A few weeks ago, SmithKline Beecham’s Worthing West Sussex, U.K., site received an FDA warning letter related to, primarily, alleged failure to ensure microbiological contamination of products manufactured there. The site was inspected last March, and in April the Agency said that GSK's response to initial concerns lacked sufficient corrective actions.
The 60 Minutes interview with GSK whistleblower Cheryl Eckard is now available online here, after airing on CBS last night. Eckard primarily discusses the mixup of drugs at the Cidra, Puerto Rico facility and her efforts to not only stop outgoing shipments but to have the plant shut down.
A growing number of pharma CEOs are now dealing with the consequences of failing to care about workplace realities and what Toyota called the gemba, or place where truth will be found.If the idea of reading a book on ethics or philosophy is too off-putting....after all, it has been a...
Yesterday, I wrote on PharmaQbD.com about a new Morgan Stanley report which suggests that small-molecule drug manufacturers (and to a lesser degree biologics manufacturers) have very little financial incentive to perform their own research and development activities.
The talks started in earnest today, with five concurrent sessions. Most were dedicated to pharmaceutical applications, so it was “interesting” to try to cover many of them. One session, in particular, caught my attention: "New Directions and Modeling".
With global economies struggling it only gives drug manufacturers with sizable investment dollars more leverage to pit local and national governments against each other to see who can offer up the sweetest packages to earn the right to that money.
It's a matter of weeks now until we begin to see: a) to what degree the H1N1 pandemic will again ramp up; b) which manufacturers will have developed vaccines in time to address the need; and c) if those vaccines will work against the dominant strain that develops.
Have been away from the epicenter of political corruption for a while. New York is quite a bit tamer on that score than Chicago. Not so its tabloid headline writing (especially at the New York Post), which is as brilliant as it is uncivilized.