16 August, 2009

Glaxo Smith Klein.

مقر غلاكسو سميث كلاين في غرب لندن



Glaxo Smith Klein.

بدء برنامج من التجارب السريرية على لقاح لأنفلونزا الخنازير


إنتاج اللقاح لندن/ أعلنت شركة غلاكسو سميث كلاين البريطانية، إنها بدأت برنامجها من التجارب السريرية على اللقاح الذي أنتجته لفيروس ايه (اتش1ان1) المسبب لأنفلونزا الخنازير.
وأعلنت الشركة في بيان، أن التجربة الأولى في سلسلة من 16 تجربة انطلقت هذا الأسبوع في ألمانيا، وترمي التجربة إلى تحليل الفعالية والقوة ومعايير أخرى في اللقاح الذي تتم تجربته على 128 شخصا بين ال18 وال60 من العمر، كما ستجري تجارب أخرى لاحقا في دول مختلفة.وأضاف المختبر أن البيانات الأولى التي ستسلم إلى السلطات الصحية يفترض أن تتوافر في سبتمبر، ويفترض أن تبدأ التجارب الأخرى بسرعة، وستجرى ثمان منها على بالغين، وخمس على أطفال، وستجرى تجربتان على متقدمين في السن.

لندن (ا ف ب) - اعلنت شركة غلاكسو سميث كلاين البريطانية الجمعة انها بدأت برنامجها من التجارب السريرية على اللقاح الذي انتجته لفيروس ايه(اتش1ان1) المسبب لانفلونزا الخنازير.
واعلنت الشركة في بيان ان التجربة الاولى في سلسلة من 16 تجربة انطلقت هذا الاسبوع في المانيا. وترمي التجربة الى تحليل الفعالية والقوة ومعايير اخرى في اللقاح الذي تتم تجربته على 128 شخصا بين ال18 وال60 من العمر. كما ستجري تجارب اخرى لاحقا في دول مختلفة.
واضاف المختبر ان "البيانات الاولى التي ستسلم الى السلطات الصحية يفترض ان تتوافر في ايلول/سبتمبر".
ويفترض ان تبدأ التجارب الاخرى "بسرعة". وستجرى ثمان منها على بالغين، وخمس على اطفال (بمن فيهم اطفال صغار). وستجرى تجربتان على متقدمين في السن.
وقال توماس بروير سمؤول التجارب السريرية في جناح اللقاحات في غلاكسو سميث كلاين حول العالم ان الشركة "تحرز تقدما ملحوظا في تطوير لقاح مضاد للوباء. وانتهى اختيار المشاركين في التجربة السريرية الاولى، وستجري الشركة بالاجمال 16 تجربة على اكثر من تسعة الاف شخص في اوروبا وكندا والولايات المتحدة".
وفي آخر مستجدات تفشي الفيروس احصت البرتغال خلال الاربع والعشرين ساعة الاخيرة 177 اصابة جديدة ما يشكل رقما قياسيا للاصابات في يوم واحد بحسب بيان اصدرته الجمعة وزارة الصحة.
اما كوريا الجنوبية فقد سجلت اول وفاة بالانفلونزا لمواطن كوري جنوبي في الخمسينات من عمره كان عائدا من رحلة الى تايلاند.
وفي اسبانيا اعلنت وزارة الصحة الجمعة وفاة امرأة حامل في كاستيون من جراء مضاعفات انفلونزا الخنازير، لتصبح هذه حالة الوفاة الحادية عشر بسبب فيروس أ(اتش1 ان1). واوضحت الوزارة ان الجهات الطبية ابلغتها عن "وفاة امرأة حامل (31 سنة) من جراء مضاعفات مرتبطة بفيروس أ(اتش1 ان1)".
وظهر هذا الفيروس في اوخر اذار/مارس وادى الى وفاة اكثر من 1400 شخص حتى الان. وكانت منظمة الصحة العالمية قد اعلنت
ان العالم يواجه وباء في 11 حزيران/يونيو.
H1N1 influenza: responding to a pandemic
As H1N1 flu continues to make headlines across the world, GlaxoSmithKline is responding to the flu pandemic.
It seems like flu has hardly been out of the headlines for the last three or so years. During 2006 the world was put on alert as cases of avian (H5N1) influenza were seen in the Middle East and South East Asia causing illness and deaths in about 14 countries.
The reality is that we are used to outbreaks of flu every winter. So-called seasonal flu is a serious condition especially for those who are susceptible or weakened by other illnesses or old age.
Each year flu vaccine manufacturers create a vaccine that helps to protect against the most likely strains of seasonal flu and this is usually given to people at risk before or at the beginning of the annual flu season.
For many, a seasonal flu vaccine reduces the worry of catching flu, but what has made the headlines during 2009 is a different type of flu.
Swine flu and influenza A (H1N1)Swine flu is a strain of flu that normally affects pigs. The strain that has been in the news during 2009 is called influenza A (H1N1) and first came to the attention of doctors when an outbreak started in Mexico during April 2009.
Scientists believe that the influenza A (H1N1) virus mutated whilst in pigs into a form that affects humans, so swine flu is not generally accepted as an appropriate name for the current outbreak of flu.
Since the outbreak of influenza A (H1N1) in Mexico, the virus has spread around the world with cases reported in humans in the European Union, North and South America, South East Asia and Australasia. By 8 July 2009, cases of influenza A (H1N1) in humans were reported by the World Health Organization (WHO) in 122 countries with over 94,500 cases in total.
Although the virus passed originally from pigs to humans, it’s reassuring to know that WHO says there is no evidence that influenza A (H1N1) can be caught from eating well-cooked pork.

