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 »

First of all, I wish all of you a very happy new year! The pharma industry and its workers have been through a lot of hardships in recent times with huge job losses, eroding profits and drying pipelines. A lot of gloomy predictions have been made about 2012 (including ongoing economic woes and the end of the world) but let’s hope that this year finally brings good times for pharma as it seems that the industry is well overdue for a successful year.

For Andrew Witty, the CEO of British pharma giant GlaxoSmithKline, the year is definitely off to a good start after he was knighted for services to the UK economy and pharmaceutical industry. Sir Andrew as he will now be known received the royal recognition in the UK’s 2012 New Year’s Honours List. Almost 1000 people received awards of varying kinds.  Read more »

Earlier this week I read a great article on Reuters about how pharma companies are looking to the automobile industry for innovation by transferring some of the lean methodologies learned in car manufacturing to pharmaceuticals. As a pharmaceutical journalist, I read a lot of news stories and articles about innovative new products, R&D projects and partnerships, and sometimes it’s too easy to let your eyes gloss over these as everyday business. Earlier this year though, the partnership between GlaxoSmithKline the McLaren Group really grabbed my attention. Pharma… and a racing-car maker? That’s definitely not an everyday occurrence. Or is it? Read more »

It’s getting harder for the pharmaceutical industry to ignore neglected diseases. The globalization of national economies and the rise in air travel are increasing the potential for exposure to these diseases, which previously had been limited to the developing world. “Now is the time to have this discussion,” Kishor M. Wasan, chair-elect of the American Association of Pharmaceutical Scientists’s Pharmaceuticals in Global Health Focus Group, told Pharmaceutical Technology earlier this month. Industry now seems to be getting the message. Read more »

Partnerships and strategic agreements are common in the pharma industry. Flicking through my inbox of the last few days I see Bristol-Myers Squibb and Ono, Catalent and Toyobo Biologics… both very sensible. But one particular announcement this week gave me cause to raise my eyebrows and smile.

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 »

A possible link between cases of the chronic sleep disorder narcolepsy and GlaxoSmithKline’s H1N1 pandemic vaccine, Pandemrix, has led to a call from the World Health Organization (WHO) for further investigation. Narcolepsy is a rare condition with no currently available cure. Read more »

Big Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. Read more »

Journalists continue to comb through the latest batch of diplomatic cables released by WikiLeaks, seeking to interpret the mass of raw information. Until now, the cables’ significance has seemed to be limited to political circles. But one cable turns out to contain the 2008 version of the Critical Foreign Dependencies Initiative (CFDI) list, which names international facilities that could be considered crucial for American security. Perhaps not surprisingly, the list cites several pharmaceutical and biopharmaceutical facilities. Read more »

Two weeks ago I wrote about GlaxoSmithKline’s Avandia (rosiglitazone) being under the magnifying lens of regulators because of cardiovascular safety concerns and the verdict is now in: the treatment is being pulled completely from the EU market and will face severe restrictions in the US.

Controversy has surrounded Avandia ever since it was first approved but in recent months there has been increasing pressure — including published articles and a UK television documentary highlighting the risks associated with Avandia — on the FDA and the European Medicines Agency (EMA) to take action. Read more »