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RTI International develops novel lung-on-a-chip

Wednesday, August 20, 2014 01:27 PM

Researchers at RTI International, a nonprofit organization headquartered in Research Triangle Park, N.C., that provides research and technical services, in collaboration with the University of North Carolina at Chapel Hill, have developed a new lung-on-chip microdevice for laboratory studies of respiratory challenges and therapeutics. The microdevice includes multiple vertically stacked cellular layers that mimic the structure of the airway tissue. 

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WIRB Copernicus Group

Valeant extends offer to acquire Allergan

Wednesday, August 20, 2014 01:26 PM

Valeant Pharmaceuticals International has extended the expiration of its exchange offer to acquire all outstanding shares of Allergan to 5:00 p.m., New York City time, Dec. 31. The exchange offer previously was scheduled to expire at 5:00 p.m., New York City time, Friday, Aug. 15. All other terms and conditions of the exchange offer remain unchanged.

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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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Roche, Garvan Institute of Medical Research partner

Wednesday, August 20, 2014 01:22 PM

Roche and the Australia-based Garvan Institute of Medical Research are collaborating to develop new technologies for targeted epigenomic analysis using DNA sequencing. Genomics is a rapidly evolving field with a focus on realizing the potential use of sequencing information in patient diagnosis and treatment.

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A*STAR, Sumitomo Mitsui Banking ink MOU for Japanese R&D in Singapore

Wednesday, August 20, 2014 01:19 PM

The Singapore-based Agency for Science, Technology and Research (A*STAR) and Japan-based Sumitomo Mitsui Banking Corporation (SMBC) have inked a memorandum of understanding (MOU), with the aim of supporting Japanese R&D activities in Singapore for the next three years.

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Nanotherapeutics opens new office in Maryland

Wednesday, August 20, 2014 01:17 PM

Nanotherapeutics, an integrated biopharmaceutical company with a focus on development and manufacturing, has opened a new office in Frederick, Md. The office was established to better support the company’s U.S. government contracts. With headquarters in Alachua, Fla., and a clinical team in Durham, N.C., Nanotherapeutics now has three strategically located offices.

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Recipharm to acquire Corvette Pharmaceutical Services Group for $159.4M

Wednesday, August 20, 2014 01:15 PM

Recipharm, a Sweden-based contract development and manufacturing organization, has signed an agreement to acquire Milan-based Corvette Pharmaceutical Services Group from Italian private equity group LBO Italia Investimenti.

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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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The Pulse on Study Conduct

Monday, August 18, 2014 07:00 AM

In the conduct of clinical trials, proper delegation of responsibilities to appropriately informed, experienced research staff is not merely encouraged, but required of the Principal Investigator (PI).

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MD Anderson, Foundation Medicine partner

Friday, August 15, 2014 02:52 PM

The University of TexasMD Anderson Cancer Center has announced an alliance with Cambridge, Mass.-based Foundation Medicine. The teams are opening a randomized, controlled trial to determine whether targeted therapies selected based on tumor molecular profiling compared with treatment not selected on this basis results in longer progression-free survival in patients with advanced disease.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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

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