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GARDASIL® is First Cervical Cancer Vaccine to Receive WHO Pre-qualification

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Cervical cancer is the second most common cancer among women worldwide. Almost 80 percent of cervical cancer cases occur in developing countries.
Human papillomavirus (HPV) is estimated to cause about half a million new cervical cancer cases every year, with a majority affecting women in developing countries. For most women, HPV goes away on its own, however, for some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer.
HPV types 16 and 18 cause approximately 70 percent of cervical cancer cases. Not all vulvar and vaginal cancers are caused by HPV and the exact number of cases caused by HPV types 16 and 18 is unknown. However, it is estimated that HPV types 16 and 18 account for 40-50 percent of vulvar cancers and about 70 percent of vaginal cancer. Genital warts are abnormal skin growths caused by HPV, particularly types 6 and 11, which cause more than 90 percent of genital warts.

Now for some good news:

GARDASIL®
[Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], Merck Sharp & Dohme’s cervical cancer vaccine, has been awarded World Health Organization (WHO) pre-qualification. GARDASIL® is the first cervical cancer vaccine to receive WHO pre-qualification.

WHO pre-qualification means that GARDASIL® is now eligible for procurement by the United Nations Children’s Fund (UNICEF) and other United Nations (UN) agencies including the Pan American Health Organization (PAHO), for use in national immunization programs.

“We recognize the significant impact cervical cancer has on women and families, especially in the developing world, which is why Merck Sharp & Dohme is committed to improving access to innovative vaccines like GARDASIL®,” said Margaret G. McGlynn, president, Merck Sharp & Dohme Vaccines and Infectious Diseases. “WHO pre-qualification is an important step in helping to ensure greater global access to GARDASIL® and to help protect against cervical cancer and other HPV-related diseases caused by HPV types 6, 11, 16 and 18 in more countries throughout the world.”

WHO pre-qualification aims to ensure that vaccines meet WHO standards of quality, safety and efficacy, which in conjunction with other criteria, is used by the UN and other agencies to make purchasing decisions.

“Cervical cancer is a significant burden in developing countries. WHO pre-qualification of an HPV vaccine signifies a move to help protect young women and improve access to better health care, particularly in the poorest countries,” comments Graça Machel, Founder and President of the Foundation for Community Development (FDC), Mozambique and a passionate advocate for women’s health.

About GARDASIL®

GARDASIL® is currently indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical cancers, vulvar and vaginal pre-cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancer cases and HPV types 6 and 11 are responsible for approximately 90 percent of genital warts and about 10 percent of low-grade cervical changes/lesions/dysplasias.

GARDASIL® is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL®

About access to GARDASIL® in the developing world

WHO pre-qualification is a significant part of Merck Sharp & Dohme’s approach to accelerating access to GARDASIL® in the developing world through four key pillars:

  • Innovation
  • Partnerships
  • Pricing
  • Implementation

This development follows the recent WHO position paper on the use of HPV vaccines.

Merck Sharp & Dohme will offer GARDASIL® to the public sectors of GAVI-eligible countries at a price at which we do not profit. Additionally, Merck Sharp & Dohme is exploring several ways to further reduce product cost for the developing world, including manufacturing efficiencies and reduction of royalties paid out to licensors on GARDASIL® doses sold in the developing world.

In 2007, Merck Sharp & Dohme made a commitment to donate at least 3 million doses of GARDASIL® over five years to help address the problem of HPV infection in under-resourced communities through the GARDASIL® Access Program which is managed by Axios Healthcare Development. In February 2009, the first doses of the donated GARDASIL® were shipped.

Additionally, Merck Sharp & Dohme is partnering with PATH, an international non-profit organization, to conduct demonstration projects of GARDASIL® in the developing world by providing vaccine and technical support at no cost. These demonstration projects are designed to support the accelerated availability of cervical cancer vaccines in the world’s least-developed countries. The projects are complete in Peru and ongoing in Vietnam and India.

Merck Sharp & Dohme is also sharing clinical data on GARDASIL®, HPV epidemiology and cervical cancer rates from studies done in 41 countries and more than 38,000 patients with health authorities, governments, non-governmental organizations and physicians around the world.

