This morning I read about a public–private collaboration that reflects many of the latest trends in the drug industry today. The project began when the University of Pittsburgh Medical Center (UPMC) created the 21st Century Biodefense (21CB) initiative to enhance the nation’s biosecurity. Robert J. Cindrich, who is leading the initiative, said in a press release that the project’s goal was to foster advances in vaccine development and manufacturing. Battelle (Columbus, OH), a research and development organization, IBM (Armonk, NY), Merck (Whitehouse Station, NJ), and GE Healthcare (Waukesha, WI) have all joined the collaboration so far. Read more »

The announcement by the Bill and Melinda Gates Foundation late last week at the World Economic Forum in Davos, Switzerland, that the foundation will commit $10 billion during the next 10 years to help research, develop, and deliver vaccines in poor and developing countries is an important pledge for global public health, a commitment that the foundation is also hoping that governments and the private sector will participate in as well. Read more »

Pharma companies have been accused by a member of the Council of Europe’s Parliamentary Assembly of creating a false pandemic with regards to the H1N1 virus or “swine flu”. Read more »

Despite, or because of, economic difficulties and meager pipelines, the recent past has seen many drug companies investigate alternative delivery methods for new and established products. A new deal between GlaxoSmithKline (GSK, London) and Intercell (Vienna) reflects this trend and raises hopes for the development of innovative routes of administration. Read more »

GlaxoSmithKline (GSK) Biologics and Nabi Pharmaceuticals announced this week that the companies are partnering to develop an investigational vaccine for treating nicotine addition and preventing smoking relapse. The announcement is an interesting example of a novel application for a vaccine. Read more »

I’ve been paying attention to Merck’s (Whitehouse Station, NJ) Gardasil vaccine ever since I first heard of it because it’s a subject that combines biopharmaceuticals, gender issues, and the politics of public health. At first, critics contended that giving young girls Merck’s human papillomavirus (HPV) vaccine would not just prevent cervical cancer, but also promote promiscuity. This concern may have subsided, but two new wrinkles in the Gardasil story came to light on Friday. Read more »

Two recent news reports provided some good news for a change. First, FDA announced plans to award $2 million in grants for the development of pediatric medical devices. Read more »

Following up on last week’s post, it appears that the H1N1 flu vaccine is effective in older children, ages 10 to 17, based on preliminary results of an ongoing trial. This week, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that early results of clinical studies of the vaccine “look promising.” Read more »

Last week, I wrote that the increased attention to biological drugs, which are mostly taken through injections, was spurring interest in needle-free and implantable delivery methods for vaccines. Research into alternative delivery methods for vaccines could produce innovative ways of delivering other kinds of drugs as well, and I recently read about an inspired idea that a team of Boston researchers had for delivering intermittent doses of drugs. Read more »

The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8–10 days. Based on the manufacturers’ production schedules, things seem to be on track for vaccines to be available in four weeks.

But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu. Read more »