United States

NIH to expand critical catalog for genomics research

Monday, February 6, 2017

The NIH plans to expand its Encyclopedia of DNA Elements (ENCODE) Project, a genomics resource used by many scientists to study human health and disease. Funded by the National Human Genome Research Institute (NHGRI), part of NIH, the ENCODE Project is generating a catalog of all the genes and regulatory elements—the parts of the genome that control whether genes are active or not—in humans and select model organisms. With four years of additional support, NHGRI builds on a long-standing commitment to developing freely available genomics resources for use by the scientific community.

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Sanofi’s Xyzal Allergy 24HR FDA approved for over-the-counter use

Thursday, February 2, 2017

The FDA has approved Sanofi’s Xyzal Allergy 24HR as an over-the-counter (OTC) treatment for the relief of symptoms associated with seasonal and year-round allergies. Specifically, two formulations of Xyzal are now approved for OTC use 5mg tablets for ages 6 years and older, as well as 0.5 mg/mL oral solution for ages 2 years and older. Xyzal is an oral antihistamine with a proven 24-hour effect.

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NIH initiates pilot grant program for innovative neurological research

Friday, January 27, 2017

The first 30 recipients of the new R35 Research Program Award (RPA), a pilot program designed to encourage creative research by enhancing funding stability, have been announced by the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH. NINDS-supported investigators who secure an RPA will have their research funded for a period of five years, with the potential to have that funding extended for up to an additional three years. This funding initiative was developed to provide support for a grantee’s overall research program, not just individual projects. 

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Synergy’s Trulance FDA approved for chronic idiopathic constipation

Monday, January 23, 2017

The FDA has approved Synergy Pharmaceuticals’ Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

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Concert’s CTP-656 receives FDA Orphan designation for cystic fibrosis

Monday, January 23, 2017

Concert Pharmaceuticals has announced that the FDA has granted Orphan Drug designation for CTP-656, Concert’s next generation CFTR potentiator being developed for the treatment of cystic fibrosis. In December 2016, Concert initiated a phase II trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline results from the phase II trial are expected by year-end 2017.

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FDA, IBM partner on the secure exchange of clinical data

Monday, January 23, 2017

Secure storage and controlled access to sensitive patient data are critical aspects of the clinical trial process. Investigators may need to access huge data sets shared across national and international sites. The amount and sheer number of types of data is rapidly increasing as the use of mobile and wearable devices and the querying of genomic databases are incorporated into trial design.

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Three Questions: Mohammad A. Millwala, DM Clinical Research

Monday, January 23, 2017

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Mohammad A. Millwala, CEO of DM Clinical Research, a network of investigative sites based out of Tomball, Texas. DM Clinical Research was a finalist for the Society for Clinical Research Sites’ 2016 Site Patient Recruitment Innovation Award (SPRIA), which recognizes research sites that have developed and implemented innovative patient recruitment programs.

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