United States

HHS provides more information about clinical trials to the public

Tuesday, September 20, 2016

In an effort to make information about clinical trials widely available to the public, the HHS has issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological and device products. At the same time, the NIH has issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

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Cystic Fibrosis Foundation opens research lab

Tuesday, September 20, 2016

The Cystic Fibrosis Foundation has announced the official opening of a new, one-of-a kind research facility in Lexington, Massachusetts. Operated by Cystic Fibrosis Foundation Therapeutics (CFFT), an affiliate of the CF Foundation, the lab is designed to identify and test potential therapies for rare and common mutations of cystic fibrosis, with the ultimate goal of bringing new treatments to people living with the disease.

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Fate Therapeutics, Memorial Sloan-Kettering partner on T-Cell Immunotherapies

Tuesday, September 13, 2016

Fate Therapeutics, a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, has announced a partnership with Memorial Sloan-Kettering Cancer Center for the development of off-the-shelf T-cell product candidates using engineered pluripotent cell lines. Research and development activities under the multi-year collaboration will be led by Michel Sadelain, M.D., Ph.D., director of the Center for Cell Engineering and the Stephen and Barbara Friedman Chair at Memorial Sloan-Kettering Cancer Center.

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NCI embraces scientific road map to achieve Cancer Moonshot goals

Tuesday, September 13, 2016

National Cancer Institute (NCI) Acting Director Douglas Lowy, M.D., has accepted the recommendations of a Blue Ribbon Panel (BRP) on 10 scientific approaches most likely to make a decade’s worth of progress against cancer in five years under the Cancer Moonshot. The report was presented by the BRP to the National Cancer Advisory Board (NCAB), and it was subsequently considered and accepted by the NCAB with revisions that reflect the NCAB’s discussion. An overview of the report was published today in the journal Science.

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Federal prize competition seeks innovative ideas to combat antimicrobial resistance

Tuesday, September 13, 2016

A federal prize competition launched calling for innovative ideas for rapid, point-of-care laboratory diagnostic tests to combat the development and spread of drug resistant bacteria, a rising public health threat. Antibiotic resistant bacteria cause at least 2 million infections and 23,000 deaths each year in the U.S., according to the Centers for Disease Control and Prevention.

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NIH award expands landmark Alzheimer’s biomarker study

Tuesday, September 13, 2016

The Alzheimer’s Disease Neuroimaging Initiative (ADNI)—the long-running NIH-supported study investigating brain and fluid biomarkers of the disease—enters a new phase of discovery with the launch of ADNI3. With the recent NIH award of approximately $40 million over the next five years—coupled with anticipated private sector contributions of $20 million through the Foundation for the National Institutes of Health (FNIH)—ADNI3 will use cutting-edge technologies in brain imaging as it recruits hundreds of new volunteers. Expansion of the groundbreaking study, now in its 12th year, will further develop ways to speed clinical trials by providing researchers the biomarkers needed to detect the onset and track the progression of Alzheimer’s disease.

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St. Jude Medical sues Muddy Waters and MedSec

Monday, September 12, 2016

St. Jude Medical, a global medical device company, has filed a lawsuit against Muddy Waters Consulting, Muddy Waters Capital, MedSec Holdings, MedSec and three individual defendants who are principals in these firms, for false statements, false advertising, conspiracy and the related manipulation of the public markets in connection with St. Jude Medical’s implantable cardiac management devices.

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