United States

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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BBK acquires MEDL Mobile, company instrumental in developing its leading mobile app

Thursday, October 16, 2014 02:37 PM

BBK Holdings announced this morning it will acquire the custom application development division of MEDL Holdings, a developer of mobile applications that has been a long-time partner and collaborator in BBK’s mobile application for patient and site engagement, My Clinical Study Buddy.

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NIH awards $15.6 million for pulmonary research program

Thursday, October 16, 2014 02:29 PM

The NIH has awarded up to $15.6 million in grants over five years to the University of North Carolina, Chapel Hill (UNC-CH) and the University of Colorado, Denver (UCD) to conduct research with mucolytic agents discovered by Parion Sciences, a Durham, N.C.-based company focused on pulmonary and ocular diseases, and to enable Investigational New Drug applications for Parion's molecules.

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Novartis publishes CTL019 data for acute lymphoblastic leukemia

Thursday, October 16, 2014 11:55 AM

Novartis and the University of Pennsylvania's Perelman School of Medicine have announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine (NEJM) evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor (CAR) therapy CTL019.

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FDA approves Ofev to treat idiopathic pulmonary fibrosis

Thursday, October 16, 2014 11:49 AM

The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

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CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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