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August 26, 2010

Uniplas Clinical Development Successfully Completed

Filed under: Press Releases — Tags: Clinical, Corinne Landolt, development, SUCCESSFULLY COMPLETED, UNIPLAS — The Editor @ 5:40 am

LACHEN, Switzerland, Aug. 26, 2010 (CRWENEWSWIRE) - Octapharma AG, one of the largest private manufacturers of plasma products in the world, announced today that the clinical development for Uniplas® has been successfully completed. The product has been filed for registration in Europe and will be submitted later in the USA.

Uniplas®, is a novel, blood group independent, universally applicable, prion depleted, solvent/detergent treated, human pooled plasma for infusion. Uniplas® can be given to all patients irrespective of their blood group, thus abolishing the risks and serious consequences that can result from a transfusion of an incompatible plasma unit. Uniplas® is obtained by optimal mixing of plasma of different blood groups in order to neutralize the unwanted anti-A and anti-B antibodies (both IgM and IgG class) by binding to free A and B substances. When transfusing plasma, incompatibility between donor and patient arises when the donor plasma includes antibodies against the A or B antigens of the recipient. Thus, the transfusion of such incompatible plasma can have serious consequences in patients. At present, only plasma of blood group AB can be used as universal plasma as it contains neither anti-A nor anti-B antibodies. However the availability of AB plasma is limited, with only 3-5% of Caucasians or Afro-Americans having this blood group. Apart from delays in transfusion, mismatch errors in transfusing incompatible plasma can be equally critical and sometimes fatal to the recipient, and such risks would be eliminated by a universal plasma.

The safety measures used in the production of Uniplas® are the same as used for the commercially available Octaplas®/ OctaplasLG®(1). For Uniplas®, the effective and reliable inactivation/ neutralization of both enveloped and non-enveloped viruses is achieved by S/D (Solvent Detergent) treatment and immune neutralization. The additional advantages associated with Uniplas® are the same as for the commercially available Octaplas®, such as: standardized coagulation factors content and no risk of transfusion-associated acute lung injury (TRALI). Furthermore, the newly developed LG technology successfully eliminates prions, so that the total prion removal capacity of the entire Uniplas® manufacturing process is greater than 3.0 Log10(2).

The efficacy of Uniplas® (non-LG) has been proven in clinical trials conducted in patients undergoing liver resection or open-heart surgery (3,4). Recently, a new Phase I, randomized, double-blind, active controlled clinical trial has been published. The aim of this study was to demonstrate that the introduction of the LG technology does not affect the efficacy and tolerability of Uniplas® and has the same safety profile as the blood group dependent OctaplasLG®. Following plasmapheresis (PPh) of 60mL, the 30 volunteers with blood groups A, B or AB were randomized to receive transfusions of 1,200mL OctaplasLG® or Uniplas®. One of the measurements performed in the study was the direct antiglobulin test (DAT), which is one of the most sensitive assays for assessing haemolytic reactions. All DAT assays in the volunteers were negative. Thus no sensitizing of red blood cells, leading potentially to haemolytic reactions after transfusions of either Uniplas® or octaplasLG® occurred., The current investigation in healthy volunteers indicated that haemolysis is unlikely to be an issue when Uniplas® is administered at a therapeutic dose. This supports the previous results (Uniplas® non-LG) from clinical trials in patients with liver resection and open-heart surgery.

Uniplas® is currently under a DCP (Decentralized Procedure) registration procedure in Europe and it is expected to be finished on the Q4 2010. Following European approval, Octapharma plans to start the approval process for Uniplas® in the USA.

About Octapharma

The Octapharma Group is an independent, Swiss-based biopharmaceutical company operating worldwide. Octapharma’s core business is the development, production, and sale of high-quality human proteins for the treatment of life-threatening diseases.

The Group has more than 4,200 employees in 28 countries, and owns five modern, state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico, respectively.

Octapharma’s company mission is to provide safe and effective biopharmaceutical products derived from human cells or blood plasma to patients in need of lifesaving therapy.

For more information about the company please click here.

About OctaplasLG® and Uniplas®:

Uniplas® and OctaplasLG® are both S/D treated, coagulation active, pooled plasmas for transfusion. OctaplasLG indicated for a variety of situations, including: complex deficiencies of coagulation factors, massive bleeding, or when there is a requirement for plasma exchange.
Uniplas® shares the favorable characteristics of octaplasLG® in terms of quality and safety, in addition to offering the advantage of being a blood group independent option in the plasma transfusion setting. It is obtained by optimized integration of well defined ratios of plasma units derived from donations of blood groups A, B and AB.

