Consider the following situation: You are out-licensing an innovative asset in a niche therapeutic area It is a first-in-class molecule It has successfully demonstrated efficacy in two international Phase…
Last week, Sandoz announced they are closing a number of generic product development centers around the world, including the Sandoz Development Centre near Mumbai. A few items in this report…
While we were recovering from our turkey-induced slumbers, we read the shocking news that Michael Porter's Monitor Group has filed for bankruptcy, and is being acquired by Delloitte . The…
We've had the good fortune to work with a biosimilars client this year. Working in this space has given us an opportunity to read and listen to many experts in…
As we've done in the past, we've tabulated the countries of origin from the stack of business card collected at BIO Europe 2012. Our "rules" for this analysis are simple.…
We’ve returned from BIO Europe 2012 in Hamburg with a stack of business cards, pages of meeting notes, prioritized follow ups, and some great memories. We managed to completely fill…
Bruce Booth (yet again) published a terrific post on his blog, entitled "NextWave of Pharma Innovation?" His premise is that reformulations, like the once-daily liquid methylphenidate product, Quillivant XR, is not…
There are some very interesting data published yesterday on FDA approval statistics: It was in 1984 when FDA first added the 505(b)(2) pathway for drug approval, a hybrid between the…
We spent a few days in Chicago attending the AAPS Convention. As usual, it was jammed with excellent science, tons of exhibitors, and great opportunities to catch up with old…
Next week, Lacerta Bio will be at the AAPS Annual Meeting in Chicago. If you have plans to attend, drop us a note! To follow the action on Twitter, use…