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Lays Foundation for Direct-to-Patient Studies Using Patient Reported Outcomes + Medical Record Methods

RESEARCH TRIANGLE PARK, N.C. - Tuesday, November 6th 2012 [ME NewsWire]

(BUSINESS WIRE)-- A new pilot study from Quintiles’ Digital Patient Unit (DPU) confirms the reliability of patient-reported outcomes collected via patients recruited over the internet, demonstrating the viability of a new method for observational research that combines patient-reported outcomes and medical record data (PRO+MR).

Findings demonstrate that patients can be recruited, screened and enrolled directly from online patient communities for observational studies that collect patient-reported-outcomes and clinical data with ~75% of physicians contributing medical record information.

A Quintiles-authored article on the PRO+MR study, "Conducting Research on the Internet: Medical Record Data Integration with Patient-Reported Outcomes,” has been published by the peer-reviewed Journal o ... Read more »

Business Wire / ME Newswire

PARIS - Tuesday, November 6th 2012

Cartes 2012

Regulatory News:

Gemalto (Euronext NL0000400653 GTO), the world leader in digital security, won a new Sesames award at the 2012 CARTES & IDentification industry conference for its PrintPixel security feature. The winning innovation is being showcased on the Gemalto booth, Hall 3, Entrance.

"This Sesames award endorses our capacity in developing innovative products that lead to real-life applications and tangible benefits for service providers and end users, as part of our ongoing commitment to serving our customers with pioneering solutions that make them stay one step ahead,” commented Tan Teck-Lee, Gemalto’s Chief Innovation and Technology Officer. "The security features that are visible with the bare eye are always very efficient, easy to check by officials at border control and providing increased protection for citizens.”

PrintPixel™

PrintPixel is a highl ... Read more »

VIENNA - Tuesday, November 6th 2012 [ME NewsWire]

EMC Momentum 2012

(BUSINESS WIRE)-- euroscript has received this year’s EMC IIG President Award for Customer Satisfaction at EMC Momentum 2012.

For the past 25 years, euroscript has delivered top-quality services to its customers around the world, adapting to their needs, being flexible whenever required and mobilising its expertise to achieve optimum results. Since we know a satisfied customer is a loyal customer, euroscript has constantly searched for innovative approaches, developed add-ons to help customers get the best out of their technology and implemented architecture-based solutions suited to a wide range of highly specific environments.

Today, by presenting euroscript with this prestigious award, EMC recognizes euroscript’s excellence in delivering customer satisfaction and its ability to exceed customer expectations by providing the highest levels of satisfaction in terms of service and solutions.< ... Read more »

INGELHEIM, Germany - Tuesday, November 6th 2012

    New data presented at the AHA’s Scientific Sessions demonstrate antibody fragment antidote to be highly selective and specific for rapid reversal of the anticoagulant effect of dabigatran
    After successful completion of the pre-clinical research phase, Boehringer Ingelheim initiated the clinical phase I trial development of a specific antidote as a potential additional option for patient management during rare critical care situations and/or emergency surgery
    Despite the absence of a specific antidote, dabigatran proven to be highly effective for stroke prevention without increasing rate of bleeding versus warfarin

(BUSINESS WIRE/ ME NewsWire)-- For Non-US, Non-UK & Non-Canadian Media Only

New findings presented at the 2012 American Heart Association Scientific Sessions in Los Angeles provide early indications that a highly specific and selective antido ... Read more »

BUSINESS WIRE / ME NewsWire - INGELHEIM, Germany - Tuesday, November 6th 2012

New FDA data safety assessment supports previous clinical evidence on the safety of the anticoagulation therapy and reports new Pradaxa® and warfarin patients to have similar bleeding rates
Comprehensive efficacy and safety evaluation by the EMA leads to recommendation for renewal of the marketing authorisation for Pradaxa® to ensure ongoing patient benefit

For Non-US, Non-UK & Non-Canadian Media Only

Following independent regulatory appraisals of the safety and efficacy of the anticoagulation therapy Pradaxa®, both the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) have reconfirmed the positive benefit-risk profile of the treatment for prevention of stroke in patients with atrial fibrillation (AF)*.

