Archives June 2011

International Drug Discovery and Clinical Research (IDDCR)  and the prestigious Temple University's School of Pharmacy  (TUSP), US, have joined hands in the delivery of global  certificate programmes to India. Starting in late August Clinical ReseatCti     IDDCR will bring Temple University s globally recognized Quality Assurance/Regulatory Affairs (QA/RA) graduate programme to students in Hyderabad, offering one-year Post Graduate Diploma Programmes that cover key concept? in the pharmaceutical industry. IDDCR intends to educate 80-100 select students in clinical trial management and global pharmacovigilance each year. The certificate programmes will help ease the demand for high-quality clinical trial and pharmacovigilance professionals from big pharma, start up, generic drug, biotechnology, and clinical research organizations in India. Founded in 1884 in Philadelphia, PA, Temple University is the sixth largest provider of professional education in the US, and its QA/RA graduate programme is the oldest and most comprehensive of its type in the world. IDDCR more...

Tylenol extra strength caplets became the latest in a long succession of Johnson & Johnson products to be  taken off the shelves after complaints of the pills' 'musty odour'. According to McNeil Consumer Healthcare, the US pharma giant recalled 60,912 bottles of the drug after customers criticized the product's scent, comparing it to that of mold. The odour has been linked to the presence of trace  amounts of a chemical known as 2,4,6-  (TBA), by-product of a preservative sometimes used on wooden shipping pallets. McNeil insist the move was based on only a 'small number* of complaints and added, "This voluntary action is being taken as a precaution and the risk of adverse medical events is remote." However, experts are now pondering the safety of purchasing over-the-counter medicines from the J&J brand.           

A World Trade Organization (WTO) panel has ruled China's export limits on raw materials, including some with pharma uses, as unfair after claims they drive up prices. In 2009, the US and Europe followed by Mexico, began a WTO dispute claiming export restrictions disadvantage foreign companies by driving up prices. This, in turn, gives Chinese companies an advantage, said me complainants. A panel was appointed for the same. They sided with the complainants and recommended that China stops levying the export duties and quotas. Ron Kirk, US trade representative, said, "China's policies provide substantial competitive advantages for downstream Chinese industries. They have also caused massive distortions and harmful disruptions in supply chains throughout the global marketplace." Raw materials covered by the ruling include zinc, magnesium, manganese, bauxite, coke, fluorspar, and silicon carbide, silicon metal and yellow phosphorus.

FDA concluded Avastin (bevacizumab) in combination with paclitaxel neither prolonged overall survival in metastatic breast cancer patients nor provided a sufficient benefit in slowing disease progression. The decision was followed by a review by the FDA advisory committee, which suggested removal of the breast cancer indication. Avastin in combination with paclitaxel got the green light in February 2008 under the agency's accelerated approval programme. Roche strongly disagreed with the decision and breast cancer patients have been testifying to an FDA panel. However, the FDA is unlikely to change its stand, seeing as how especially as five of the six members of the panel also voted against Avastin's use in breast cancer in July. An eagerly anticipated two-day hearing into Roche's appeal against the USFDA proposal to pull Avastin's approval for breast cancer has brought more activity at the agency's headquarters in Maryland. After a review of four clinical studies,  

Drugmaker Merck & Co Inc has announced that it will collaborate with the researchers at the University of North Carolina, the University of California and other academics on HIV research.                           A team of academics led by professors at the University of North Carolina Chapel Hill campus and assisted by Merck will research ways to purge HIV infections from the body. Another team of academics centered at the University of California San Francisco will research HIV reservoirs, areas where the virus may lie dormant. The National Institutes of Health is the primary funding organization for both efforts. Merck said it will not receive federal funding for its participation.

IBM has recently announced that the faculty from Harvard Medical School and Brigham & Women's Hospital would be using IBM business analytics technology for a new research that would examine the effectiveness of prescription drugs and identify potential safety issues. Harvard Medical research "‘teams are conducting advanced pharmaco epidemiology studies that look at the effects of drugs in large numbers of people based on insurance claims data. Using an IBM Netezza data warehouse appliance, the research teams will expand their study to analyze data from millions of de-identified patient records with the aim to develop new data- intensive drug safety research methods. "The ability to glean insight and act on the analysis of massive amounts of claims data will help Harvard Medical School extend its reputation as one of the largest and most respected medical research organizations in the world," said Arvind Krishna, General Manager, IBM Information Management.

SANYO expands the range of dual cooling  86°C freezers with the launch of the extra-large  capacity MDF-U700VX, an upright 728 litre  model that provides maximum sample security  for valuable research or clinical samples.   With two independent refrigeration systems  SANYO dual cooling freezers maintain  a reliable and uniform -86°C ultra low  temperature environment. When one cooling system suffers an unexpected failure, the other  circuit will keep irreplaceable samples safely around -70°C until service can be arranged. These features make the MDF-U700VX ideal for storing high- value samples in the biotech and pharma industries, stem cell research and regenerative medicine, tissue banks and blood transfusion centres, and other clinical and biomedical research facilities.

454 Life Sciences, a Roche Company, recently declared the launch and immediate availability   of the new GS FLX+ System, an instrument capable of generating extra-long sequencing reads upto 1,000 bp in length. This new level of performance presents a major milestone in the life science's industry, making it the first high-throughput sequencing technology to deliver millions of bases from reads with accuracy and lengths that are comparable to Sanger-based methods. The improvements in read length also translate to a 50 per cent increase in total throughput, aiding in overall run economics and further reducing the cost of large genomic projects.  The new GS FLX+ System is available as an instrument or as an on-site upgrade to GS FIX Instrument and features a redesigned reagent compartment to accommodate the larger reagent volume of the new GS FLX Titanium Sequencing Kit XL+. An increase in the number of sequencing flow cycles, along more...

Cytori Therapeutics Inc, a bio pharma company, has developed the Celution 800/ CRS System that has received regulatory clearance in Europe. Adipose tissue is introduced into the tissue collection chamber, washed to remove blood and free lipid and then digested with the proprietary enzyme reagent to release the Adipose Derived Regenerative Cells (ADRCs). The ADRCs are then concentrated by short centrifugation and wash cycles before being mixed with the washed fat graft material (also currently prepared by the physician. The process is controlled through automated sensors and processing algorithms to ensure consistent handling of the tissue and cells. The Celution 800/ CRS System is a complete system that prepares ADRCs for clinical use. The system provides rapid, automated tissue and cell processing in an optimized reproducible system. Further, the automated tissue and cell processing reduce the manpower requirements. Again, this as a tissue delivery device and allows the surgeon have more...