More than 400 reports of suspected adverse reactions to oseltamivir (Tamiflu)

Over 400 reports of suspected adverse reactions to Tamiflu have been recorded since April this year, figures from the drug safety monitoring body show. Figures due to be published by the Medicines and Healthcare products Regulatory Agency (MHRA) later this week will show that there have been 125 events reported in the past week alone. Between 1 April and 6 August there have been a total of 418 reports of 686 suspected adverse reactions to Tamiflu.
http://www.drugscontrol.org/news.asp?id=4353&hl=More%20than%20400%20reports%20of%20suspected%20adverse%20reactions%20to%20oseltamivir%20(Tamiflu)

New AIDS vaccine ready for Human Trials

The Canadian University of Western Ontario has developed a new HIV/Aids vaccine that is ready for human trials.The vaccine called SAV001H has been developed by the university at London, about 160 km from Toronto, in collaboration with Sumagen Canada, a subsidiary of the Korean pharmaceutical company.In a statement Tuesday, Sumagen Canada said it has submitted an application to the US Food and Drug Administration (FDA) to begin the first phase of trials of the vaccine on human beings.Chil-Yong Kang, a professor at the university, said they have completed safety and immunogenicity studies of the vaccine on animals. Immunogenicity measures the ability of a drug or vaccine to provoke an immune response in the body. Trials of the new vaccine on animals have reportedly resulted in good anti-body reactions with no adverse effects.

Numerous trials have been carried out by pharmaceutical companies to develop vaccines , but no commercialised vaccine has been developed so far. Sumagen Canada has secured patents for the vaccine in over 70 countries, including the US, the European Union and Korea.It said the phase one clinical trials of the vaccine will double check its safety on HIV positive volunteers. The phase two trials would assess the immunogenicity of the vaccine. Sumagen Canada said it is ready for clinical trials in the US as soon the FDA approval is granted.The University of Western Ontario and the city of London have been short-listed by the Canadian government to set up an $88 million HIV vaccine manufacturing facility, which will be partly funded by the Bill and Melinda Gates Foundation.Last week Canadian scientists had announced a major breakthrough in Aids treatment by saying that they have found where the HIV virus hides in the human body.Currently, Aids patients have to take a cocktail of six drugs to prolong their life up to 13 years. There are over 33 mn HIV patients worldwide, with 2.7 million more getting infected each year.

Source: Clinical Research Forum

Swiss CRO moves into Indian clinical trials market

Switzerland-based contract research organisation PFC Pharma Focus has set up an Indian subsidiary with the help of Excel Life Sciences, a US firm that specialises in running trials in India.PFC India will be based in New Delhi and offer clinical trial support services such as study planning, monitoring, audit and data management services to biopharmaceutical companies and other CROs.India is fast becoming a global hub for clinical research, with the number of trials carried out each year growing by 50% a year, according to PFC. That view ties in with a report published by RNCOS earlier this year, which found that at present around 2% of all clinical trials in the world are carried out in India. That proportion is expected to more than double to 5% by 2012.The rapid growth is expected occur on the back of India's huge pool of potential trial participants, ease of recruitment and cost savings that could slash the cost of trials by 50-75% compared to the US or Europe.The new PFC India venture "combines the strengths of a long standing and successful European CRO" with ELS' "local expertise," PFC and ELS said in a joint statement.Their New Delhi unit will allow them to "offer our clients access to a large diverse patient population as well as to a significant number of patients suffering from rare diseases", said PFC's chief executive and co-founder Dr Kurt Pfister.Despite India's potential, there have been some brakes on growth, including some scandals relating to unethical trials, delays in approvals, inadequate protection of clinical data and a lack of Good Clinical Practice-compliant sites and investigators. Last year, for example, the industry suffered a knock to its reputation after an investigation was launched into 49 infant deaths seen during trials carried out by the All India Institute of Medical Sciences (AIIMS) in New Delhi. The Indian government recognises that clinical research could be a major growth industry in the country, and has been taking steps to improve oversight of the sector. Last week it implemented a scheme whereby all companies conducting clinical trials in the country are required to list studies in a registry operated by the Indian Council of Medical Research (ICMR).The register has run for a couple of years on a voluntary basis, but is now a legal requirement. It is freely accessible to the public. "The Drugs Controller General's office of India is stepping up its compliance standards," commented Dr Vijai Kumar, president and chief medical officer at ELS.At the same time, "pharmaceutical companies are requesting a high level of service, preferably from an experienced and established brand," he added.

Source: www.pharmafocus.com

SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application

SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application Suite Offers fully automated capabilities in management of clinical trial process, clinical trial data and global adverse event reporting MUMBAI, India, Aug. 5 /PRNewswire/ -- SIRO Clinpharm, a global, full service Contract Research Organization (CRO) founded in India, today announced the successful completion of the implementation phase of the Oracle Life Science Application Suite (OLSAS) by going live with Oracle Siebel Clinical Trial Management System and Oracle Adverse Events Reporting System. "We are excited to have the rollout of the entire OLSAS as per our plan for the India operations," said Dr. Ajit Nair, President, India Operations, SIRO Clinpharm. "This will help us manage critical tasks in clinical operations and drug safety in an efficient and globally compliant manner, thus providing our clients the best of technology support to run trials more efficiently." After this implementation, SIRO gains complete operational functionality of the Oracle suite. SIRO, in April, had gone live with the industry standard Oracle Clinical and Oracle RDC, integrated with TMS for its Clinical Data Management Services. The OLSAS product portfolio for SIRO is comprised of Siebel Clinical Trial Management System 8.0 (CTMS), Adverse Events Reporting System 4.6 (AERS), Oracle Clinical 4.5.3 (OC), Remote Data Capture 4.5.3 (RDC) and Thesaurus Management System 4.6 (TMS). SIRO plans to roll out the OLSAS to its European operations soon to have the system working in all geographies in which the company has operations.

About SIRO
SIRO Clinpharm Private Limited (SIRO) is among one of the leading global Clinical Research Organizations (CROs), offering full scope services, conducting clinical trials in the pharmaceutical, biotechnology and medical devices sectors in compliance with international standards. SIRO is one of the first CROs founded in India, which caters to the needs of pharmaceutical companies across the world. The company has offices in India, USA, Israel and in Germany, Romania, Estonia and Greece. SIRO has recently opened offices in Czech Republic & Spain.

SOURCE SIRO Clinpharm

Human clinical trials for stem-cell research on cards

In what is seen as a boost to the stem cell research in the country, India would soon get to host human clinical trials for therapies using umbilical blood cord (UBC) stem cell. Chennai-based Apollo Hospital, America’s largest stem cell company StemCyte and Dr Wise Young, a leading expert on spinal cord injury, are in talks for conducting clinical trials in India using stem cell derived from UBC.
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