United States

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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RedHill RHB-104 gets FDA QIDP for Nontuberculous Mycobacteria Infections

Thursday, January 12, 2017

RedHill Biopharma, a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, has announced that RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections.

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