tag:blogger.com,1999:blog-36634196.post4871495933499414546..comments2023-10-09T11:33:37.853-05:00Comments on The IN VIVO Blog: Surprise! Drug Approvals Increase In 2008Chris Morrisonhttp://www.blogger.com/profile/04075266444951558159noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-36634196.post-90768018117645359402009-02-26T01:15:00.000-05:002009-02-26T01:15:00.000-05:00The increase in new drug approval in 2008 has lead...The increase in new drug approval in 2008 has lead me to two interpretations- FDA with all the blames and criticisms over there head, finally decide to lax there standards or pharma companies are prudently submitting more relevant and efficient drug safety data’s (or might be taking less risky candidates for approval).Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36634196.post-34262651238916658502008-11-21T15:25:00.000-05:002008-11-21T15:25:00.000-05:00Thanks for the comment. I quite agree that this is...Thanks for the comment. I quite agree that this is no sign that the Big Pharma R&D productivity problem has been fixed.<BR/><BR/>A couple of points on the approval tally. First, there are in fact three imaging agents included in that total, so in that sense the number of therapeutics is even lower.<BR/><BR/>On the other hand, I did not include the Peg-Intron combo in the tally--and FDA has approved two more new molecules since the post was first published. So there really are 20 new molecules approved by the drug center this year. (And 17 new therapies, if you exclude the imaging agents).<BR/><BR/>On the third hand, some of those "new" molecules aren't so new--Pristiq for instance. That isn't any different than prior years, but it is one reason we try to track our own metric: Innovative Commercial Therapies. We'll publish that count at the end of the year.Michael McCaughanhttps://www.blogger.com/profile/09685341625525394208noreply@blogger.comtag:blogger.com,1999:blog-36634196.post-50339529234947865082008-11-21T13:55:00.000-05:002008-11-21T13:55:00.000-05:00While every NME approval is cause for rejoicing, w...While every NME approval is cause for rejoicing, we should be cautious about reading too much in the tea leaves, or, in this case, in the significance of Banzel's approval. One should point out that, among the 18 NME approvals for this year, there is one imaging agent (Iobenuane I 123, GE), and one peginterferon + ribavarin combination treatment for hepatitis C, which is hardly a new idea. The number of novel therapies approved so far in 2008 is therefore 16, with only 4 of these going to big pharmas. It is hard to argue with such statistics that R&D productivity is on the rebound. It is not, and the industry continues to face an acute problem of sustainability.Anonymousnoreply@blogger.com