United States

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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Kathy Bates to be honored at Research!America advocacy awards dinner

Friday, January 20, 2017

Kathy Bates, award-winning actress and Lymphatic Education & Research Network (LE&RN) spokesperson, will receive Research!America’s Isadore Rosenfeld Award for Impact on Public Opinion for raising the visibility of lymphedema and lymphatic diseases and advocating tirelessly on behalf of the patient community. The Rosenfeld Award is presented to individuals who have worked to effectively deliver medical or other health-related research advocacy messages to the public.   

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Xcovery joins NCI Formulary to help expedite cancer clinical trials

Wednesday, January 18, 2017

Xcovery, a developer of targeted therapeutics for cancer, has announced its participation in the NCI Formulary, a public-private partnership between the National Cancer Institute (NCI), part of the NIH, and pharmaceutical and biotechnology companies to expedite the use of agents in clinical trials. The partnership, which launched last week with fifteen targeted agents from six pharmaceutical companies, will seek to alleviate the lengthy process to develop new therapies for patients, and respond to the call for greater collaboration within the industry made by Vice President Biden’s Cancer Moonshot Initiative.

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Shionogi announces positive results for Cefiderocol pivotal cUTI trial

Tuesday, January 17, 2017

Shionogi has announced that cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, met the FDA pre-specified primary endpoint for non-inferiority vs imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with Gram-negative bacteria. Cefiderocol was superior to IPM/CS at test of cure (TOC).

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MRC Technology Centre relocates to expand diagnostics research capability

Tuesday, January 17, 2017

MRC Technology, an independent medical research charity, has announced the relocation of its Centre for Diagnostics Development (CDD) to Nine, Edinburgh BioQuarter, in the U.K. The move forms part of the charity’s investment of over £7 million over the next five years to further its work accelerating diagnostic research into the clinic. CDD will potentially double its headcount over the same period.

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Exco InTouch receives privacy shield framework self-certification

Tuesday, January 17, 2017

ERT company Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has formally received EU-U.S. Privacy Shield Framework Self-Certification status by the U.S. Department of Commerce’s International Trade Administration (ITA). The designation certifies that Exco InTouch’s practices meet or exceed the data privacy and security principles outlined by U.S. Department of Commerce and European Commission.

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