United States

FDA issues response letter for Aeterna Zentaris' Macrilen NDA

Friday, November 7, 2014 12:58 PM

Aeterna Zentaris, is a specialty biopharmaceutical company, has received a complete response letter (CRL) from the FDA for its NDA for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

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FDA selects Icon to work on PRO measures for pneumonia trials

Thursday, November 6, 2014 12:38 PM

Global CRO Icon, based in Dublin, has been awarded a project by the FDA to develop an industry-standard Patient Reported Outcome (PRO) measure that can be used in anti-bacterial drug development trials for hospital-acquired bacterial pneumonia (HABP). 

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Clinverse, ACRES partner

Thursday, November 6, 2014 12:37 PM

Clinverse, a Durham, N.C.-based provider of automated financial management technology solutions for clinical trials, and the Alliance for Clinical Research Excellence and Safety (ACRES), a Cambridge, Mass.-based, nonprofit dedicated to excellence in clinical research, have formed a strategic partnership. The alliance, focused on improving financial sustainability of clinical research sites, brings Clinverse’s investigator payment solutions to ACRES’ global site network.

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ERT acquires eClinical Insights

Thursday, November 6, 2014 12:36 PM

ERT, a Philadelphia, Pa.-based global solution provider for high-quality patient safety and efficacy endpoint data collection, has acquired eClinical Insights (eCI), a Cambridge, Mass.-based provider of cloud-based clinical trials management software.

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Report: Biosimilars could create $44B in healthcare savings

Wednesday, November 5, 2014 12:52 PM

Introducing competing biosimilar versions of complex biologic drugs used to treat illnesses such as cancer and rheumatoid arthritis could cut spending on biologics in the U.S. by $44 billion over the next decade, according to a new analysis from RAND, a Boston, Mass.-based nonprofit research organization that develops solutions to public policy challenges.

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ALS Association triples spending on research thanks to ice bucket donations

Monday, November 3, 2014 02:44 PM

Thanks to the summer’s Ice Bucket Challenge donations, the ALS Association will be tripling the amount of money it spends on amyotrophic lateral sclerosis (ALS) research. The funds also will support the association’s Certified Treatment Centers of Excellence, which provide evidence-based, multi-disciplinary ALS care and services in a supportive atmosphere with an emphasis on hope and quality of life.

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Profectus BioSciences receives $9.5M Department of Defense funding for Ebola

Friday, October 31, 2014 02:16 PM

The Department of Defense (DoD), through the Medical Countermeasure Systems-Joint Vaccine Acquisition Program (MCS-JVAP), has contracted the manufacture and IND-enabling preclinical testing of the Profectus trivalent Ebola/Marburg vaccine. Profectus BioSciences is a Baltimore, Md.-based clinical-stage vaccine company developing novel vaccines for the treatment and prevention of infectious diseases.

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Cancer Innovation Coalition calls for reinvigorated U.S. cancer innovation

Friday, October 31, 2014 02:10 PM

The Cancer Innovation Coalition (CIC) has gone to Capitol Hill to call for early legislative and regulatory action in 2015 that will reinvigorate cancer innovation in the U.S.

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MD Anderson Moon Shots Program begins to generate innovations

Friday, October 31, 2014 02:07 PM

Improved surgical outcomes for ovarian cancer, expanded potential impact for new drugs and a novel family outreach program to head off cancers fueled by known genetic risk mutations are among the early innovations of the University of TexasMD Anderson Cancer Center's Moon Shots Program.

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Cytomedix re-brands as Nuo Therapeutics

Friday, October 31, 2014 02:05 PM

Cytomedix, a Gaithersburg, Md.-based pioneer in biodynamic therapies, has launched its new corporate brand identity, Nuo Therapeutics. The company intends to change its corporate name to Nuo Therapeutics, following shareholder approval of the name change proposal at its Annual General Meeting of the company's shareholders on Nov. 12.

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CenterWatch Data Library
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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The CenterWatch Monthly

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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