Theorem Clinical Research

United States

Sigma-Aldrich, University of Michigan Medical School partner

Friday, September 19, 2014 12:45 PM

Sigma-Aldrich (SIAL), a St. Louis, Mo.-based life science and high technology company, has entered into a new gene editing partnership with the University of Michigan (U-M) Medical School's Vector Core. Sigma-Aldrich will provide the Vector Core with Sigma CRISPR technology, experimental design consultation and dedicated gene editing bioinformaticians.

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FDA approves STENDRA for ED

Thursday, September 18, 2014 02:21 PM

The FDA has approved a supplemental new drug application (sNDA) for Vivus’ STENDRA (avanafil). STENDRA now is the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.

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FDA approves MOVANTIK (naloxegol) for opioid-induced constipation

Thursday, September 18, 2014 01:05 PM

The FDA has approved AstraZeneca’s MOVANTIK (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain.

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Covance, Frenova Renal Research collaborate

Wednesday, September 17, 2014 02:23 PM

Covance, a Princeton, N.J.-based global drug development services company, and Frenova Renal Research, a Fresenius Medical Care North America (FMCNA) company based in Waltham, Mass., have announced a new research collaboration designed to find more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).

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NIH awards $64M for the understanding of cell pathways, development of new therapies

Tuesday, September 16, 2014 09:00 AM

Building on a successful three-year pilot project, the NIH has awarded more than $64 million to six research institutions to create a database of human cellular responses, the Library of Integrated Network-based Cellular Signatures (LINCS).  Discovering such cell responses will improve scientists’ understanding of cell pathways and aid in the development of new therapies for many diseases.

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Synergistix, MedPro Systems partner

Tuesday, September 16, 2014 07:55 AM

Synergistix, a Sunrise, Fla.-based provider of customer relationship management (CRM) solutions for life sciences, has partnered with MedPro Systems, an Arlington, N.J.-based healthcare licensing solution for pharmaceutical and device industries.

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Lupus Research Institute holds NYC's first Lupus Trials Fair

Monday, September 15, 2014 12:39 PM

Over 200 patients, families, physicians and scientists came together under one roof last Friday, Sept. 12, to learn, interact and participate in the drive for better lupus treatments at New York City's first Lupus Trials Fair, launched by the Lupus Research Institute (LRI) and the S.L.E. Lupus Foundation.

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Novartis to open Center for Advanced Cellular Therapeutics at University of Pennsylvania

Monday, September 15, 2014 12:29 PM

The University of Pennsylvania’s alliance with Novartis has unveiled plans for the construction of a first-of-its-kind Center for Advanced Cellular Therapeutics (CACT) on the Penn Medicine campus in Philadelphia.

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Cellerant awarded $47.5M for development of CLT-008 for acute radiation syndrome

Friday, September 12, 2014 01:16 PM

Cellerant Therapeutics, a California biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, has been awarded $47.5 million under a second option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the office of the assistant secretary for preparedness and response of the department of Health and Human Services.

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PhRMA: 44 medicines and vaccines in development for HIV/AIDS

Friday, September 12, 2014 01:13 PM

America’s biopharmaceutical research companies currently are developing 44 medicines and vaccines for HIV/AIDS treatment and prevention, according to the latest Medicines in Development report by the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA). A second report, The Value of Innovation in HIV/AIDS Therapy, a PhRMA-sponsored white paper by Boston Healthcare Associates (BHA), highlights the progress in HIV/AIDS treatment and its impact on patients afflicted with the disease. 

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September 22

Roche/Genentech plans pilot trial to measure patientpreference for participating at home v. at study site

Bipartisan 21st Century Cures initiative prepares to draft legislation to accelerate biomedical R&D, lower cost

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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