In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.
Archive for the 'Global Health' Category
As the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart, according to an announcement from HHS’s Office of the Assistant Secretary of Preparedness and Response. According to the announcement, HHS has awarded three-year contracts to all five US-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential before a pandemic occurs. HHS will choose the vaccine strains to be stockpiled, and expects that with vaccine seed stock already in hand, the government will be able to respond to a flu pandemic more quickly. Read more »
An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.
This blog post was written by Ben Comer of Pharmaceutical Executive magazine.
Recognizing that traditional market forces – namely incentives related to intellectual property and a steady demand for products – have failed in developing countries, the World Health Organization (WHO) asked a member state-nominated group to come up with ways to fund R&D and pay for the treatment of neglected diseases in the world’s poorest nations. The group’s proposals will be discussed at the sixty-fifth session of the World Health Assembly, beginning today in Geneva. Dr. Paul Herrling, a member of the group and head of the Novartis Institute for Tropical Diseases, sat down with PharmExec to explain the group’s process, conclusions and next steps. Read more »
The 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 »
When 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 »
The malaria vaccine candidate RTS,S is looking even more promising, according to preliminary clinical trial results published in the New England Journal of Medicine . Early data from a large-scale Phase III trial conducted in seven African countries show that the vaccination regimen “can reduce the risk of clinical malaria by more than half in African children aged five to 17 months during the 12 months after vaccination.” Read more »
Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. 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 »
When natural disasters such as Hurricane Irene strike, obtaining food, water, and supplies tend to be at the top of at-risk residents’ minds. Having necessary medication—and enough of it—is also crucial. Even before Irene hit the US coast last week, PhRMA issued an alert to the public about documenting existing prescription medications with the RxResponse online medication card tool. Read more »