GlaxoSmithKline has faced intense media scrutiny this week after being fined approximately 72 650 Euros by a court in Argentina for allegedly conducting unethical clinical trials on children for the company’s pneumococcal vaccine, Synflorix.

I always seem to be writing about GSK in my blogs but this is a much more sombre subject compared with the recent news of GSK CEO Andrew Witty’s knighthood. This week’s attention on GSK is focused on the COMPAS (Clinical Otitis Media and PneumoniA Study) study, which involved almost 24 000 children and was completed in Argentina in June 2011. The fine issued by the Argentinean National Administration of Medicines, Food and Medical Technology (ANMAT) related to administrative procedures in place for the study in 2007 and 2008. According to media reports (Sky News, CNN), some consent forms were signed by illiterate parents or people who did not have custody of the children. Claims have also been made that some children feeling unwell after vaccination were not seen by doctors. Read more »

Free trade, always a subject of concern for business, has been a topic of particular interest for the pharmaceutical and allied industries this past week as individual companies and trade associations weigh in on the debate on several free-trade measures. Read more »

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. Read more »

The pharmaceutical and biopharmaceutical industries have jealously guarded their intellectual property for years. Companies routinely use patents to prevent competitors from making generic versions of their drugs. When pipelines have weakened, companies have developed new formulations or delivery methods to extend patent protection for their established drugs. The economic crisis has only sharpened this reflex.

That’s why news from Ecuador made me do a doubletake. Read more »

The first-ever BRIC Economic Summit was held this week in Yekaterinburg, Russia, further signaling the importance of Brazil, Russia, India, and China, collectively known as the BRIC countries, in the current and future direction of the global economy. Some predict that the BRIC countries will surpass the leading economies by 2050, according to a recent New York Times article. The seeds of change already have been planted in the pharmaceutical industry, where pharmaceutical market growth in emerging economies is projected in the double-digits in 2009, compared with declining to anemic growth in established markets. Big Pharma is attuned to the shifting market dynamics. Many companies have clearly stated their strategic intent to enhance their positions in emerging markets. But what are the implications for pharmaceutical manufacturing? We may have gotten a glimpse into the future with some recent moves by Pfizer and GlaxoSmithKline (GSK). Read more »