Theorem Clinical Research

United States

Patient-initiated Guidance for Industry for Duchenne submitted to FDA

Wednesday, June 25, 2014 01:51 PM

Parent Project Muscular Dystrophy (PPMD) and a broad coalition of stakeholders have submitted the first-ever patient advocacy-initiated draft guidance for a rare disease to the FDA to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

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Treeway, Amarna Therapeutics collaborate

Monday, June 23, 2014 01:32 PM

Treeway, an Amyotrophic Lateral Sclerosis (ALS) R&D strategy-focused company, and Amarna Therapeutics have formed a collaboration to identify new therapeutic targets for the treatment of ALS.

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Atlantic Health System launches new web site for clinical trials, research education

Thursday, June 19, 2014 01:48 PM

Atlantic Health System has launched a new web site that provides information about open and enrolling clinical trials and research studies across Atlantic Health System medical centers. The tablet and smartphone-friendly web site, www.atlantichealth.org/research, features a search tool that allows visitors to easily find trials based on disease area, keywords and the name of physicians conducting trials.

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Report: More than 430 medicines in development for chronic diseases in elderly

Thursday, June 19, 2014 01:44 PM

America’s biopharmaceutical research companies are developing 435 innovative new medicines to target 15 leading chronic conditions affecting the Medicare population, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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TMF survey: technology adoption lagging, many sticking to paper and email

Monday, June 16, 2014 01:59 PM

Despite progress toward paperless clinical trials, email and paper remain the dominant forms of exchanging trial documents with sponsors and CROs, according to a new survey from Veeva Systems.

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Aspire IRB, Midlands IRB join WIRB-Copernicus Group

Monday, June 16, 2014 11:01 AM

Aspire IRB and Midlands IRB have joined the WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research.

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Burke Medical Research Institute receives $2M NIH grant for spinal cord repair

Friday, June 13, 2014 01:11 PM

Scientists at the Burke Medical Research Institute in White Plains, N.Y., have received a $2 million grant from the NIH to study ways to enhance the survival of cell transplants for spinal cord repair. Cell transplants are a potential therapy for spinal cord injuries, which affect hundreds of thousands of Americans and for which few treatment options currently exist.

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Cardiovascular Systems plans new corporate headquarters

Friday, June 13, 2014 01:07 PM

Cardiovascular Systems, a medical device company, has plans to build a new corporate headquarters in New Brighton, Minn. The 125,000-square-foot, two-story building will have space for more than 500 employees and contain dedicated R&D, training and education and manufacturing facilities. CSI’s headquarters will be located in the New Brighton Exchange, approximately 10 minutes from downtown Minneapolis.

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CSSi launches new division: CSSi LifeSciences

Thursday, June 12, 2014 01:32 PM

CSSi, a patient recruitment solutions provider, has formed a LifeSciences division. This entity was created to complement CSSi’s service offerings by providing guidance and support for all phases of the product lifecycle, from product concept and early planning to post-approval compliance and surveillance.

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FDA approves Bayer's Gadavist Injection for breast cancer

Thursday, June 12, 2014 12:41 PM

The FDA has approved a new indication for Bayer Healthcare’s Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two, multi-center, phase III studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.

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September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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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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July

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

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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