Personalizing for Better Products

Stephanie Sutton Pharm Tech EuropePharmaceutical drug development is becoming more and more expensive, with a high incidence of products failing late-stage trials. Governments and healthcare payers are demanding medicines that offer a balance of benefit and cost. Could personalized medicines and diagnostics offer a solution to both? Read more »

Public Safety versus Public Disclosure

Amy RitterWhen should there be restrictions on the dissemination of basic research results? This question has arisen in the context of papers from independent laboratories submitted to the journals Science and Nature. Ron Fouchier and colleagues from the Erasmus Medical Center in Rotterdam, the Netherlands and a team headed by Yoshihiro Kawaoka of the University of Wisconsin-Madison, were both studying the H5N1 strain of flu virus, which causes avian flu. Avian flu can decimate flocks of poultry, but is rarely transmissible to humans. Nevertheless, because of the close proximity in which humans and poultry reside, there is concern that the virus could someday acquire the ability to infect mammals, and become the source of a pandemic. Both laboratories, working independently, identified mutations in H5N1 that allowed mammal-to-mammal transmission, using ferrets as the experimental model. Read more »

Bring Manufacturing Back, Orders Obama

Angie Drakulich PharmTech editorLast night, President Obama issued a call to action for manufacturers that involves reducing outsourcing. His 2012 State of the Union address provided a blueprint for rebuilding America’s economy—and a large component is of that plan is to bring manufacturing back to the US. “Tonight, my message to business leaders is simple: Ask yourselves what you can do to bring jobs back to your country, and your country will do everything we can to help you succeed,” he said. Read more »

Celebrity Chef and Pharma Unite

Stephanie Sutton Pharm Tech EuropeEarlier this week, Novo Nordisk launched a diabetes initiative in the US that stars the celebrity chef Paula Deen. Usually, it’s the pharma company that gets the sharp end of the stick when it comes to criticism but this time the negative attention has fallen on Deen, with Norvo Nordisk barely getting a mention in many news sources. Read more »

Generic Drug and Biosimilar User Fees Gain Traction

Patricia Van Arnum PharmTech editor FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

A New Way to Share Best Practices

Angie Drakulich PharmTech editorEver wish you were a fly on the wall in another laboratory? Well, a new journal website offers the industry opportunities to do just that—to see through video how other scientists carry out particular experiments and processes. Read more »

GSK in Spotlight for Alleged Unethical Trials

Stephanie Sutton Pharm Tech EuropeGlaxoSmithKline 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 »

US Still Strong but Europe Waning in Life-Sciences Investment

Amy RitterA newly released report from Jones Lang LaSalle, a financial and professional services firm specializing in real estate services and investment management, looks at the world in terms of life-sciences investment, and finds some not-so-surprising trends over the past 10 years. The report ranked areas of the world according to how much direct investment they received in life sciences, and compared the rankings made between 2003–2006 with those made between 2007–2010. Those time periods were chosen to represent periods before and after the world-wide economic slowdown. Not surprisingly, on both lists, the US was number one, with Ireland, China, and Singapore also in the top 5 in both analyses. However, there have been some changes over the past few years. Puerto Rico, which ranked number 8 on the 2003–2006 list, failed to make the top 10 ranking in the 2007–2010 list. And Canada and Brazil, two non-European countries, replaced Sweden and France as top 10 recipients of life-sciences investments. India, ranked at number 9 in the 2003–2006 analysis, moved up to number 4 in the more recent ranking. Read more »

New Jersey Remains Strong on the Biopharmaceutical Front

New Jersey is known to many as a pharmaceutical mecca on the international stage with several leading pharmaceutical majors headquartered and/or with operations in the state. So to say that lawmakers need to create an economic climate conducive to foster growth is an understatement.

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GSK CEO Knighted

Stephanie Sutton Pharm Tech EuropeFirst 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 »

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