Theorem Clinical Research

United States

Xiaflex approved for concurrent treatment in Dupuytren's contracture patients

Friday, October 24, 2014 12:48 PM

Auxilium Pharmaceuticals has announced that the FDA has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.

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TWi Biotechnology receives Orphan Drug designation for AC-201

Thursday, October 23, 2014 03:29 PM

TWi Biotechnology has received the designation of Orphan Drug from the FDA for using AC-201 to treat epidermolysis bullosa (EB). TWi Biotechnology has developed proprietary formulations to be used topically for the indication of EB.

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Adheris Health, Behavioral Insights Group launch ethnographic study

Thursday, October 23, 2014 01:51 PM

Adheris Health, an inVentiv Health company and a provider of medication adherence programs, has announced the start of the next phase of an ethnographic study into how Americans make healthcare decisions and the role of American culture in influencing health behaviors.

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aTyr Pharma appoints John C. McKew vice president, research

Thursday, October 23, 2014 01:45 PM

aTyr Pharma, an innovative rare disease therapeutics enterprise, has announced that John C. McKew, Ph.D., has joined the company as vice president, research. McKew brings more than two decades of experience in translational research, including key leadership positions at the NIHWyeth Research and Genetics Institute (prior to its acquisition by Wyeth). McKew will lead aTyr's efforts to expand and translate its novel Physiocrine biology into meaningful therapeutics to treat rare, grave immune-driven disorders.

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ALS ACT, ALS Association, Northeast ALS Consortium request proposals

Thursday, October 23, 2014 01:12 PM

ALS ACT, a novel academic-foundation-industry partnership; the ALS Association, a Wash. D.C.-based national nonprofit organization; and the translational Northeast ALS Consortium (NEALS) clinical trials network have announced a call for phase II clinical trial applications for novel, high-potential treatments in amyotrophic lateral sclerosis (ALS).

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Profectus BioSciences receives Army funding for Ebola, Marburg viruses

Thursday, October 23, 2014 01:06 PM

Profectus BioSciences, a Baltimore, Md.-based clinical-stage vaccine company, and the Galveston National Laboratory (GNL) at the University of Texas Medical Branch at Galveston (UTMB) have received a three-year $8.5 million grant from the U.S. Army. The grant will support studies directed at early steps of the ongoing development of a vaccine to provide pre- and post-exposure protection against exposure with all major strains of Ebola and Marburg viruses.

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RHO awarded contract from National Institute of Dental and Craniofacial Research

Wednesday, October 22, 2014 11:40 AM

Rho, a Chapel Hill, N.C.-based CRO, has renewed an existing federal contract with the National Institute of Dental and Craniofacial Research (NIDCR), a part of the Health and Human Services and NIH. Rho will provide clinical research operations and management support to the NIDCR and to NIDCR funded clinical research studies from study preparation and initiation through study completion and close-out.

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Inovio Pharmaceuticals, MedImmune, University of Pennsylvania partner

Wednesday, October 22, 2014 11:39 AM

The Defense Advanced Research Projects Agency (DARPA) has awarded $12.2 million for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of PennsylvaniaInovio Pharmaceuticals and MedImmune, the global biologics R&D arm of AstraZeneca. The group will develop DNA-based monoclonal antibodies (mAbs) for infectious disease treatment. DARPA is an agency of the U.S. Department of Defense that creates and supports novel technologies important for national security.

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National Alzheimer's Plan milestones must be strengthened to meet 2025 goal

Wednesday, October 22, 2014 11:33 AM

The U.S. government has initiated a major effort to prevent and effectively treat Alzheimer's disease by 2025. However, a workgroup of nearly 40 Alzheimer's researchers and scientists said the research milestones in the U.S. government's National Plan to Address Alzheimer's Disease must be broadened in scope, increased in scale and adequately funded in order to successfully achieve this goal. A series of proposals by the workgroup to enlarge and strengthen the plan have been published in Alzheimer's & Dementia: the Journal of the Alzheimer's Association.

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Fidelity Biosciences and Atlas Venture launch Unum Therapeutics

Wednesday, October 22, 2014 11:28 AM

Fidelity Biosciences and Atlas Venture, with participation from Sanofi-Genzyme BioVentures, have launched Unum Therapeutics, a company developing cellular immunotherapy to treat cancer. Fidelity Biosciences invests venture capital in biopharmaceutical, medical technology, healthcare information technology and healthcare service companies, while Atlas Venture is an early-stage investor. All three are based in Cambridge, Mass.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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