2014

ADDF, Alzheimer’s Society U.K. to test erectile dysfunction drug as dementia treatment

Friday, December 12, 2014

The Alzheimer’s Drug Discovery Foundation (ADDF), based in New York, and the Alzheimer’s Society U.K. have announced new funding to explore the possibility of using a commonly prescribed drug which treats erectile dysfunction as the next treatment for dementia. Tadalafil—part of the same class of drugs as Viagra—is to be one of the major research programs funded by the two charities in a cross-Atlantic research partnership. This is the first ever study researching the use of an erectile dysfunction drug for vascular dementia.

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Amgen initiates trial of Talimogene Laherparepvec and Merck’s Keytruda

Thursday, December 11, 2014

Amgen has initiated a trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, in combination with an investigational use of Merck‘s FDA approved, anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma. The trial has enrolled its first patient and will evaluate the combination of these two therapies in approximately 110 patients across 35 clinical trial sites in the U.S., Australia and Europe.

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Neurocrine Biosciences expands clinical pipeline

Thursday, December 11, 2014

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.

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FDA expands Gardasil 9 approval

Thursday, December 11, 2014

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.

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Report: Return on pharmaceutical R&D on the rise

Thursday, December 11, 2014

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.

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Ono Pharmaceutical, Bristol-Myers Squibb, Kyowa Hakko Kirin partner

Thursday, December 11, 2014

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.

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NIH initiates Centers Without Walls, awards $5.9M in funding

Thursday, December 11, 2014

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.

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CluePoints wins European Venture Contest award

Thursday, December 11, 2014

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.

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