ISIS is ahead in game with EMA approval date 15th Novemeber 2012
Genzyme and Isis Announce Filing of U.S. NDA for KYNAMRO™ (mipomersen sodium) in ... Genzyme Announces European Approval of Framingham Manufacturing Plant ... Keep up to date by reading the latest press releases for Genzyme.
No it doesn't, it just means the manufacturing facility has the appropriate safety measures, checks, and balances to produce drugs - of any kind - it has nothing to do with what the drug itself. It is an essential step in that without it, they can't manufacture, but approval of the facility means nothing in terms of the drug itself.
It would be like getting an approval from a Health inspector on a kitchen and then declaring the food must be gormet. No it doesn't. It just means the kitchen is OK to cook in. Whether they cook gormet or weed rat stew is yet to be seen.