Theorem Clinical Research

United States

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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AWARE for All Clinical Research Education Day returns to Boston

Monday, August 4, 2014 02:53 PM

The Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process, has announced the return of AWARE for All Boston, a free event designed to promote understanding and dialogue around clinical research participation.

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Optim Oncology, Urology Centers of Oklahoma join U.S. Oncology Network

Monday, August 4, 2014 01:59 PM

Optim Oncology and Urology Centers of Oklahoma, divisions of Oklahoma Multispecialty Group, have joined U.S. Oncology Network, a network of integrated, community-based, physician-owned oncology practices dedicated to advancing high-quality, evidence-based cancer care.

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FDA approves Jardiance to treat type 2 diabetes

Friday, August 1, 2014 01:33 PM

The FDA has approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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Rho named a Best Place to Work by Triangle Business Journal

Thursday, July 31, 2014 11:36 AM

Rho, a CRO focused on bringing new products to market through a full range of product development services, has been named by Triangle Business Journal a winner of Best Places to Work. The award is part of the publication's annual Best Places to Work Awards program and recognizes Rho’s achievements in creating a positive work environment that attracts and retains employees through a combination of benefits, working conditions and company culture.

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NIH programs to focus on emerging areas of science

Wednesday, July 30, 2014 12:40 PM

Scientific areas ripe for targeted investments in technology development and research to improve health are the focus of new programs of the NIH’s Common Fund. The programs include work to facilitate the study of how sugar modifications affect proteins, to understand the arrangement of DNA within cells in four dimensions and to enable the development of new therapies that allow control of organ function through manipulation of nerves.

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Life expectancy gains threatened as more older Americans suffer from multiple medical conditions

Friday, July 25, 2014 01:01 PM

With nearly four in five older Americans living with multiple chronic medical conditions, a new study by researchers at Johns Hopkins Bloomberg School of Public Health finds the more ailments you have after retirement age, the shorter your life expectancy. The analysis, one of the first to examine the burden of multiple chronic conditions on life expectancy among the elderly, may help explain why increases in life expectancy among older Americans are slowing.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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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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