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New ACRO survey: CRO members saw big growth in past decade

Friday, September 19, 2014 03:34 PM

The biopharmaceutical industry’s outsourcing strategy has enabled the eight members of the Association of Clinical Research Organizations (ACRO) to double in size over the past 10 years, today employing more than 100,000 professionals worldwide with a global payroll of nearly $6 billion.

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GlaxoSmithKline to pay $510.8M fine to Chinese government in bribery scandal

Friday, September 19, 2014 01:31 PM

GlaxoSmithKline has confirmed the Changsha Intermediate People’s Court in Hunan Province, China ruled GSK China Investment (GSKCI) has, according to Chinese law, offered money or property to non-government personnel in order to obtain improper commercial gains, and has been found guilty of bribing non-government personnel. The verdict follows investigations initiated by China’s Ministry of Public Security in June 2013. 

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AAHRPP accredits two organizations in U.S., one in Mexico

Friday, September 19, 2014 01:28 PM

The nonprofit Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited three more organizations, including two independent institutional review boards in Massachusetts and a second organization in Mexico.

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PCI acquires Biotec Services International

Friday, September 19, 2014 01:26 PM

PCI, a Philadelphia, Pa.-based global service provider, has acquired Biotec Services International. Biotec is a provider of clinical trial services and temperature controlled pharmaceutical services headquartered in Bridgend, Wales in the U.K. The addition significantly expands PCI's presence in the E.U. to support global investigational studies of medicinal products by adding packaging, storage and distribution capacity, as well as consultative services for clinical trial supplies.

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Evotec takes legal steps against Andromeda Biotech

Friday, September 19, 2014 01:26 PM

Evotec, a Germany-based drug discovery alliance and development partnership company, will take legal steps against Israel-based Andromeda Biotech to recover all Evotec claims and potential damages that result from recent incidents in relation to DiaPep277.

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Cancer Research U.K., Cancer Research Technology, Asterias Biotherapeutics partner

Friday, September 19, 2014 12:51 PM

Cancer Research U.K. and Cancer Research Technology (CRT), the charity's development and commercialization arm, have reached an agreement with Asterias Biotherapeutics, a California-based biotechnology company focused on regenerative medicine, to take forward Asterias' novel immunotherapy treatment AST-VAC2 into clinical trials in subjects with non-small cell lung cancer.

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ABPI comments on NICE’s response to value-based assessment consultation

Friday, September 19, 2014 12:50 PM

The National Institute for Health and Care Excellence (NICE) board has considered proposals on value-based assessment (VBA) following a three-month consultation.

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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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Delphinus appoints Mark J. Forchette president and CEO

Thursday, September 18, 2014 02:36 PM

Delphinus Medical Technologies, a Michigan developer of SoftVue, a whole breast ultrasound system that incorporates a ring transducer design, has named Mark J. Forchette president and CEO.

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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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September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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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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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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