Theorem Clinical Research

United States

BARDA extends contract with Cytori for thermal burn treatment

Wednesday, August 20, 2014 01:29 PM

Cytori Therapeutics, a California-based developer of cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions, and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, have announced the execution of a contract option to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries.

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MMS Holdings, Oncology Trials Insights partner on oncology support services

Wednesday, August 20, 2014 01:24 PM

MMS Holdings, a Mississippi-based global CRO that focuses on regulatory submission support, and Oncology Trials Insights (OTI), a Colorado-based organization of oncology key opinion leaders that architect superior clinical trial strategies and facilitate improved decision-making, have partnered to deliver comprehensive oncology support services.

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FDA approves Biogen Idec’s Plegridy for multiple sclerosis

Monday, August 18, 2014 09:13 AM

The FDA has approved Biogen Idec’s Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.

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FDA approves Avastin to treat aggressive and late-stage cervical cancer

Friday, August 15, 2014 12:43 PM

The FDA has approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

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FDA approves new sleep drug Belsomra

Friday, August 15, 2014 09:17 AM

The FDA has approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

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Igenica Biotherapeutics awarded SBIR grant for antibody drug conjugate technology

Friday, August 8, 2014 01:09 PM

Igenica Biotherapeutics, focused on the discovery and development of innovative cancer antibody-drug conjugates (ADCs), has been awarded a $215,740 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to support continued development of its SNAP site-specific ADC linker technology.

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FDA approves Orbactiv to treat skin infections

Friday, August 8, 2014 12:44 PM

The FDA has approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

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Marathon Pharmaceuticals opens bioscience center in Chicago

Thursday, August 7, 2014 09:00 AM

Marathon Pharmaceuticals has opened the Marathon Bioscience Center in Chicago. The facility houses the company’s research, clinical and regulatory staff, who develop and register new treatments for rare diseases.

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NIH awards $14.5M to research groups studying DNA sequencing techniques

Tuesday, August 5, 2014 09:00 AM

A number of micro-sized technologies—such as nanopores and microfluidics—are among the approaches researchers will use to develop high-quality, low-cost DNA sequencing technology through new grants from the NIH. The grants, which total approximately $14.5 million to eight research teams over two to four years as funds become available, are the last to be awarded by the Advanced DNA Sequencing Technology program of the National Human Genome Research Institute (NHGRI), a part of NIH.

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FDA expands approval of Lumizyme to treat Pompe disease

Monday, August 4, 2014 03:27 PM

The FDA has approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than eight years of age. In addition, the risk evaluation and mitigation strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.

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September 15

WIRB-Copernicus Group acquires New England IRB

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

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Benefits outweigh the complexities, challenges of finding right vendors

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IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
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