United States

Recursion Pharmaceuticals wins $1.5M NIH grant for rare diseases

Thursday, February 26, 2015 03:28 PM

Recursion Pharmaceuticals, an emerging biotech company founded in 2013 based on technology developed at the University of Utah, has been awarded $1.46 million from the NIH via the National Center for Accelerating Translational Sciences (NCATS). Just over half of the award is available in the first year; the rest will come through in year two pending availability of funds and project progress. The award will support the further development of Recursion’s Drug Screening Platform for hundreds of rare genetic diseases.

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FDA approves new antibacterial drug Avycaz

Thursday, February 26, 2015 01:12 PM

The FDA has approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

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Baxter selects northern Illinois site for Baxalta global headquarters

Wednesday, February 25, 2015 11:25 AM

Baxalta, the biopharmaceutical company expected to separate from Baxter International in mid-year, will be headquartered in northern Illinois. A long-term lease agreement for an approximately 260,000-square-foot facility extends for more than a decade.

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MedImmune, NIST partner to advance development of biological therapies

Monday, February 23, 2015 01:06 PM

MedImmune, the global biologics R&D arm of AstraZeneca, and the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) have signed a five-year agreement to jointly support research that will help advance drug discovery and manufacturing. The effort will focus on tools and measurements that will be used in the development and production of biopharmaceuticals, which are drugs and treatments derived from biological, rather than chemical, sources.

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Crohn's & Colitis Foundation, UNC expand IBD patient-focused engagement

Friday, February 20, 2015 12:29 PM

The Crohn's & Colitis Foundation of America (CCFA) is collaborating with the University of North Carolina School of Medicine (UNC) to create a research partnership between patients with inflammatory bowel disease (IBD) and the scientific community. CCFA Partners is a "patient-powered research network" for Crohn's disease and ulcerative colitis (collectively known as IBD) that uses state-of-the-art bioinformatics to engage and gather information from patients that researchers can study and analyze along with clinical and other patient-generated data.

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Collegium Pharmaceutical files NDA with FDA for Xtampza ER

Thursday, February 19, 2015 01:15 PM

The FDA has accepted for filing Collegium Pharmaceutical’s NDA for Xtampza ER, its novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain. Collegium Pharmaceutical is a specialty pharmaceutical company focused on the development and commercialization of innovative abuse-deterrent treatments for chronic pain and other diseases

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FDA grants Genentech’s cobimetinib Priority Review for melanoma

Thursday, February 19, 2015 01:00 PM

The FDA has accepted and granted Priority Review for Genentech’s, a member of the Roche Group, NDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by Aug. 11.

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NIH trial compares three drugs for diabetic macular edema

Thursday, February 19, 2015 12:49 PM

In an NIH-supported clinical trial comparing three drugs for diabetic macular edema (DME), Eylea (aflibercept) provided greater visual improvement, on average, than did Avastin (bevacizumab) or Lucentis (ranibizumab) when vision was 20/50 or worse at the start of the trial. However, the three drugs resulted in similar average improvement when starting vision was 20/40 to 20/32. Investigators found no major differences in the safety of the three drugs. The trial was funded by the National Eye Institute (NEI), part of the NIH.

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Parexel continues to expand Site Alliance Network

Wednesday, February 18, 2015 11:51 AM

Parexel International, a global biopharmaceutical services provider, has announced the continued expansion of its clinical trial Site Alliance Network, an extensive network of investigator sites and site management organizations (SMOs) that enables Parexel to quickly access and enroll patient populations for clients' clinical trials worldwide.

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Clinical trials consultant, author Karen Woodin will be missed

Tuesday, February 17, 2015 10:23 AM

Karen Estelle Woodin, Ph.D., known in the clinical trials industry as a long-time industry consultant and author, passed away last week after a short bout with malignant endometrial cancer.  She was 74.

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Integrated research partnerships build momentum
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