeda Oncology will improve the company's ability to meet the unique and urgent needs of cancer patients, their loved ones and health care providers worldwide. Takeda will sustain its long-standing entrepreneurial approach to oncology R&D, while expanding its global commercial network and resources as Takeda Oncology.
TrialScope, a Jersey City, N.J.-based global provider of clinical trial transparency and compliance solutions, has made available the latest release of the PharmaCM platform (v.2.2) that automates and manages clinical trial results reporting via the EMA's European Clinical Trials Database (EudraCT).
The NIH, as part of a research partnership with the Patient-Centered Outcomes Research Institute (PCORI), has issued a request for applications (RFA) to study how to improve blood pressure control among populations at highest risk for suffering hypertension-related strokes, heart attacks and other cardiovascular events. PCORI is a Wash. D.C.-based independent nonprofit organization authorized by Congress.
Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences, has made available its enriched solution for risk-based monitoring (RBM) of clinical trial sites. The company’s previously announced acquisition of Patient Profiles, an early stage software company focused on improving clinical trial data quality, broadens Medidata’s best-in-class technology for RBM, a methodology for reducing trial costs while providing clinical data accuracy and quality.
For the treatment of type 2 diabetes in China, patient access to premium-priced agents is impeded as not all patients can afford these drugs, Burlington, Mass.-based Decision Resources Group has found. The National Reimbursement Drug List was last updated in 2009, and several antidiabetic drug classes (e.g. DPP-IV inhibitors and GLP-1 receptor agonist) are not covered, as they were only approved for use in China after 2009.
Preventing Surgical Fires: Collaborating to Reduce Preventable Harm (updated)
CRO Health Decisions, based in Durham, N.C., confirmed yesterday its founder and CEO Michael Rosenberg, M.D., MPH, died at 11 a.m. Monday in a private plane crash near Montgomery County Airpark in Gaithersburg, Md., a Washington, D.C. suburb.