Sharckie, here's a good read on the bio sector, and the FDA's caution of late.
You da man, dude!
The panel will meet Thursday, and by day's end, it will recommend to the FDA whether to approve Amevive. The decision is crucial to Biogen, which badly needs a new revenue stream to compensate for flattening sales of its huge-selling multiple sclerosis drug, Avonex.
And in a year rife with setbacks and failures, the decision is also critical to the biotech industry. Industry observers say the FDA has become increasingly cautious in approving new drugs, repeatedly asking companies for additional information, delaying their approval, or keeping them off the market altogether. The setbacks, coupled with disappointing clinical trial results, have driven investors from the biotech sector. digitalmass.boston.com |