20th century flu pandemics
1918 – Spanish flu was an H1N1 virus and affected some 40% of the world’s population at the end of the First World War. It is estimated that more than 40 million people died worldwide.
1957 – Asian flu was an H2N2 virus that is estimated that about two million people died, although the availability of a vaccine reduced the number of deaths significantly.
1968 – Hong Kong flu was an H3N2 virus that is estimated that about one million people died, mostly elderly, people worldwide.

Human to human: anatomy of an influenza A (H1N1) pandemicThe fact that influenza A (H1N1) flu has already transferred from pigs to humans was of concern to scientists but what is of greater concern is that it now can pass from human to human.
In April, when the evidence of human transmission was confirmed, WHO raised the worldwide flu alert level from four to five, one level away from full pandemic.
Level five was reached after evidence of significant human to human transfer of the virus. The increase to level six on 12 June 2009 was made because the virus had already shown efficient spread within a population for a sustained period.
Until now influenza A (H1N1) mainly causes moderate illness. WHO says that most people who catch influenza A (H1N1) will recover without needing medicines and will make a full recovery. A person should seek medical care if they experience shortness of breath or difficulty breathing, or if a fever continues more than three days.
GSK is responding to the influenza A (H1N1) pandemicVarious medicines can be used to prevent and treat flu – these include vaccines and anti-virals.
GSK is responding to the influenza A (H1N1) pandemic by investing in the development of vaccines for the influenza A (H1N1) strain of flu and the increased production of the anti-viral Relenza through its own manufacturing facilities and through partnerships with other companies.
Preventative measures taken by governments may include vaccination, to prevent people from catching flu. This is why some governments have chosen to purchase the influenza A (H1N1) vaccine in development. Another preventative measure is the use of anti-viral medicines, which some governments have already been stockpiling for several years.
To meet this need, pharmaceutical companies such as GSK have quickly started development and production of the new influenza vaccine and increased the production of antiviral medicines.

The World Bank has estimated that a severe flu pandemic could cost the world around $3 trillion**

GSK is investing heavily in increasing capacity to help governments and other organisations to respond to a global influenza pandemic. That includes investing to conduct research and expand production capacity for both Relenza. The company has added several manufacturing lines to meet increased demand for Relenza, and as a result, has already supplied significant quantities of Relenza to meet stockpile orders.
A vaccine to help to protect against influenza A (H1N1)As a result of the outbreak of H5N1 flu in 2006 GSK set in place the development of a vaccine that could help to protect against global flu pandemics. In 2008, the company developed the first pre-pandemic vaccine as well as a candidate vaccine to help to protect against H5N1 flu.
During the recent influenza A (H1N1) outbreak, GSK has been in continuous discussions with WHO, the US Centers for Disease Control and Prevention, the US Department of Health and Human Services and the European Centre for Disease Prevention and Control to gain a better understanding of the new influenza A (H1N1) strain.
The company has working with these authorities, as requested, to help them develop estimates for manufacturing capability, timing of possible production and understand the benefit of using adjuvant technology in production of a potential pandemic vaccine.
In June 2009, GSK began the development a potential vaccine against the influenza A (H1N1) strain of the flu after WHO and other public health authorities made recommendations for composition of the vaccine.
What you can doThere are several things that you can do to reduce the risk of catching seasonal (and other forms of) flu:
Avoid touching your mouth and nose
Clean hands thoroughly with soap and water, or cleanse them with an alcohol-based hand rub on a regular basis (especially if touching the mouth and nose, or surfaces that are potentially contaminated)
Avoid close contact with people who might be ill
Reduce the time spent in crowded settings if possible
Improve airflow in your living space by opening windows
Practise good health habits including adequate sleep, eating nutritious food, and keeping physically active
The latest information on flu can be found on the World Health Organization’s website.
** World Bank website
Important Safety Information on Relenza
Some patients have had bronchospasm (wheezing) or serious breathing problems when they used Relenza. Many but not all of these patients had previous asthma or chronic obstructive pulmonary disease. Relenza has not been shown to shorten the duration of influenza in people with these diseases. Because of the risk of side effects and because it has not been shown to help them, Relenza is not recommended for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease.
If you develop worsening respiratory symptoms such as wheezing or shortness of breath, stop using Relenza and contact your healthcare provider right away.
If you have chronic respiratory disease such as asthma and chronic obstructive pulmonary disease and your healthcare provider has prescribed Relenza, you should have a fast-acting, inhaled bronchodilator available for your use. If you are scheduled to use an inhaled bronchodilator at the same time as Relenza, use the inhaled bronchodilator before using Relenza.
Other kinds of infections can appear like influenza or occur along with influenza, and need different kinds of treatment. Contact your healthcare provider if you feel worse or develop new symptoms during or after treatment, or if your influenza symptoms do not start to get better.
In studies, the most common side effects with Relenza have been headaches; diarrhea; nausea; vomiting; nasal irritation; bronchitis; cough; sinusitis; ear, nose, and throat infections; and dizziness. Other side effects that have been reported, but were not as common, include rashes and allergic reactions, some of which were severe.
This list of side effects is not complete. Your healthcare provider or pharmacist can discuss with you a more complete list of possible side effects with Relenza. Talk to your healthcare provider promptly about any side effects you have.

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