United States

HHS partners with GSK for new antibiotics

Wednesday, June 12, 2013 02:19 PM

GlaxoSmithKline and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), are collaborating to support the development of several antibiotics to fight antibiotic resistance and bioterrorism.

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Carolinas Research Associates merges with PMG Research

Tuesday, June 11, 2013 02:30 PM

PMG Research has merged with Carolinas Research Associates (CRA). PMG Research, headquartered in Winston-Salem, N.C., is a network of 10 wholly-owned clinical research sites in North Carolina, South Carolina and Tennessee. CRA is located in Charlotte, N.C., where PMG also has a research facility.

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BDSI to file NDA for Bunavail

Monday, June 10, 2013 11:49 AM

BioDelivery Sciences International (BDSI) had a positive pre-New Drug Application (NDA) meeting with the FDA regarding Bunavail for the maintenance treatment of opioid dependence.

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HemaQuest completes enrollment in phase IIb study

Monday, June 10, 2013 11:48 AM

HemaQuest Pharmaceuticals, a biotechnology company focused on developing small molecule therapeutics to treat hemoglobin disorders, has completed enrollment in a randomized, double-blind, placebo-controlled phase IIb study of HQK-1001 in patients with sickle cell disease.

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GrayBug names new business development head

Monday, June 10, 2013 11:47 AM

GrayBug, a company developing drug delivery systems and drugs to more effectively treat eye disease, has announced Gerald D. Cagle, Ph.D., has joined GrayBug as a senior advisor and head of business development.

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Quintiles Infosario wins Informatica Innovation Award

Monday, June 10, 2013 11:44 AM

Quintiles received the 2013 Informatica Innovation Award for “Enterprise Data Integration” through the Quintiles Infosario solution, to integrate and master both clinical research and healthcare data across numerous institutions and at a scale never before accomplished in the biopharmaceutical industry.

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AbbVie, Alvine collaborate on investigational oral therapy

Monday, June 10, 2013 11:28 AM

AbbVie and Alvine Pharmaceuticals, a developer of celiac disease therapeutics, have entered a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in phase II development.

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Kite Pharma names chief medical officer

Friday, June 7, 2013 02:10 PM

Kite Pharma, a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, has appointed Keith Nolop, M.D., chief medical officer. Nolop, with 20 years of drug development experience at both biotechnology and global pharmaceutical companies, was previously senior vice president of development and chief medical officer at Plexxikon.

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Cohera Medical completes enrollment of No-Drain Study

Friday, June 7, 2013 02:09 PM

Cohera Medical, a developer of absorbable surgical adhesives and sealants, has completed enrollment for its U.S. No-Drain Study for its lead product, TissuGlu Surgical Adhesive. The study has enrolled 130 patients at five centers in the U.S. and is investigating the safety and effectiveness of TissuGlu in the reduction of wound drainage, seroma development and other complications in abdominoplasty patients without the use of postoperative drains.

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Boston Scientific, PFDN collaborate on Uterine Prolapse treatment

Friday, June 7, 2013 02:03 PM

Global medical technology company Boston Scientific provided a research and education grant of more than $1 million to the Pelvic Floor Disorders Network (PFDN) for the SUPeR clinical trial.  The SUPeR study will evaluate treatment outcomes of two different surgical options for women with uterine prolapse, a form of pelvic organ prolapse. PFDN is funded by the NIH.

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