Replies to post #113937 on Biotech Values

[genisi]

Apropos to cGMP issues, Teva received an FDA warning letter regarding its manufacturing practices at its Jerusalem manufacturing facility, which was inspected in September.

http://www.globes.co.il/serveen/globes/docview.asp?did=1000620442&fid=1725

[DewDiligence]

Re: Teva/APP generic Gemzar

Found out why Teva couldn't manufacture on their own - a cGMP issue with its Irvine, CA facility. They had to partner so they can at least enjoy some of the exclusivity period.

Moreover, since asking the question in #msg-59214635, I learned that Abraxis BioScience (APP Pharma’s ancestor) had done contract work for LLY on Gemzar.

[DewDiligence]

After losing in US court, LLY is arguing the Gemzar patent case against HSP before the ITC:

http://www.bloomberg.com/news/2011-03-17/lilly-claim-over-hospira-s-gemzar-copy-to-be-reviewed-by-itc-1-.html

Although unlikely, a recommendation by the ITC to impede the importation of generic Gemzar into the US would be a terrible precedent, IMO.