The Drug Information Association has postponed its May 13-15 Latin America Regulatory Conference in Mexico City in response to the swine flu outbreak. View the media advisory here. Stay tuned to the DIA home page for updates and news about rescheduling.
I spent yesterday afternoon at the Forum for Medical Innovation in downtown Chicago, hosted by the Council for American Medical Innovation and moderated by former U.S. House of Representatives majority leader Dick Gephardt. The event also featured AstraZeneca CEO David Brennan as a guest speaker. [img_assist|nid=1172|title=David Brennan|desc=|link=none|align=right|width=128|height=86]
From Chemical Engineering Progress, Girish Malhotra presents his prescription for the pharmaceutical industry----QbD, PAT and control all play a key role, and chemical engineers will make it happen. The ultimate goal will be entirely new business models for pharma.
John Graham of the conservative California think tank, the Pacific Research Institute, just published a research report, Leviathan's Drug Problem, arguing that FDA is overstaffed, overfunded and unproductive. He traces patient wait times for new medicines as contributing to far more loss of life than food contamination.
Pfizer has decided to drop two late-stage drug candidates because, according to this AP story, it sees no real market potential for them. That is, it sees no blockbuster potential. And, as the article implies, this is in direct response to the Wyeth purchase and the fact that the company...
It all depends on how you look at things. According to new data, the number of new drugs approved by FDA in 2008 rose and was the highest it's been in three years. Not so fast, says blogger Merrill Goozner, who argues that numbers don't reflect what is really an...
Last week posed a scheduling quandary for anyone interested in Pharmaceutical Quality by Design and Process Analytical Technologies. Three important meetings were taking place....of course, the AAPS annual meeting in Atlanta, but also the Eastern Analytical Symposium and....the American Institute of Chemical Engineers meeting in Philadelphia.
Four universities--Hawaii, MIT, Purdue, and Rutgers--are collaborating on an effort, with support from the National Science Foundation, to apply modern analytical methods to traditional medicines in order to learn more about their properties. The researchers will use informatics and bioinformatics to establish a more cohesive database on traditional medicines.
Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis. And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W.