Additional important information about GARDASIL®

  • The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening.
    Women who receive GARDASIL® should continue to undergo cervical cancer screening.
  • GARDASIL® is not recommended for use in pregnant women.
  • GARDASIL® is not intended to be used for treatment of active genital warts, cervical, vaginal and vulvar pre-cancers, cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).
  • GARDASIL® has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL® has not been shown to protect against diseases due to HPV types not contained in the vaccine.
  • Not all vulvar and vaginal cancers are caused by HPV and GARDASIL® protects only against those vulvar and vaginal pre-cancers caused by HPV 16 and 18. Vaccination with GARDASIL® may not result in protection in all vaccine recipients.
    In clinical studies for GARDASIL®, headache was the most commonly reported adverse reaction. Common adverse reactions that were observed at a frequency of at least 1 percent among recipients of GARDASIL® and also greater than those observed among recipients of control group, respectively, were pain, swelling, erythema, fever, nausea, pruritis, dizziness and bruising. In addition, syncope has been reported following vaccination with GARDASIL®, sometimes resulting in falling with injury: observation for 15 minutes after administration is recommended.

Dosage and administration for GARDASIL®

GARDASIL® is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL® should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

GARDASIL® is approved in 111 countries

GARDASIL® has been approved in 111 countries, 23 of which are GAVI-eligible, and additional applications are currently under review with regulatory agencies in more countries around the world.

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DesignTech Systems to provide solutions to Nairobi’s Coptic Hospital

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DesignTech Systems bags ERP order from Kenya Hospital and two clinical units

 


DesignTech Systems Limited, leading Product Lifecycle Management, engineering design firm and healthcare solution provider, has bagged an international contract. After delivering its Enterprise Resource Planning (ERP) solution to over a dozen hospitals across India, DesignTech has now got a contract for its ERP installation in one of the largest private hospitals in Kenya’s capital Nairobi. This is DesignTech’s first international project which is to be installed in May.

Mr Vikas Khanvelkar managing director DesignTech Systems Limited said “We have received an order from Coptic Hospital in Nairobi to install the ERP solution developed by our healthcare team. Coptic Hospital is a 250-bed specialty hospital. “

The ERP will also be installed at the two small clinical units run by the group. Asclepius, the ERP developed by DesignTech is a comprehensive hospital management system that takes care of the entire operation within a hospital set-up. Right from patient’s registration to blood bank details and billing procedure, all processes are integrated in the 42-module software

“We could win over the competition because we were able to deliver state-of-the-art technology such as ‘n’ level distributed architecture through our products; thus not only were we able to deliver performance but make sure to protect customer’s cost of ownership for years to come” said Mr. Sachin Chougule, Director, DesignTech Systems.

Asclepius is a comprehensive range of solutions that not only manages and provides all the data but also configures and executes workflows. Asclepius is scalable to meet the needs of small, big and growing clinics and medicals hospitals. DesignTech Systems Limited is also in talks with leading hospitals in other African countries for the same project.

For more information visit:

http://www.dt-healthcare.com

www.designtechsys.com

 


Written by sreelakshmi

25 May, 2009 at 8:12 pm

iSOFT wins US$ 3.54m deal in England for a hospital information system

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iSOFT, an IBA Health Group Company, today announced that it has won a contract for a hospital information system with a National Health Service (NHS) trust in southern England worth £2.4 million (US$3.54m) over five years.

The contract with Heatherwood and Wexham Park Hospitals NHS Foundation Trust is for iSOFT’s i.Patient Manager (i.PM) PAS and a technical refresh of an existing iSOFT clinical solution, i.Clinical Manager (i.CM). i.PM is replacing an outdated third-party system.

The trust elected to contract directly with iSOFT for a replacement PAS instead of waiting for a solution under England’s National Programme for IT. This is one of the first major deals in the Southern Cluster, which was formerly serviced by Fujitsu.

Jonathan Pearce, the Trust’s Director of Infrastructure, said: “We are delighted to be working with iSOFT on this very important programme for Heatherwood and Wexham Park Hospitals NHS Foundation Trust. We already have a strong working relationship with iSOFT as we already use its clinical information system, i.CM. We very much value our partnership with iSOFT and look forward to strengthening this and working with the company to deliver the new PAS solution to the trust.”

Adrian Stevens, Managing Director of iSOFT UK and Ireland, said: “i.PM is a highly robust and proven solution from a company with an established pedigree in the NHS.”

“The seamless integration with i.CM provides a complete patient and clinical management solution to better manage appointments, improve efficiency and reduce waiting times. It also provides a foundation for a smooth transition to iSOFT’s next generation of healthcare solutions. This underlines our position as the leading provider of healthcare solutions to the NHS,” Stevens said.

