The US Food and Drug Administration today warned consumers to stop taking three over-the-counter versions of Zicam, made by Matrixx Initiatives (Scottsdale, AZ). The company has received a Warning Letter, but a product recall has not been issued. Read more »

For the first time in 41 years, the world is at the start of an influenza pandemic.  The announcement regarding raising the H1N1 influenza pandemic level from Level 5 to Level 6 came today from from Dr. Margaret Chan, director general of the World Health Organization. Read more »

While we at PharmTech are very proud of our peer-review process for ensuring quality scientific articles, I was a bit humbled to learn of a massive endeavor by the National Institutes of Health to enlist the help of more than 18,000 scientists to help in their peer-review process. To put things in perspective, the process is in response to NIH receiving nearly 20,000 applications for Challenge Grants, a new program under the American Recovery and Reinvestment Act (ARRA). According to the organization, the number of applications is about equal to the total number of applications it receives in one of its three major review rounds every year. The number of applications and the peer review process is the largest response in NIH history, according to acting NIH director Raynard S. Kington. Read more »

My colleague Erik Greb wrote an interesting blog post yesterday about new drug delivery technology reminiscent of childhood games. Games have changed dramatically, but the concept of using them to help educate applies today. Take for example, the problem of patient compliance. A video game called “Re-Mission” (HopeLab) is helping children and teens to “blast away” cancer cells (at least on screen). The point is that it empowers the young patient to take control, which unfortunately is not the case with many adult patients with cancer. Read more »

The United States Department of Health and Human Services (HHS) is trying to cover all of its bases as it seeks to stockpile a vaccine to fight influenza A (H1N1). GSK and Sanofi are first on the list of drugmakers that will work with HHS to meet its objectives. Research scientists are also preparing for possible drug-resistant strains by making progress toward a new type of drug that will be able to stop the spread of infection and possibly prevent initial infection. Read more »

Pfizer’s Free Medicines program, “Maintain,” launched last week, promising to offer relief to many newly unemployed Americans. It seems like a good idea, and perhaps it will shine a positive light on the industry. Unfortunately, Big Pharma’s good intentions may be overshadowed by new accusations of overcharging state Medicaid programs. Read more »

Heads up pharmaceutical marketing firms: your branded “freebies” at US medical schools may be on their way out. An editorial in the current issue of Archives of Internal Medicine is calling for the new policies on interactions between pharma companies and physicians, even would-be medical professionals. The editorial highlights a study in that publication investigating whether medical students’ attitudes may be influenced by exposure to small branded items such as pens, clipboards, notepads, etc. That study involved 352 third and fourth-year students from the University of Pennsylvania School of Medicine, which has a strict policy against promotional material, and the University of Miami Miller School of Medicine, which does not. Read more »

Swine flu hit my neighborhood this weekend. Three schools, including one about a mile from my home, are closed today. Developing a vaccine against the H1N1 virus have dominated industry discussions this past week and has been on the minds of many parents I know. It seems, too, that the rapid and efficient development of vaccines (not specific to any one virus) has been on FDA’s agenda as well, especially in terms of implementing the modern approach well known as its Critical Path Initiative. Read more »

The almost overnight public concern and media attention over the swine flu outbreak has again turned the attention to pandemic preparedness. Officials continue to encourage preventive actions and precautions, noting that, as of yet, it is still unknown whether current vaccines and antivirals will have any effect against the strain responsible for this outbreak. It is also unknown whether those who received a vaccination during the 1976 US swine flu outbreak will have some protection against the current strain. Read more »

Prospects for new heart-disease therapies looked grim last fall, when one of the world’s top drug companies, Pfizer, announced it would drop out of the arena of cardiovascular disease research. The news prompted an opinion letter published in last month’s New England Journal of Medicine regarding the “uncertain future of cardiovascular drug development.” This past week, however, Merck announced it would strengthen its efforts toward new heart-disease therapies through a license agreement with drug developer Cardiome Pharma Corp. of Vancouver, Canada. Read more »