Month: August 2011

Daiichi Sankyo launches Lixiana ® (edoxabán) in Japan for the prevention of venous thromboembolism after major orthopedic surgery

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Daiichi Sankyo launches Lixiana ® (edoxabán) in Japan for prevention of thromboembolism venous after major orthopedic surgery

is the first oral inhibitor of factor Xa that puts at the disposal of Japanese patients

Tokyo, 2011-August Daiichi Sankyo Co. Ltd. is pleased to announce the launch in Japan of Lixiana ® (edoxabán). The arrival on the market of the medicinal product takes place after the approval of commercialization of the Ministry of health, labour and welfare Japanese for submissions of edoxabán in tablets of 15 mg and 30 mg, which took place in April of 20111, and represents the first time in edoxabán is placed at the disposal of patients.

Edoxabán is an oral anticoagulant of daily single notes that specific, reversible and directly inhibits the Xa clotting factor. The adoption of marketing has been based on the results of clinical studies on edoxabán for the prevention of venous thromboembolism in patients following total hip or knee arthroplasty or hip fracture surgery.

“ Japan release is the world debut of this drug, which is great news for all patients who require prevention against venous thromboembolism after major orthopedic surgery ”, says Joji Nakayama, Chairman and CEO of Daiichi Sankyo, adds: “ Edoxabán has shown a solid clinical efficacy in the estudios2(3) in this type of patient. In addition, its predictable pharmacokinetic and pharmacodynamic profile allows his administration through a convenient single daily dose ”.

Edoxabán clinical development programme includes various indications which include the prevention of stroke in patients with atrial fibrillation and the treatment and prevention of recurrent venous thromboembolism.

Two studies phase III on edoxabán have currently being developed. The first of these is ENGAGE AF-TIMI 484, a multinational trial, randomized and blind that analyzes the efficacy and safety of the medicinal product in the prevention of stroke and events systemic Embolic in patients with atrial fibrillation. Research involves more than 21,000 patients with atrial fibrillation from 46 countries, which makes it the largest study for this indication worldwide to date. On the other hand, Daiichi Sankyo is completing the recruitment of patients for study HOKUSAI VTE5, another test phase III multinational, randomized and double blind. He participate in 7,500 patients of 450 centres representatives of 40 countries around the world, so it is also the study with greater number of patients to date on treatment and prevention of recurrent venous thromboembolism.

About venous thromboembolism

Venous thromboembolism refers to the generation of clots and subsequent blockage of a vein or pulmonary artery. Deep venous thrombosis and pulmonary embolism are types of venous thromboembolism. Venous thrombosis is the formation of a blood clot in the deep veins of the legs and the pelvis. Pulmonary embolism is caused when a clot reaches the lungs and is housed in the pulmonary arteries.

About edoxabán

Edoxabán is an oral anticoagulant of daily unique decision-making which directly inhibits factor Xa, a relevant factor in the process of blood clotting. Edoxabán is currently available only in Japan for the prevention of venous thromboembolism in patients following total hip or knee arthroplasty or fracture of cadera1 surgery. Daiichi Sankyo continues the development of edoxabán at the global level as a potential new treatment for the prevention of stroke in patients with atrial fibrillation and the treatment and prevention of recurrent venous thromboembolism. Daiichi Sankyo has more than 25 years of experience in research of inhibition of factor Xa and was the first company to study this type of molecules in humans.

About Daiichi Sankyo

Daiichi Sankyo group is dedicated to the research and supply of innovative pharmaceutical products, both in mature markets as emerging, they face various medical needs of patients who are not yet covered. The company was created in 2005 through the merger of two companies of Japanese tradition and Daiichi Sankyo. Daiichi Sankyo is one of the 20 leading pharmaceutical companies in the world. In addition to the maintenance of its drugs for hypertension, Hyperlipidemia, and bacterial infections, the group is focused on the development of treatments for disorders thrombotic research in Oncology as well as new therapies in the cardiovascular area and metabolism. On the other hand, Daiichi Sankyo group has created a “ hybrid business model “, which responds to the diversity of the market and customer seeking to optimize the opportunities for growth in the entire value chain.

The company’s global headquarters is in Tokyo. Its European base, Daiichi Sankyo Europe, is in Munich and has subsidiaries in 12 European countries as well as a plant of global manufacturing in Pfaffenhofen (Germany).

