A new clinical trial for an AIDS vaccine will take place in Africa and the United States. The program, announced this week, is a collaboration between the International AIDS Vaccine Initiative (IAVI), which will lead the trial, biopharmaceutical company Crucell (Leiden, Netherlands), Harvard Medical School’s Beth Israel Deaconess Medical Center, and the Ragon Institute, an organization dedicated to HIV/AIDS research. Read more »

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. Read more »

The pharmaceutical and biopharmaceutical industries have jealously guarded their intellectual property for years. Companies routinely use patents to prevent competitors from making generic versions of their drugs. When pipelines have weakened, companies have developed new formulations or delivery methods to extend patent protection for their established drugs. The economic crisis has only sharpened this reflex.

That’s why news from Ecuador made me do a doubletake. Read more »

This week the California Institute for Regenerative Medicine (CIRM), which is the California state body responsible for stem-cell research funding, and two international partners in Canada and the United Kingdom, announced awards totaling $230 million to 14 research teams in California, Canada, and the UK to develop stem-cell-based therapies for 11 diseases. The funding, in the form of four-year grants, marks the first CIRM funding that is explicitly expected to result in filings with the US Food and Drug Administration for initial human clinical testing of therapies based on stem-cell research, according to a CIRM press release. Read more »

Last month, US Food and Drug Administration Commissioner Margaret Hamburg announced the agency’s six-point plan for tougher enforcement of its policies and regulations as means of protecting public health. The plan, which includes actions like setting postinspection deadlines, speeding the Warning Letter process, and working more closely with FDA’s regulatory partners, was designed to “to prevent harm to the American people,” as Hamburg said in an FDA release. 

The agency has been actively involved in several recent cases involving instances of illegal importation and sales, drug diversion, and misbranding of drug products. Read more »

In the debate over establishing a regulatory pathway for biologics, the White House recommended this week to limit data exclusivity for biologics to seven years, according to a Reuters report. Reuters reported that the Office of Management and Budget Director Peter Orszag and Nancy-Ann DeParle, director of the White House Health Reform Office, sent a letter to Representative Henry Waxman (D-CA), chair of the House Energy and Commerce Committee, whose committee is considering biosimilar legislation, stating that seven years “strikes the appropriate balance between innovation and competition.” As would be expected, supporters of limiting exclusivity such as the Generic Pharmaceutical Association (GPhA) applauded the proposal while the Biotechnology Industry Organization (BIO) raised concerns. 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 »

As my colleague Maribel Rios discussed in her blog this week, the recent outbreak of swine flu gives us pause to consider our pandemic preparedness. The events of this past week also makes us more aware of the interrelationships and complexity of global public health, giving rise to an even broader question, has the pharmaceutical industry as a whole met its responsibility in effectuating global public health? Read more »

It is inspiring to read news about the advancements being made in the fight against viral infections, including those against influenza and HIV. However, as comments to recent blog posts have reminded me, the struggle to develop antiviral therapies is highly complicated because viruses have the infamous tendency to mutate and adapt in their fight for survival and conquest of healthy cells. A major part of formulating and developing antivirals is trying to get some handle on a virus’s unpredictable nature, how it will change, and how these modified forms will strengthen our understanding of its interworkings. Read more »

Last month, the International AIDS Vaccine Initiative (IAVI) and the Rockefeller Foundation announced a challenge to HIV/AIDS scientists: design an AIDS-fighting protein to win $150,000. The winning protein design and sample will advance HIV vaccine development, and the winning researchers could receive a bonus of up to $1 million and/or the chance to pursue their research further with help from IAVI. Read more »