Hey, what can I say? It has been a dull week. Other than finding out that the conference on adaptive clinical trial design appears to be private, it has been really a no-news week. I am sad about the conference. So many from around the world were interested, but I guess they are not members of PhRMA and so they are on the outside. The FDA, meanwhile, could have chosen to lead, rather than follow, but it seems when given that choice, they always make the wrong one. Here is what happened this week, short list though it is. At least, new and interesting treatments were approved.
- Hayfever Gets New Relief – The FDA approved a new treatment for hayfever. The agency announced the approval of Omnaris (ciclesonide) nasal spray, a new drug for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever, in adults and children 12 years of age and older. Omnaris is manufactured by ALTANA Pharma US, Inc.
- Hepatitis B Treatment Gets Green Light – The FDA approved a new treatment for Hepatitis B that is chronic called Tyzeka (telbivudine). The compound is a new molecular entity and is manufactured by Novartis. The clinical trials lasted one year and studied 1367 patients.
- Update to Approvable Letters List – Despite the challenge to my technical skills on maintaining this blog, I have updated the Approvable Letters list under Resources by Me in the column to your left.
Have a good weekend everyone!
Is there a reason FDA is participating in a by-invitation-only conference on a major new initiative? Makes no sense.
I could not agree more. Who is driving the car?