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A new model predicts how the drugs affect the environment.

A new model predicts how the drugs affect the environment.

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A new model predicts how the drugs affect the environment.

article has been published in ‘ Water Air and Soil Pollution ’.

-The majority of synthetic chemical products incorporated in goods end his unbroken life cycle in the environment. To the risks to the environment and human health, researchers from the Autonomous University of Barcelona (UAB) have developed a new tool to predict the fate of current and future drugs effectively,

Spain, 2011-August thousands of pharmaceuticals, most diverse and consumed, they are “ partially ” metabolized by the body. Those drugs that remain unchanged reach wastewater treated in sewage treatment plants, which are not always designed to remove synthetic organic compounds.

“ Sometimes even certain substrates can revert to the original drug within the same plant and increase the concentration of drug in the output of the effluent from the plant, as it is the case of carbamazepine (anticonvulsant drug psicótropo) ”, explains Xavier Domenech, co-author and researcher at the Department of chemistry of the UAB


a wide variety of drugs which may be harmful to wildlife reach environment.

the result is that wild. reach a wide variety of drugs which may be harmful to the life environment “ concern increases when we talk about the purification of water for human consumption, where more and more is detected the presence of a cocktail of drugs to low concentration (nanograms per liter), the effect of which in the long run it is not known ”, says Domenech.

Determine the effect of the drug

The study, published in Water Air and Soil Pollution, has allowed to develop a new tool that determines the possibility of drugs end up in the environment and what concentration, thus fulfilling the obligation of the European Medicines Agency (EMEA, for its acronym in English) to assess the environmental risks of new drugs that want to commercialize.

The new tool, developed by Marc Ribera, lead author of the research, uses a few properties physico-chemical and the rate of consumption of drugs in Spain between 1999 and 2006 to determine its environmental performance. Tested drugs that are the most consumed in Spain (more than 1 mg of active substance per person per year) have been among many others, ibuprofen, diazepam, naproxen, omeprazole, paracetamol.

To validate the model, the team of researchers compared the results of the prediction of the model in water, with values measured by other authors in rivers and lakes. “ Applied model predicts good experimental data and can become a good model of prediction for the assessment of environmental risks of current drugs and those who intend to be marketed ”, concludes Domenech.

bibliographic references:

Domenech, Xavier; Ribera, Marc; PEAR, José. “ Assessment of Pharmaceuticals Fate in a Model Environment ” Water Air and Soil Pollution 218 (1 – 4): 413-422, June 2011.

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GlaxoSmithKline and Human Genome Sciences receive European authorisation for Benlysta r (belimumab).

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GlaxoSmithKline and Human Genome Sciences receive European authorisation for Benlysta r (belimumab).

Spain, August of 2011- GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that the European Commission has authorized the marketing of Benlysta ® (belimumab) 10 mg/kg as adjuvant therapy in adult patients with systemic lupus erythematosus (SLE) with autoantibodies positive, with a high degree of disease activity (for example: antiADNdc positive and low complement levels), despite the standard treatment (i).

“ European authorisation of Benlysta represents a significant milestone and we are excited to offer physicians an additional treatment option for treating patients appropriate with this chronic disease ”, said Dr. Tony Hoss, senior Vice President, European Medical Affairs for GSK.

“ GSK and we have committed ourselves to Benlysta available in countries around the world ”, said H. Thosmas Watkins, President and Chief Executive Officer of HGS. “ We are especially proud to have brought forward this medication in Europe, where several important academic research centres have been key in its clinical development ”.

Technical specifications specifies the groups of patients who have not been studied with belimumab, including serious active CNS lupus and lupus nephritis active serious. Therefore, the use of belimumab is not recommended for the treatment of these situations. Belimumab should be used cautiously in co-administration with other targeting B cells or cyclophosphamide treatment, given that it has not been studied in combination with these treatments.

Benlysta (belimumab)

The Food and Drug Administration (FDA) of the United States authorized belimumab on March 9, 2011. GSK and HGS have announced the approval by Health Canada on July 12. There have been applications for authorisation, currently in process of review, Australia, Switzerland, Russia, Brazil, Israel, Singapore, Philippines, Taiwan and Colombia.

