United States

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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Celerion joins Cardiac Safety Research Consortium

Thursday, October 16, 2014 07:00 AM

Celerion, a Lincoln, Neb.-based provider of cardiovascular safety services in early clinical research, has become a member of the Cardiac Safety Research Consortium (CSRC). Celerion will engage with other thought leaders on key issues that impact cardiovascular safety, including discussions of alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.

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PhotoxAir reduces airborne bacteria in clinical trials

Thursday, October 9, 2014 11:54 AM

Wake Forest Baptist Medical Center, a North Carolina-based medical center, has announced that studies have conclusively demonstrated that the PhotoxAir purification system significantly reduced airborne bacteria in clinical trials conducted in an emergency department setting.

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Bristol-Myers Squibb withdraws NDA with FDA for asunaprevir

Thursday, October 9, 2014 11:51 AM

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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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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