United States

Datatrak expands offices into Chicago

Monday, November 10, 2014 12:16 PM

Datatrak International, a developer of cloud-based, unified eClinical technologies for the clinical trials industry, will expand office locations to include downtown Chicago in early 2015.

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Stephen T. Sonis joins PlasmaTech Biopharmaceuticals' scientific advisory board

Friday, November 7, 2014 02:07 PM

PlasmaTech Biopharmaceuticals, a biopharmaceutical company advancing patient care in critical areas, has announced that Stephen T. Sonis, DMD, DMSc, has joined its scientific advisory board (SAB). A world-renowned expert in the clinical treatment and research of cancer-related mucosal toxicities, Sonis has collaborated with management in recent years on advancing the company's clinical efforts of its oral mucositis treatment, MuGard.

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Bill & Melinda Gates Foundation awards PATH $156M for malaria research

Friday, November 7, 2014 01:23 PM

The Bill & Melinda Gates Foundation, of Seattle, Wash., has awarded $156 million to PATH, a Seattle-based international nonprofit organization, to support the PATH Malaria Vaccine Initiative (MVI) in building new vaccines that will interrupt the cycle of malaria parasite transmission and help realize the "accelerating to zero" agenda. Such vaccines would ensure parasite reintroduction is prevented by providing what could be called an "immunological bed net."

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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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CWWeekly

December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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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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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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