The malaria vaccine candidate RTS,S is looking even more promising, according to preliminary clinical trial results published in the New England Journal of Medicine . Early data from a large-scale Phase III trial conducted in seven African countries show that the vaccination regimen “can reduce the risk of clinical malaria by more than half in African children aged five to 17 months during the 12 months after vaccination.” Read more »

The development of an HIV vaccine is an important, but difficult goal, but researchers at the Massachusetts Institute of Technology (MIT) recently reported on an important advance in this area. One challenge in developing an HIV vaccine has been the difficulty in measuring how effective a vaccine is in producing an immune response. The MIT researchers have resolved that challenge by developing a high-throughput automated assay to evaluate individual T-cell response. Read more »

Worried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.

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Ever since 1996, when scientists succeeded in cloning a sheep by transplanting the genetic material from an adult skin cell into an egg from which the genetic material had been removed, ethicists have been waiting for the other shoe to drop: If a sheep can be cloned, then surely human cloning cannot be far behind (1). In reality, cloning by somatic-cell nuclear transfer is a very difficult process. Even in species like sheep and mice where the process has been demonstrated, success rates are low, and there are many species—including humans—in which no one has been able to repeat the process. Read more »

Earlier this week, the European Commission (EC) at last clarified what information pharma companies are allowed to disseminate to the European public about prescription-only medicines. Although direct-to-consumer advertising (DTCA) of such medicines is part of everyday life in the US, it is banned in Europe. Historically, there has been no way for companies to convey the benefits of their products, and in recent years this has become problematic as patients take an increased interest in their own health and treatment programmes

The move by the EC this week will somewhat relax the stringent control, but it’s important to differentiate between providing information and full-blown DTCA. For a start, television, radio and general print media will not be allowed and the information will be factual rather than promotional. Read more »

Everyone wants to know what their equivalents in the market are making, whether they are a QA professional, a lab chemist, a supply-chain manager, a procurement officer, a division leader, or even a CEO. But salaries aren’t all that make job satisfaction possible. Factors such as proper staffing, level of outsourcing, mergers and acquisitions, training, benefits, company culture, and more contribute to one’s willingness to stay put–or seek other employment. We’d like to know what’s going on in your field, so please take our annual employment survey. The results will be reported in the December print issue of Pharmaceutical Technology and Pharmaceutical Technology Europe.

AstraZeneca’s announcement this week that it is investing $200 million in a new manufacturing site in China, the largest investment by the company in a single manufacturing facility, reflects not only the ongoing trend on pharmaceutical industry investment in emerging markets, but also speaks to the larger issue of ways to stimulate manufacturing investment in the United States. As President Barack Obama looks for support for his jobs bill from Congress and the public, a basic question is whether federal policy is on the right track to stimulate business investment in the US. Read more »

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

Bribery and corruption are not supposed to happen, but of course they do happen and no industry is immune. In 2009, the World Health Organisation estimated that healthcare fraud and abuse can cost individual governments as much as $23 billion a year.

Fortunately, there are many rules and watchdog organisation keeping a close eye on businesses to make sure everything is honest and above board. In the UK, bribery rules have recently been strengthened by the long-awaited (or long-dreaded depending on how you look at it) Bribery Act 2010. Although it’s UK legislation, it has a long reach. It will impact any corporate entity that conducts business in the UK and applies to business interactions both inside and outside the UK. Read more »

Immunology was the focus of the 2011 Nobel Prize for Physiology or Medicine with the October 3 announcement that the award will be shared by three whose work has been seminal in the understanding of immune system function.  Half the award will go to Drs. Jules A. Hoffmann and Bruce A. Beutler for their discoveries concerning the activation of innate immunity, and the other half will go to the estate of Dr. Ralph M. Steinman for his discovery of the dendritic cell and its role in adaptive immunity. Read more »