UN Pact Scuttles Anti-Vaccine Provision

Jill Wechsler Washington EditorA new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world. The credit goes to public health authorities and medical experts who challenged a provision blocking production of vaccines with the preservative thimerosal, the formulation necessary for efficient vaccine distribution in developing countries. Banning thimerosal in vaccines “would be a tragedy” that put millions of children at risk, stated GAVI (Global Alliance for Vaccines & Immunization) director Seth Berkley in the New York Times (Jan. 17, 2013). Read more »

Spot Shortages and New Approvals for US Influenza Vaccine

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October. I received one of the last doses the clinic had on hand, and two other places I called were already out. Apparently, others in the US have been experiencing similar situations. FDA Commissioner Margaret Hamburg posted Jan. 14 on the FDA blog that vaccines are available but FDA is monitoring spot shortages. Read more »

Silk Protein Preserves Drugs Without Refrigeration

Tufts University research shows that silk protein can be used to stabilize and maintain the potency of vaccines and other drugs that would otherwise need refrigeration. “Silk stabilization has the potential to significantly change the way we store and deliver pharmaceuticals, especially in the developing world,” said research-paper author and Tufts doctoral student, Jeney Zhang, in a press release. Read more »

Pharma’s Efforts in Developing Countries

Stephanie Sutton Pharm Tech EuropeThe past month has seen a lot of news about the pharmaceutical industry’s positive influence in developing countries, and this progress looks set to continue thanks to initiatives being launched by the World Health Organization (WHO) and the European Commission (EC). Read more »

Vaccine Tied to Narcolepsy

Stephanie Sutton Pharm Tech EuropeThe 2009 swine flu pandemic (and panic) has been forgotten by most, but regulators, global health organisations and pharmaceutical companies are continuing post-pandemic activities, which include keeping an eye on new cases of the illness and monitoring the safety of pandemic vaccines.

This week, swine flu returned to headlines after two studies published in the Public Library of Science appeared to confirm a link between GlaxoSmithKline’s Pandemrix vaccine and cases of narcolepsy in children in Finland. Between 2002 and 2009, instances of narcolepsy were around 0.31 per 100,000 people. In 2010, this jumped to 5.3 cases per 100,000, which equates to a 17-fold increase. 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 »

Two Early Cancer Studies Show Promise

Erik Greb PharmTech editorThe 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 »

What Patients Don’t Know Could Hurt Drugmakers

Erik Greb PharmTech editor

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 »

A Call for Clarity about Vaccines

Erik Greb PharmTech editorAs 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 »

Bright Future, Big Molecules

Erik Greb PharmTech editor

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 »

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