We have had 3 days in a row without rain. That is most welcome. Today, I fear, we may lose our streak. It has heated up in Washington and so has the debate on healthcare reform. Another public figure who favors the sentiments of the Defense of Marriage Act goes down in lusty carnal flames. They are dropping like flies. Meanwhile, here is a little of what happened in our world this week:
- Caraco Pharmaceuticals Has Seizure! - The FDA announced that it had U.S. Marshals seize drug products manufactured by Caraco. The action followed a number of voluntary recalls and was based on the fact that in the FDA's estimation, the company's current Good Manufacturing Practices (cGMPs) were not up to standard after an inspection in May found unresolved violations. According to the company release on the matter, Caraco stated that "the company believes that corrective actions have been made and improvements are in are in process." The company also stated that this only affects products from its Michigan facilities, though it is a Detroit based company and the release does not state where the company has other manufacturing facilities.
- Schizophrenia Candidate Gets Complete Response Letter – In the very difficult category of mental health, H. Lundbeck announced that the company received a Complete Response Letter for its investigative compound Serdolect to treat schizophrenia. While it does not appear that the agency was seeking safety or efficacy information, according to the company release, they did ask for additional data on the target population for the drug.
- GSK Receives Complete Response Letter - In a press release that was curiously titled "GSK Update for Rezonic", GSK announced receipt of a Complete Response Letter from the FDA for its candidate drug to treat nausea and vomiting following chemotherapy. In what seems to be a standard statement style when receiving these letters, the company did not say if the FDA was asking for further safety or efficacy studies.
- New Healthcare/Pharma Folks on Twitter – Genentech began a Twitter-feed in May that just came to my attention. They have already developed a healthy number of followers since that time. Also joining the ranks of Twitter is Siemen's Health. By my count, there are now almost 20 companies on Twitter.
Time for me to hit the trail. Not the Appalachian one, I'm afraid.