References

1. Heger et al., Vox Sang. 2009; 97:219-225
2. Neisser-Svae et al., Vox Sang 2009; 97:226-233
3. Solheim BG et al., Vox Sang 2005; 89:19-26
4. Tollofsrud S et al., Vox Sang 2005; 89:19-26

Contact:
Octapharma AG Corinne Landolt Tel: +41 (55) 451 21 36corinne.landolt@octapharma.com

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August 20, 2010

ICON Appoints Alan Morgan To Role Of Group President, Clinical Research Services

Filed under: Press Releases — Tags: ALAN MORGAN, Clinical, GROUP PRESIDENT, ICON APPOINTS, Mr. Peter Gray CEO, Research, services — The Editor @ 3:12 am

DUBLIN, Aug. 20, 2010 (CRWENEWSWIRE) - ICON plc (NASDAQ:ICLR - News) (ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the appointment of Mr. Alan Morgan to the position of Group President, Clinical Research Services.

Mr. Morgan is currently Group President, ICON Early Phase and Laboratory Services, and prior to that was Chief Operating Officer of the ICON Clinical Research division, having joined ICON in 2006. Alan has over 20 years experience working in both the pharmaceutical and the CRO industries. Prior to joining ICON, he was Vice President and Global General Manager of the Phase II/IV business of MDS Pharma Services, and he has also held senior positions in Covance, Glaxo Wellcome and ICI Pharmaceuticals.

ICON also announced that Ms Linda Meyerson has joined the company as Chief Operating Officer, ICON Clinical Research. Ms Meyerson will report directly to Mr. Morgan and brings over 30 years of pharmaceutical industry experience and drug development knowledge to the organisation. Prior to joining ICON, Ms Meyerson was Vice President, Global Clinical Operations for GlaxoSmithKline, having previously served in a similar global capacity for the Janssen Research Foundation and the RW Johnson Pharmaceutical Research Institute.

ICON also announced that Dr. John Hubbard, the former Group President, Clinical Research Services, is leaving the organisation to take up a senior role in a leading global biopharmaceutical company.

Commenting on the organisational changes, Mr. Peter Gray, CEO ICON plc said, “I would like to welcome Alan to his new role. He has been an outstanding member of our management team, and his deep knowledge of our clinical organisation and broad industry experience will be invaluable as we continue to develop our business.” Mr Gray added, “We are also delighted to welcome Linda to our team. Her extensive global drug development experience will be a huge asset to the organisation. We are sorry to lose John Hubbard, and I would like to acknowledge his outstanding contribution to ICON and wish him every success in his new challenging role.”

About ICON plc

ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The Company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 71 locations in 39 countries and has approximately 7,500 employees. Further information is available at www.iconplc.com.

ICON/ICLR-G

Contact:
ICON plc Funmi Ahmed-Onibudo + 44 (0) 20 7067 0214fahmed-onibudo@webershandwick.com

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August 12, 2010

Over 1000 Clinical Cases Evaluated Using IQQA®-Liver in Supporting Multidisciplinary Liver Imaging Evaluations

Filed under: Press Releases — Tags: Clinical, clinical computer, EDDA Technology, healthcare imaging, IT technology, liver cancer, modern multidisciplinary — The Editor @ 3:17 am

PRINCETON, N.J., August 12,2010 (CRWENEWSWIRE) — EDDA Technology announced today that the number of clinical cases evaluated for pre- and post- operative assessment using IQQA®-Liver in hospitals has exceeded 1000 examinations, since the first commercial system installation in Q2 2009. EDDA’s IQQA®-Liver, now marketed worldwide, is a comprehensive workflow solution supporting modern multidisciplinary liver imaging evaluation and management.

Primary liver cancer represents one of the most common malignancies in the world and accounts for almost 1.25 million deaths annually. In the US, liver disease is among the ten major causes of death. The management of hepatic tumors presents a challenging problem. Advanced preoperative imaging assessment is paramount in determining appropriate treatment, and requires the participation of a multidisciplinary team of surgeons, oncologists, hepatologists, and interventional radiologists specializing in liver malignancy.

