Monthly Archives: July 2008
A Black Friday in AIDS
Yesterday the hope of “a global AIDS vaccine in our lifetime” was pretty much shattered. Dr. Anthony Fauci, the longtime commander of the US’s wavering war on AIDS, delivered the last nail in the coffin of what had been a bold research and development effort by both Merck and the National Institutes of Health to [...]
Clinton Tinkers With Malaria Market
A team of reporters and camera crews packed into the headquarters of the Clinton Foundation on West 125th Street this afternoon to hear the details of former President Bill Clinton’s plan to tinker with the market for malaria drugs “in a way that has positive implications for the pharmaceutical companies,” he said.
Posted in Corporate Responsibility Tagged ACT, Africa, AIDS, artemisinin, Bill Clinton, Clinton Foundation, HIV, R&D 4 Comments
"Side Effects" and "The Normalization of Suspicion"
In today’s Wall Street Journal, Mark Herrmann, an attorney with Jones Day, co-proprietor of the Drug and Device Law blog, as well as an occasional contributor to Pharm Exec, has a lively review of Alison Bass’ Side Effects, a new book that tells the story of the campaign against Paxil.
His bottom line is a [...]
Posted in Corporate Responsibility, Safety Tagged Alison Bass, Drug and Device Law blog, GSK, Jones Day, Mark Herrmann, Paxil, Side Effects Leave a comment
No More Approvable Letters: An Expert's Take
In response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and nonapprovable letters for “neutral†complete-review letters, Russ Somma sent an interesting and informative take on the likely effect of the new system on the industry. Somma is president of SommaTech, a pharmaceutical development technology consulting [...]
Posted in R&D, Regulatory, Safety Tagged CDER, FDA, letters, NDA, neutral, nonapprovable, QbD, unapprovable 1 Comment

What a Week! Roche and Genentech … and Mirus!?!