Belimumab fact sheet includes detailed recommendations for their use and shall be published in the European public assessment report (EPAR)

collaboration of GSK and HGS

HGS and GSK belimumab being developed within the framework of an agreement for joint development and comarketing this medicine signed in 2006. Under this arrangement, HGS has the responsibility to develop studies in phase III of belimumab with the help of GSK. Companies will share equally the costs of development of the phase III and IV, sales and marketing costs and benefits of any product marketed within the framework of the present agreement.

Benlysta is a registered trademark owned by Human Genome Sciences, Inc., used under license by the Group of companies GlaxoSmithKline.

GlaxoSmithKIine (GSK), one of the leading global research-based pharmaceutical and health care, aims to improve the quality of life of people, making it possible that people have more vitality, feel better and live more time.

GSK Biopharm R & D are investigating new approaches to take advantage of the therapeutic potential of drugs biolis for the benefit of patients with autoimmune diseases.

Human Genome Sciences aims to provide new drugs to people who are fighting against serious diseases.

HGS, Human Genome Sciences and Benlysta are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are property of their respective owners.

Referencia:

(i) GlaxoSmithKline and Human Genome Sciences. Technical data for Benlysta ® 2011

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2nd Hepatology days.

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2nd. Hepatology days

will take place on 3 August, from 14 to 18.30 at Universidad Maimonides 775 Hidalgo headquarters. In addition, throughout the day will be transmitted over the Internet.

Buenos Aires, August of 2011- on 3 August from 14: 00, the “latter days of hepatology”, organized by the Faculty of Health Sciences will be developed in the Maimonides University. The meeting will be held in the Auditorium of the Maimonides University, 775 Hidalgo, Ciudad de Buenos Aires.

Similar to 2010, in the Auditorium of the House of higher studies will address topics such as Viral Hepatitis and other etiologies of HCC: importance of new developments in the histopathological diagnosis treatment, transplants and country: ablation by RF and other techniques, among other topics also will be transmitted over the Internet for all the world.

In the framework of the day, will speak the doctors Bernardo Frider (Head Dept. medicine Hepatology Hospital Argerich), Fernando Bessone (President of the Argentina Association for the study of liver diseases), Oscar Imventarza (Chief of the Hepático transplantation of the Argerich Hospital program), Javier Lendoire (Prof. surgery Deputy – Deputy Chief UBA Hepático transplantation of the Argerich Hospital program)Shigeru Kozima (Chief of the images service of the Argerich Hospital and the CEMIC), Adrián Nervo (oncologist of the Oncology service of the Argerich Hospital and Institute Fleming) and Marcelo lover (medical pathologist service of pathological anatomy of the Argerich Hospital and Hospital Austral).

Given that the hepatocellular carcinoma is related to viral hepatitis in its final stage, and with other etiologies such as alcoholism, diagnosis and treatment of tumor – the 5th most common in the world – should be through a multidisciplinary, being this activity of interest to clinicians approach, hepatólogos, gastroenterologists, radiologists, surgeons, oncologists, and students advanced medicine, among others.

The event will be broadcast live via the Internet (streaming). Please ask for the password by sending an e-mail to secmed@maimonides.edu.

Information and registration (no charge): in Hidalgo 775 (city of Buenos Aires) – Tel. 4905.1113/1101 – or by email to informes@maimonides.edu – www.maimonides.edu

agenda:

14.00 hs – introduction: Dr. Bernardo Frider

1415 hs – Viral Hepatitis and other etiologies of HCC: importance of treatment – Dr. Fernando Bessone

1445 hs – new developments in the histopathological diagnosis: Dr. Marcelo Amante

1515 hs – diagnostic imaging: Dr. Shigeru Kozima

1545 hs – Coffee Break

1545 hs – surgical treatment of HCC: Resection: Dr. Javier Lendoire

1615 hs – Transplant – Dr. Oscar Imventarza

1645 hs – country, radiofrequency ablation and other techniques

1715 hours. – medical treatment of HCC – Dr. Adrián Nervo

1745 hs – final round table: all the panelists

interactive session – treatment of viral hepatitis dialogue with experts – Dres. F. Bessone and B. Frider

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The clinician is launching a unity of functional disorders of the digestive system.

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The clinical launches a unit of disorders functional of the tract digestive

in addition to health care, activity is an important work of research with 19 projects in progress.