IQQA®-Liver is designed to cope with such a challenge. It provides an innovative toolset for real-time interactive assessment and volumetric quantification of liver, liver lobes, hepatics lesions and vessels. With the intuitive and easy-to-use tools, physicians may in real-time perform virtual simulation of resection, lobular/segmental/vascular manipulation and quantification to achieve desired planning result typically within minutes.

EDDA’s proprietary IT technology allows enterprise-wide deployment of IQQA®-Liver via web so as to quick share data and results anywhere anytime among the multidisciplinary liver team.

IQQA®-Liver has clearance by the FDA, China SFDA, Taiwan DOH, and carries the CE mark. It is currently in use at numerous prestigious liver transplantation/surgery/interventional centers worldwide, including University of Colorado Hospitals Denver, Shanghai Zhongshan Hospital, Shanghai Ruijin Hospital, Tianjin First Center Hospital, Beijing You’an Hospital, Nanjing Gulou Hospital and etc.

In one study, University of Colorado Hospital Denver used IQQA®-Liver to retrospectively evaluate the entire living liver donor (LLD) candidate studies rejected in a 2 year period, and found that about 48% that were previously rejected due to anatomic abnormalities by conventional CT visualization could have favorable anatomy for LLD. According to Dr. Igal Kam, Chief of Transplantation, and Dr. Paul Russ, Professor of Radiology, “IQQA®-Liver allows for better understanding of surgical anatomy and surgical planning in the preoperative evaluation. This will have positive outcome on available livers and LLD selection.” Results will be presented at the XXIII International Congress of the Transplantation Society in Vancouver. EDDA will exhibit IQQA®-Liver at this congress (booth #38).

About EDDA Technology

EDDA Technology, Inc. is an innovative clinical computer solution provider in healthcare imaging and analysis. EDDA offers a series of next generation computer assistance solutions to the entire patient care management cycle, including enabling early detection and diagnosis of diseases, as well as enhancing efficiency and precision in treatment planning, management and follow-up. EDDA’s goal is to deliver, with broad accessibility, advanced information analysis technologies that improve clinical workflow and accuracy. A privately held Delaware corporation, EDDA is headquartered in Princeton, New Jersey, and has a subsidiary in Shanghai, China. IQQA® is a registered trademark of EDDA Technology. www.eddatech.com

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June 3, 2010

Surrey Clinical Research Centre Achieves MHRA Accreditation

Filed under: Press Releases — Tags: ACHIEVES, Clinical, MHRA, Research, SURREY — The Editor @ 5:31 am

GUILDFORD, England, June 3, 2010 (CRWENEWSWIRE) - The Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Surrey Clinical Research Centre (Surrey CRC) at the University of Surrey standard accreditation for conducting clinical pharmacology Phase I trials -

http://tinyurl.com/2fmgt7t

The accreditation scheme was introduced to improve the safety of clinical research volunteers and assesses the capability of the clinical research centre based on facilities, training and experience of staff. The accreditation gives additional reassurance and confidence that the Surrey CRC meets the highest of industry clinical research standards.

Dr Julia Boyle, Director of Surrey CRC, said: “I am very proud to announce the accreditation of the Surrey CRC by the MHRA. Our accreditation success reflects the strong commitment of the University of Surrey - and in particular the Surrey CRC team - to excellence and high-quality research. The Surrey CRC is embedded in an academic environment with international recognition for clinical research. In addition to our academic strength, the accreditation places us firmly alongside the best commercial clinical research organisations in the UK.”

Notes to Editors

About Surrey Clinical Research Centre

At Surrey Clinical Research Centre, part of the University of Surrey, we have a proven formula for success in clinical research, with a particular emphasis on sleep and human psychopharmacology. To date we have undertaken over 250 clinical trials including both volunteer and patient populations. We have the experience and expertise to develop quality, tailor-made solutions in a timely and flexible manner.

Working in collaboration with us enables access to: - 24 fully monitored sleep beds - Our experience of over 250 trials in human psychopharmacology - Full clinical support and project management - Highly experienced clinical trials staff - Complete data management and statistical analysis - Leading academic expertise - Large populations of healthy volunteers and patients - Our experience in regulatory submissions
About the University of Surrey

The University of Surrey is one of the UK’s leading professional, scientific and technological universities with a world class research profile and a reputation for excellence in teaching and research. Ground-breaking research at the University is bringing direct benefit to all spheres of life - helping industry to maintain its competitive edge and creating improvements in the areas of health, medicine, space science, the environment, communications, defence and social policy. Programmes in science and technology have gained widespread recognition and it also boasts flourishing programmes in dance and music, social sciences, management and languages and law. In addition to the campus on 150 hectares just outside Guildford, Surrey, the University also owns and runs the Surrey Research Park, which provides facilities for 140 companies employing 2,700 staff.

