Cancer Vaccine Approved by Russian FDA
This is interesting: The Scientist reports Cancer Vaccine Approved by Russian FDA.
First cancer vaccine approved in Russia: A New York-based biotech company announced today (April 8) that it has received approval for the first therapeutic cancer vaccine -- in Russia. It is the first approval by a regulatory body of a cancer immunotherapy.
The therapy's approval in Russia won't in itself boost its chances for approval in the US or the EU, or improve the prospects of other cancer vaccines that are in the biotech pipeline, Ren Benjamin, senior biotech analyst at the New York investment firm Rodman and Renshaw told The Scientist. But Russia is "novel ground" for small biotech, he said: Seeking first approval in a country outside of the US and EU is a bold move, and both biotech companies and investors will be closely watching to see how lucrative a market Russia turns out to be.
It comes after the treatment didn't pass muster with the FDA, despite $425 million spent developing the treatment over 12 long years.
It would be interesting if small biotech firms find that gaining approval outside the U.S. and EU is a faster path to commercialization, leading to the possibility of using other countries as clinical trials for the U.S. market. Stay tuned...
Comments