United States

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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Quest Diagnostics

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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UT Southwestern to establish Center for Heavy Ion Radiation Therapy

Thursday, February 12, 2015 01:07 PM

UT Southwestern Medical Center is leading a Texas consortium of researchers to establish the country's first National Center for Heavy Ion Radiation Therapy that could provide clinical care and research using heavy particles for innovative new cancer treatments.

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Biorasi adds endocrinology division, to hire 30

Thursday, February 12, 2015 01:02 PM

Biorasi, a full-service CRO powered by ProAct+, has formed an endocrinology division established to consolidate and expand Biorasi market leadership in running clinical trials in diabetes and women’s health. The new division will be led by Bill Doyle, the division manager, out of the Miami, Fla. headquarters.

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Advanced Inhalation Therapies receives Orphan Drug designation Cystic Fibrosis treatment

Wednesday, February 11, 2015 03:04 PM

The FDA has granted Orphan Drug designation to AIT-CF, Advanced Inhalation Therapies' (AIT) proprietary high dose formulation of nitric oxide (NO) for adjunctive treatment of cystic fibrosis (CF). In the U.S., Orphan Drug designation provides a variety of incentives, including seven years of market exclusivity, should AIT-CF receive FDA approval.

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Panacea Pharmaceuticals engages Accelovance for clinical development

Wednesday, February 11, 2015 12:46 PM

Panacea Pharmaceuticals, based in Gaithersburg, Md., and Accelovance, a CRO headquartered in Rockville, Md., have established a clinical development services agreement to develop and advance Panacea's oncology immunotherapy pipeline. Accelovance will support Panacea's clinical development strategies by offering scientific/medical and regulatory experience, in addition to providing CRO support through project management, clinical monitoring, data management, biostatistics and safety services for Panacea's clinical trials.

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Lurie Cancer Center, NMDTI, Northwestern Memorial launch new research program

Friday, February 6, 2015 12:25 PM

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, in collaboration with the Northwestern Medicine Developmental Therapeutics Institute (NMDTI) and Northwestern Memorial Hospital, has launched a new research program, Northwestern Onco-SET (Sequence, Evaluate, Treat), to provide a more personalized, precision medicine option for cancer patients by combining oncology with genomics. This program initially will focus on patients with any type of cancer that is not responsive to traditional therapies.

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Icon, Carnegie Mellon partner to research ways to improve study patients' understanding of Informed Consent

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PSI, INC Research, Chiltern best with sites
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