AiCure

United States

Bristol-Myers Squibb withdraws NDA with FDA for asunaprevir

Thursday, October 9, 2014 11:51 AM

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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Quest Diagnostics names Franklin R. Cockerill VP, chief laboratory officer

Thursday, October 9, 2014 11:10 AM

Quest Diagnostics, a provider of diagnostic information services, has announced that Franklin R. Cockerill, III, M.D., has joined the company as vice president and chief laboratory officer, effective Oct. 1.

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Second Genome, Mayo Clinic collaborate to develop microbiome therapeutics

Thursday, October 9, 2014 09:00 AM

Second Genome, a South San Francisco, Calif.-based developer of novel medicines through innovative microbiome science, has entered into an extensive partnership with the Minnesota-based Mayo Clinic Center for Individualized Medicine to support the development of therapeutic products for multiple disease indications, starting with inflammatory bowel disease, metabolic disorders and colorectal cancer.

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NanoString, Brigham and Women's Hospital collaborate

Thursday, October 9, 2014 08:30 AM

NanoString Technologies, a Seattle, Wash.-based provider of life science tools for translational research and molecular diagnostic products, has signed a multi-year, multi-investigator research collaboration with Harvard-affiliated, Boston, Mass.-based Brigham and Women's Hospital (BWH) to accelerate the translation of genomic biomarker discoveries into clinical cancer diagnostics. Using NanoString's Elements reagents, assays will be developed to detect gene expression, copy number variations and fusions from a diverse range of tumor samples.

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DPx to expand facility in North Carolina, add 488 jobs

Thursday, October 9, 2014 08:00 AM

DPx, the “umbrella name” for Patheon’s three business units specializing in pharmaceutical services, fine chemicals and proprietary products and technologies, will expand operations in Pitt County, N.C. The company plans to create 488 jobs in Greenville, N.C. by the end of 2019 and invest $159 million to increase the site’s capabilities, as well as modernize the site and develop energy efficiency programs at the facility.

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Allied Minds launches Novare Pharmaceuticals

Wednesday, October 8, 2014 01:47 PM

Allied Minds, a Boston, Mass.-based science and technology development and commercialization company, has launched Novare Pharmaceuticals, a biotechnology company focused on developing therapeutic products that help the body replenish and rebuild itself using its own tissue through the modulation of Receptor for Hyaluronan Mediated Motility (RHAMM). Modulation of RHAMM also is of benefit in inflammatory diseases such as bronchopulmonary dysplasia (BPD).

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Report: Past drug failures vital to drug development process

Wednesday, October 8, 2014 01:36 PM

A number of investigational cancer medicines that did not succeed in clinical trials, so-called "failures," are a critical part of the drug development process, according to a report by the Wash. D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA).

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RxTrials names Adam Chasse president

Wednesday, October 8, 2014 01:33 PM

Ellicott City, Md.-based RxTrials, an investigative site network and consulting firm, has appointed Adam Chasse president.

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INC Research files for initial public offering

Tuesday, October 7, 2014 12:27 PM

INC Research Holdings, which has spent the past two decades acquiring 10 companies, has announced plans for an initial public offering expected to raise $150 million.

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PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

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CROs driving changes in patient recruitment
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Trials with in-home nurses poised to grow
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