The buzz around Rx-360, an international pharmaceutical supply chain consortium headed by seven advisory panel members including Martin Van Trieste of Amgen, has been brewing for months. More than 125 people attended the consortium’s launch meeting in Washington, DC, last Friday, June 5—quite a few more than Van Trieste and his team originally expected. Clearly, the turnout demonstrated industry’s interest in working together to help improve supply chain security. Also demonstrating a yearning for cohesion were the results of the meeting’s live polling questions. Using devices to vote from their seats, 100% of meeting participants agreed that Rx-360 was needed. Most also said they would join or are considering joining the consortium. 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 »

President Obama’s plan for lowering the cost of healthcare relies partly on ensuring that affordable generic drugs are available to patients. This strategy is not likely to be palatable to innovator companies, who have tried various ways of delaying generic drugs’ introduction to the market. Read more »

The US Food and Drug Administration’s transparency task force promises to raise questions about why certain manufacturer information on drug products is kept secret. Read more »

Yesterday, Thomas Lavery, 63, of Irvine, California, was sentenced to four years and four months of incarceration to be followed by three years of supervised release by the US District Court in Concord, New Hampshire, for his involvement in a prescription drug diversion case, according to a court release. Read more »

Health and Human Services Secretary Kathleen Sebelius and US Food and Drug Administration Commissioner Margaret A. Hamburg announced this week the formation of a new Transparency Task Force at FDA. The task force, which is chaired by FDA Principal Deputy Commissioner Joshua Sharfstein, will provide recommendations about how to make FDA’s operations and decision-making more transparent to the public. As part of that effort, FDA launched this week an open blog to gain input from the public and will be holding a public meeting later this month. Read more »

In the latest news regarding the US Pharmacopeia’s proposed limits and test changes for heavy metals, the organization is expected to post new information on its website regarding its plans to revise General Chapter <231> based on its June 2–3 USP PNP stakeholders meeting. 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 »

As a kid, I enjoyed playing with remote-controlled cars. It was exciting to watch the cars speed around, turn where I wanted, and go where I told them to go. Researchers at Harvard have developed what could eventually be a drug-delivery method that’s not far removed from this childhood pastime. Read more »