-Unit will address a group of diseases that affect 40% of the population

-functional disorders of the digestive system are diseases of which the cause is not known

Spain, August of 2011- the service of digestive of the Hospital Clínico San Carlos, directed by Dr. Manuel Díaz-Rubio, it has launched a drive to the study, treatment and research of functional disorders of the digestive system, a group of chronic digestive problems that affect 40% of the population.

Functional digestive disorders represent a group of diseases of which the cause is not known and attributed to alterations in the control of the neuron or muscle activity that govern the functioning of the digestive tract. These pathologies include the Irritable bowel syndrome, gastroesophageal reflux, functional dyspepsia, chronic constipation, functional abdominal pain syndrome and abdominal distention. The most common is the Irritable bowel syndrome (IBS), a chronic disease that affects more than four million and a half of Spaniards, and it is one of the most frequent causes of consultation to gastroenterologists. Followed in importance by functional dyspepsia, which is a chronic disorder that prevents and hinders the complete digestion, and reflux GERD, a condition in which backward gastric juices containing acid from the stomach into the esophagus and in the most serious cases can lead to cancer.

Social and economic impact

Functional digestive disorders have a significant impact on people with them, because their causes limitations in daily activity, both in their working life and the enjoyment of their leisure activity, with the consequent decline in the quality of life. Coexistence with other problems such as depression, anxiety and chronic stress, which often makes complex treatment of these patients is also frequent. Therefore the aforementioned unit professionals work coordination with specialists in other departments and units of the Hospital.

On the other hand, there are a small number of patients with functional digestive disorders severe requiring specific attention and that are also addressed in this new unit of the Hospital Clínico San Carlos.

The factors that cause these disorders are many, which generally requires to perform a large number of diagnostic tests to be able to introduce appropriate treatment in each case. In addition, occasionally the diagnosis is based on the study of symptoms that they have no detectable alterations in analytical or radiological testing.

Research and teaching work

There are many gaps there in the knowledge of these problems, both as regards their cause in the therapeutic possibilities. Therefore, at the time engaged in the care work, the specialists of this unit have a special concern for raising awareness of these diseases and put at the disposal of patients advances occurring in the treatment. Why are developing various research lines aimed both to study the impact of these problems in the population at the clinic, and the development of new methods for the study of these patients and evaluation of specific instruments to investigate these issues and their impact.

Currently the Clínico San Carlos unit develops 19 research projects; nine of them focused primarily in the area of the reflux GERD and its relationship with food, pregnancy, and obesity as associated factors. It also investigates the Gerd does not respond to conventional treatments, and functional heartburn. A total of 7 projects have been initiated to study the Irritable bowel syndrome, and the other 3 projects are related to chronic constipation.

The teaching work of this unit is of great importance for it professionals that, in addition to train medical residents, organized courses for other specialists in order to address the effective health care models to treat these pathologies.

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Surah Al-Rehman – The Ultimate Free Remedy for Incurable Diseases

(By Listening Only- 20 Minutes Only)

Kindly download the Surah “AL-REHMAN” (recited by Qari Abdul Basit without translation) from here.


Treatment Plan

Just Listen to it three times a day (morning, afternoon, evening) for seven consecutive days using following procedure:-


    Before listening:

  • Close your eyes
  • Feel your self in front of ALLAH Almighty/ God
  • Then listen to it with greater concentration and closed eyes

    When the recitation/ AUDIO is finished:

  • Open your eyes and take half glass of water
  • Close your eyes again and say “ALLAH” three times in your heart with deep affection/ love
  • Then drink the water with closed eyes in three sips

Surah Al-Rehman – The Ultimate Free Remedy for Incurable Diseases

(By Listening Only- 20 Minutes Only)

Kindly download the Surah “AL-REHMAN” (recited by Qari Abdul Basit without translation) from here.


Treatment Plan

Just Listen to it three times a day (morning, afternoon, evening) for seven consecutive days using following procedure:-


    Before listening:

  • Close your eyes
  • Feel your self in front of ALLAH Almighty/ God
  • Then listen to it with greater concentration and closed eyes

    When the recitation/ AUDIO is finished:

  • Open your eyes and take half glass of water
  • Close your eyes again and say “ALLAH” three times in your heart with deep affection/ love
  • Then drink the water with closed eyes in three sips