The trust serves a population of more than 450,000 in six locations: Wexham Park Hospital near Slough, Heatherwood Hospital in Ascot, and hospitals and outpatient clinics in Bracknell, Maidenhead, the Chalfonts, and Windsor.

iSOFT wins US$ 1.0 million deal for a hospital information system in Libya‏

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iSOFT, an IBA Health Group Company, today announced that its Middle East and Africa division won a two-year deal to implement its hospital information system and a LabCentre solution at Al Khadra Hospital in Tripoli, Libya. The agreement is worth A$ 1.4 million (US$ 1.0 million).

iSOFT’s Executive Chairman & CEO, Gary Cohen, said: “This deal opens a new market for us in Northern Africa and expands our global footprint to 37 countries. Together with our recent agreements in Honduras and Mexico, this deal demonstrates our growing international influence of iSOFT as one of the world’s biggest health IT companies. It also proves that there is an untapped stream of potential growth opportunities for businesses with a global outlook.”

iSOFT’s eHIS solution will be implemented at Al Khadra private hospital in two phases in partnership with Alshada Pharmaceutical & Medical Equipment in Tripoli. Al Khadra, with more than 580 beds and 700 staff, has been a pioneer in many surgical procedures in Libya, such as urology, endoscopic and laparoscopic surgery. eHIS will provide point-of-care access to patient medical records to inform clinical decisions and so speed diagnoses and improve the quality of care. Integrated with the iSOFT LabCentre laboratory information system, clinical staff can request pathology tests and review and analyse results online. Faster turnaround of pathology tests again helps doctors make timely clinical decisions and improve treatment.

Tobacco addiction is a major cause of Tuberculosis!

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Half of all male deaths by tuberculosis in India a result of smoking

“I Am Stopping TB”this is the slogan that has been adopted worldwide for the World TB Day, 2009. “I Am Stopping TB” is the start of a two-year campaign internationally in support for control of TB. In keeping with the theme, a significant effort should be made to highlight the fact that a significant amount of TB deaths in India are caused by smoking – most starkly, including half the amount of males who succumb to TB in the country. Almost 200,000 people a year in India die from tuberculosis because they smoked, and half the smokers killed by TB are still only in their thirties, forties or early fifties when they die. 

On the occasion of World TB Day (24th March 2009), Dr.P.C.Gupta, Director, Healis Sekhsaria Institute for Public Health, said “Smokers expose themselves to a plethora of diseases and illnesses, and as research and studies show, Tuberculosis is one of the most life threatening diseases caused by tobacco.
We therefore urgently need to take extensive measures to increase social awareness about tobacco as a cardinal cause of tuberculosis and make an effort to educate society about the dangers of the disease.”

Studies have shown that half the male tuberculosis deaths in India are caused by smoking, and three quarters of the smokers become ill with tuberculosis (TB) through smoking. A major study led by the Epidemiological Research Center in Chennai, India and funded by the UK Medical Research Council and Cancer Research UK have come up with detailed results on tobacco being a major cause of tuberculosis. The study found that in India male smokers are about four times as likely to become ill with TB as non-smokers, and consequently four times as likely to die from the disease. The study also showed the smokers had higher death rates from heart disease and from various types of cancer. In total, about a quarter of the smokers studied were killed at ages 25-69 by their habit, those killed at these ages losing, on average, 20 years of life.

Tuberculosis still causes about 1.6 million deaths a year worldwide, including more than a million in Asia, 400,000 in Africa and 100,000 in the Americas and Europe, and in some countries it is now becoming more common.

 

New business from The British Midlands

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Yesterday in New Delhi a business mission from England’s British Midlands region was welcomed by one of leading real estate companies, Vipul Ltd. The British Midlands, a UK government-funded organisation, that comprises two of the nine UK-based regional development agencies East Midlands Development Agency (EMDA) and Advantage West Midlands (AWM) who work together to offer support to all international businesses looking to invest in the British Midlands region. Mr. Anil Aggarwal, Director, Vipul Ltd. was Chief Guest at the inauguration of the mission as it heads for the Punjab.

The British High Commission supports this group of business people who will be meeting partners in Chandigarh, Ludhiana, Jallandhar and Amritsar in a week of busy business meetings, with support from the CII and UK Trade and Investment.