On Friday 2nd November, the FDA published the results of a Mini-Sentin ... Read more »

BOSTON - Monday, November 5th 2012 [ME NewsWire]

Sapient EngagedNowSM Delivers Innovative Multi-Channel Customer Experiences through a Unified Platform

(BUSINESS WIRE)-- SapientNitro, part of Sapient (NASDAQ: SAPE), today announced the launch of Sapient EngagedNowSM, a robust cloud-based platform offering that gives marketers the ability to better engage today’s on-the-go consumers across an increasing array of digitally enhanced channels. With EngagedNow, brands can create immersive, multi-channel customer experiences -- without having to design, develop and support the infrastructure needed to enable these experiences.

EngagedNow is a platform suite that can be used broadly by marketers across a range of industries. The suite also includes unique offerings and modular capabilities to support the specific needs of industry verticals, including sports & entertainment (Sapient EngagedFanSM) and travel (Sapient EngagedTravelerSM). EngagedNow is the first end-to- ... Read more »

TOKYO - Saturday, November 3rd 2012 [ME NewsWire]

    Results were presented at the American Society of Nephrology 2012 annual "Kidney Week" meeting and published online in the New England Journal of Medicine (NEJM). The results are intended to form the basis of regulatory filings in multiple countries seeking a new drug approval in ADPKD
    Investigational Phase III trial met its primary efficacy endpoint, demonstrating reductions of change in total kidney volume for subjects receiving tolvaptan compared to placebo
    ADPKD is the most common inherited cause of kidney failure, accounting for about 5 percent of end-stage renal disease in the U.S. The diagnosed prevalence is estimated to be between 1:1000 and 1:4000 globally

(BUSINESS WIRE)-- Otsuka Pharmaceutical Co., Ltd. today announced that the clinical trial results for tolvaptan, an investigational drug for the treatment of ADPKD, were presented for the first time ... Read more »

HIGH POINT, N.C. - Saturday, November 3rd 2012 [ME NewsWire]

(BUSINESS WIRE)-- TransTech Pharma, Inc., announced today that recruitment of patients for its recently initiated, multi-center Phase 2 clinical trial of TTP054 in type 2 diabetics, is exceeding expectations with initial top line results available in early 2013. The 90-day proof of concept study is being conducted in type 2 diabetics not well controlled with approved oral anti-diabetic agents. TTP054 acts as an agonist of the glucagon-like peptide 1 receptor (GLP1r).

"Currently available anti-diabetic agents fall short in controlling diabetes in a large percentage of the affected population. Therefore, the search for novel drugs and mechanisms to address this huge unmet medical need is imperative,” said Dr. Adnan Mjalli, Chairman and CEO of TransTech Pharma. "Injectable GLP-1 analogues, have shown impressive efficacy in the treatment of type 2 diabetes but are associated with several side effects, including naus ... Read more »

BUSINESS WIRE / ME NewsWire MCLEAN, Va. - Thursday, November 1st 2012

Today, on World Food Day, Hilton Worldwideannounced multi-year partnerships with Feeding Americaand The Global FoodBanking Networkto secure food and reduce hunger in communities where it operates around the globe. The collaborations will enable Hilton Worldwide hotels to collect safe, surplus food from conferences and daily food and beverage operations that would otherwise be thrown away and make it available to those in need.

Feeding America and The Global FoodBanking Network will each connect Hilton Worldwide hotels with local food banks and their networks of local community agencies to facilitate food delivery to school feeding programs, food pantries, soup kitchens, hospices, after-school programs and other community programs that provide food to families in need of nourishing meals. In year one, Hilton Worldwide will pilot food donation systems in New York City, Washington, D.C., Chicago, San Fran ... Read more »

NEW YORK - Thursday, November 1st 2012 [ME NewsWire]

    Transaction Values Warnaco at $2.9BN – a 34% Premium Over its Last Closing Price
    Reunites the House of "Calvin Klein” to Ensure Single Brand Vision
    PVH Will Have Established Operations in Every Major Consumer Market Worldwide
    Acquisition Enhances PVH’s Long-Term Growth and Profitability Driven by "Calvin Klein” and "Tommy Hilfiger”
    Transaction Accretive to Year One Earnings by $0.35 Per Share, Excluding One-Time and Transaction Related Costs

(BUSINESS WIRE)-- PVH Corp. (NYSE: PVH) and The Warnaco Group, Inc. (NYSE: WRC) today announced that they have entered into a definitive merger agreement pursuant to which PVH will acquire Warnaco and holders of Warnaco common stock will receive $51.75 in cash and .1822 of a share of PVH common stock for each share of Warnaco common stock. The transaction values Warnaco at appr ... Read more »