<p>Order of the National Green Tribunal in the matter of News item titled "Impact of Pharmaceutical toxicity on the environment and its regulatory aspects" appearing in Current Science dated
Pfizer Inc, the world's largest pharmaceutical company, will soon initiate programmes to develop drugs specific to diseases in developing countries, such as India, moving away from its history of fo
With global pharma companies waking up to technology outsourcing services as a tool to reduce the time to market of their R&D harvest, Accenture is looking at expanding the scope and scale of its life
What do many pharmaceutical companies across the world do when the number of new molecules that get past human clinical trials and the regulatory approval process is in steady decline?
The International Partnership for Microbicides (IPM) has signed an agreement with pharmaceutical company Pfizer under which the pharma major will give IPM a royalty-free license to use maraviroc, its newly approved HIV treatment, as a microbicide for the prevention of HIV infection. Maraviroc is one of a new class of antiretroviral drugs which works to prevent HIV infection by preventing the virus from gaining entry into target cells. "The drug's safety and efficacy data as a therapeutic will speed its development as a microbicide. This agreement adds a promising new compound to IPM's pipeline allowing us to explore new ways to prevent infection,' Zeda Rosenberg, CEO of the IPM told The Hindu here on Wednesday. Microbicides are products, such as gels, films and rings that could be applied vaginally to prevent transmission of HIV during vaginal intercourse. IPM is also developing other delivery methods such as long-last vaginal rings that release drug gradually over time. Under this agreement, IPM would work to develop maraviroc as a vaginal microbicide with the right to develop, manufacture and distribute the microbicide in developing countries that would reduce the cost of the end product and make it accessible to women in the developing countries, Ms Rosenberg said. Trials continue Admitting that the first general of microbicides products did not seem to work well, Ms Rosengerg said the good news was that large scale efficacy trials for the second generation of microbicides were on, and if successful, would be available in the market in the next five years. Results from the second IPM dapivirine ring study have shown that the reservoir vaginal ring was safe and well tolerated by women after seven days of use. IPM has finalised a protocol for a placebo vaginal ring safety and acceptability study to be conducted in Kenya, South Africa and Tanzania. The study, initiated in early 2007, will include 200 female participants and will generate critical data on the needs and preference of women and their male partners, in preparation for the eventual introduction of and access to microbicides among user population.
Philippines recently ordered Novartis to pull out its anti-arthritis painkiller from the country. It is feared that the drug lumiracoxib, also sold as prexige, causes liver damage. The Bureau of Food
a patent dispute between pharma companies over a migrane drug in the us market has been settled out of court. Ranbaxy, one of the world's largest producers of generic drugs, announced through a
For years the global malaria effort has been asking for more resources.Now the field needs to figure out a systematic strategy for spending the money effectively.
With money now flowing in, the fight against malaria must shift from advocacy to getting results. (Editorial)
THE public-private partnership model is now catching up in the drug R&D as well. In a first-ofits-kind partnership, the Rs 3,000-crore Nicholas Piramal Group on Friday signed an agreement with department of biotechnology (DBT) to jointly screen for biomolecules from microbes. The project cost is Rs 25 crore, of which Rs 17.98 crore will be contributed by DBT and Rs 6.88 crore by Nicholas Piramal. About 7,000 isolates per month will be collected and sent to Nicholas for screening, which will amount to 2 lakh molecules in three years. Joint collection will be done by nine institutes under DST such as National Environmental Engineering Research Institute, National Centre for Cell Science, Institute of Genomics and Integrative Biology, National Institute of Oceanography, etc. This is the first project in which industry and academia will work together to screen such a large number of bacterial isolates. The screening will be done for anti-cancer, anti-infective, anti-diabetes and anti-inflammation properties. In addition to culture-dependent method, culture-independent approach will be adopted for a few samples. "The global antibiotic market is worth $25 billion and there's an immense opportunity to increase the share of patents through the discovery of newer molecules. The partnership will eventually help us develop cheaper drugs,' said Union minister for science & technology Kapil Sibal.
Novartis, the Swiss pharmaceutical group, is stepping up the case for use of its experimental pandemic flu vaccine even ahead of a new virus mutation that could trigger a future lethal outbreak in humans. Jorg Reinhardt, head of vaccines and diagnostics, said the company would publish scientific data showing that its H5 vaccine stimulates rapid protection with a second booster jab against pandemic flu strains for at least seven years. Many specialists believe two flu injections may be necessary to provide significant protection from a pandemic, but there is far less current global capacity than supply. Reinhardt said a single flu vaccine shot would normally only offer protection after four to six weeks, but an initial jab would allow a subsequent booster to become effective within two to three days. His remarks come at a time of fierce competition between vaccine companies, which have invested significantly in pandemic flu and are attempting to recover their costs as international concern wanes. Companies including Baxter, Sanofi-Aventis and Solvay are all making arguments for the advantages of their own products, and GlaxoSmithKline raised the profile of its H5N1 vaccine last year when it agreed to donate to a "solidarity' stockpile for poor countries. World Health Organisation officials caution against labelling such products "pre-pandemic' vaccines, because they will only be effective if it is a mutation of the current H5N1 bird flu strain that triggers a pandemic. Others remain cautious about any preventative vaccination because of the cost and strain on public health systems, and concern that widespread use could trigger side effects. Reinhardt stressed it was up to the governments to decide whether or not to buy and use his vaccine. "We will share the data with everyone who is willing to listen and make the scientific argument that it provides protection,' he said. His comments came as Novartis unveiled a new Institute for Global Health at its vaccines research office in Siena, which will attempt to develop non-profit vaccines to protect against three salmonella-based infections that cause diarrhoea, one of the leading causes of disease and death in young children around the world. He said the institute, mirroring its work in Singapore to find medicines to treat illnesses for which there is no commercial market, would employ 50 scientists within three years and seek support from funds such as the Bill & Melinda Gates Foundation and the Wellcome Institute by the end of this year.