The key theme of the missioners is growth through delivery of shared visions between the Punjab and the British Midlands region of England that matches the Punjab in Agri-business, Engineering, Education and research. The British Midlands region hosts nine leading Universities and many excellent colleges – two participating in this mission.

The region is keen to develop partnerships and share its diverse advanced technologies in space, transport – from rail to motor racing, waste treatment, bio and life sciences and technical textiles. It is also host to high quality services, as wide ranging as quality assurance, innovative design education, ICT, skills assessment, and freight support services. The UK’s most prestigious luxury brand in table and giftware, Royal Crown Derby, is also part of this mission.

The Universities in the Punjab have been approached by the British High Commission to match those in the British Midlands, and this mission will start the formal partnering with the Punjab, identifying shared strategies and opportunities to create new joint research, new courses and fresh content that will start to develop.

The mission is led by Helen Deas, who set up the East Midlands India Business Bureau for England’s East Midlands Development Agency (emda) after completing three years as Deputy Head of Mission and Head of trade and investment Western India in the British Deputy High Commission in Mumbai.

Thanking Vipul Ltd. for their support she said “I am certain that two States in India are natural partners for the British Midlands’ region. This visit to the Punjab will result in business and future new developments for the mutual benefit of our educational establishments, businesses and people. I am delighted to have witnessed India’s innovation and growth. Whatever world problems there are, our regions have so much to gain that they need to understand more about each other now. The British Midlands India Business Bureau will offer free help to bring our businesses and skills programmes together, with support for Punjabi senior business visitors, looking to visit or establish, as well as British Midlands’ firms doing the same in the Punjab. In addition to many Punjabi speakers is the region, we also are proud to be home to the excellent entrepreneurial example of Dr Nath Puri, of Purico and the Puri Foundation, now President of the Nottinghamshire Cricket Club.”

Mr. Anil Aggarwal met ten organizations on this British Midlands Regional Government funded mission and will be supporting their meetings in Ludhiana. Talking at the meet he said “We welcome this interest from the businesses from this East Midlands India Business Bureau supported mission. This mission will not only improve the bilateral relations between India and the UK but will also provide us a platform to further enhance our business opportunities. We are glad that the Punjab is on their priority list as it offers huge growth potential for mutual business development. We are looking forward to working with them and to widening our business scope.”

The British Midlands India Business Bureau plans a further University mission to the Punjab and to Gujarat later this year.

For further details:
http://www.thebritishmidlands.com



Written by sreelakshmi

3 March, 2009 at 10:44 pm

Air India Express Enlists CyberSource Online Fraud Solution

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CyberSource Ltd., the UK-based subsidiary of CyberSource Corporation, today announced that its Decision Manager anti-fraud solution has been selected by Air India Express. Decision Manager, designed to help companies like Air India Express automate and safeguard its online ticketing, provides access to over 150 global validation tests to screen for fraud and determine in real time whether online transactions should be accepted, rejected, or marked for further review.

Dr. Akif Khan,
head of client and technical services at CyberSource Ltd., said, “Air India Express is carving out new market opportunities in the Asian airline business, and we are pleased to assist them in risk management. The work we are doing with Air India Express furthers our experience in the Indian marketplace and in the global travel sector, both of which have been focus areas for CyberSource.”

Air India Express is India’s first international airline to offer budget travel. The carrier flies to 14 key international destinations including Dubai, Abu Dhabi, Singapore and Bahrain, and also operates a domestic service between major Indian cities.

“Our rapid growth dictates a robust solution that can not only identify potentially fraudulent activity but also minimises the burden on manual review staff,” said Harish Pai,
finance head, Air India Express. “CyberSource’s considerable experience in the Indian online environment and in the travel sector was also a factor in our selection process.”

How Decision Manager works

Decision Manager features an easy-to-use interface which allows fraud management staff to create rules and manage acceptance criteria for online orders.  Based on rules Air India Express defines, Decision Manager automatically determines the appropriate disposition of incoming orders—accept, reject, or review. Orders suspended for review are held in a case management queue for fast examination and disposition using Decision Manager’s sophisticated case management system. Rules can be tested without risk to determine their effectiveness and quickly modified to adapt to changing order patterns. A complete array of process analytics further helps address the accuracy and efficiency of the fraud management process.

For more information on CyberSource’s Decision Manager, see: http://cybersource.co.uk/products_services/risk_management/.