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 »

The coming patent cliff and the nation’s continuing economic problems have tightened many drugmakers’ R&D budgets. Cancer research has remained a priority, however, as GE Healthcare’s recent $1-billion investment in oncology demonstrates. Two recent studies show the importance of this research by offering glimmers of hope. Read more »

A few weeks ago, Representative Michele Bachmann (R-MN) made waves by claiming that the vaccine for human papillomavirus could have dangerous side effects. She retreated from her remarks after the American Academy of Pediatrics said that they had no scientific validity. Makers of biopharmaceuticals might feel vindicated, but a recent poll emphasizes that Bachmann is not alone in her views. Read more »

As I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »

The patent cliff is beginning to reduce Big Pharma’s sales figures as generic versions of branded drugs enter the market. Although FDA has remarked that pharmaceutical innovation is beginning to increase, not all companies are going to be able to market enough new drugs to make up for lost sales. So how will these vulnerable companies maintain their profits? Read more »

Last week, I complained about the British weather (which is still awful by the way) and outlined how the pharma industry is already preparing for this year’s winter flu season. Following on from that, I’ve just read a really interesting story about the holy grail of flu vaccine manufacturers — the possibility of a super, universal vaccine that could protect against all common strains of influenza. Read more »

Most of you are probably enjoying the summer weather. Unfortunately, I’m based in the UK where June and July have been saturated with wet windy days. To add to the wintery feeling, this week I’ve read a lot in the news about flu vaccines. Just as some of us in the north of England have already accepted that summer is over (before it began I might add), vaccine manufacturers are also preparing for this winter’s round of seasonal influenza. Read more »

This week has seen several pharma companies slashing the prices of important vaccines for use in developing countries, but is the move spurred by simple generosity alone? There are often headlines about pharma companies’ drug donations to developing countries and I think it’s great to see the pharma industry making a difference in this area. However, the price reductions may also stem from something other than generosity: the need to compete with other vaccine manufacturers, particularly at a time where more and more low-cost generic medicines are becoming available. Read more »

Mention New Jersey to someone on the street, and he or she is likely to think of Springsteen, the Sopranos, or (God forbid) Snooki. But PharmTech readers know that New Jersey is an important state for the drug industry. Many big companies, such as Johnson and Johnson, sanofi-aventis, Novartis, and Pfizer, have headquarters or other offices in the state. And the Garden State’s drugmakers are facing the same difficulties that confront the industry at large. Read more »

Even more than visiting the exhibit floor, I enjoy attending the presentations at INTERPHEX, which will take place next week in New York. The sessions always reflect the current hot topics within the pharmaceutical industry, and this year is no exception. Observers have been predicting that vaccines will be the industry’s new growth area, so my eye was drawn to the various biopharmaceutical talks listed on the INTERPHEX schedule of events. Read more »