The Sunday Times names Surrey as ‘The University for Jobs’ which underlines the university’s growing reputation for providing high quality, relevant degrees.

Surrey is a member of the 1994 Group of 19 leading research-intensive universities. The Group was established in 1994 to promote excellence in university research and teaching. Each member undertakes diverse and high-quality research, while ensuring excellent levels of teaching and student experience.

http://www.1994group.ac.uk

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June 2, 2010

Pfizer And Epocrates Partner To Give Healthcare Providers Access To Medical Information Specialists For Medication Questions

Filed under: Press Releases — Tags: Clinical, epocrates, healthcare, mobile drug reference, nyse:pfe, Pfizer, Resources — The Editor @ 9:18 pm

NEW YORK, - June 2, 2010 (CRWE NEWSWIRE) - Pfizer Inc. (NYSE:PFE - News) and Epocrates, Inc., today announced a collaboration to give healthcare providers (HCPs) mobile access to the Pfizer Medical Information Group to obtain scientific answers to their product questions or to report an adverse event. For the first time, clinicians can make direct contact through the Epocrates drug reference app on their iPhone® device to pharmaceutical manufacturers and immediately apply findings to patient care. Pfizer is enabling easy, direct access to its Medical Information services, via the Epocrates channel, in an effort to enhance the safe and effective use of its medicines, and help improve the quality of patient care.

(Photo: http://www.newscom.com/cgi-bin/prnh/20100602/NY14104-a)

(Photo: http://www.newscom.com/cgi-bin/prnh/20100602/NY14104-b)

(Logo: http://www.newscom.com/cgi-bin/prnh/20100416/PFIZERLOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20100602/NY14104LOGO-c)

“Contact Pfizer” is now a feature available in the Epocrates drug profiles of approximately 40 Pfizer products. By providing easy access directly to the manufacturer, this feature provides Epocrates’ users the option for immediate phone access to Pfizer Medical Information specialists to obtain scientific information about the company’s medications and report adverse reactions. Additionally, healthcare providers will soon have the option to email Pfizer Medical Information for select Pfizer products.

“Healthcare providers have told us they would like direct access to our medical specialists so they can communicate with us in an open, unbiased manner,” said Freda C. Lewis-Hall, M.D., FAPA, senior vice president and chief medical officer at Pfizer. “They expect rapid and tailored scientific responses to their medical questions about our drugs. Our hope is that the introduction of this new and innovative feature on Epocrates enables doctors and other providers to enhance the care they can provide to their patients using Pfizer medicines.”

According to Manhattan Research, 72 percent of doctors currently own smartphones; a number that is expected to increase to four out of five doctors by 2012. One of their primary uses is to look up prescription drug information at the point of patient care. Epocrates is the leader in the mobile drug reference and decision support space. More than 950,000 healthcare professionals, including more than 40 percent of U.S. physicians, actively use Epocrates products, commonly on mobile devices such as iPhone, BlackBerry®, Android™ and Palm®.

“Epocrates is committed to providing healthcare providers with the resources they need to make the best clinical decisions for their patients at the point of care,” said Rose Crane, chief executive officer at Epocrates. “It is at this ‘moment of truth’ physicians may have a question only the manufacturer can answer. We are the only company in a position to facilitate that direct link, and significantly advance communication between a manufacturer such as Pfizer and our strong network of HCPs.”

The “Contact Manufacturer” feature is initially available to iPhone and iPod touch® device users of the Epocrates application, which includes more than 150,000, or nearly 25 percent, of U.S. doctors. Epocrates will work to expand the feature to other mobile platforms as its impact on patient care is demonstrated. As the first company to utilize “Contact Manufacturer,” Pfizer helped support the concept and design to ensure the tool was developed to optimally manage physician queries.

About Epocrates, Inc.

Epocrates is a leading provider of clinical information and decision support tools to healthcare professionals. Epocrates currently has more than 950,000 healthcare professionals, including 40 percent of U.S. physicians and medical students, in its active network. The company’s clinical products and services enable healthcare professionals to make more informed medical decisions, reduce medical errors and practice more efficiently. For more information about Epocrates, please visit www.epocrates.com/company.

Pfizer Inc: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

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