FDA: 'Breakthrough' designation allows for drug approval on PhI data
2013 | By John Carroll
Share
One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies. So when Janet Woodcock, the influential director of the FDA's Center for Drug Evaluation and Research, started outlining how the program will work--indicating that a company can move from an expanded Phase I directly to commercialization, Bloomberg reporters were paying close attention.
According to the business news wire, Woodcock says that companies which earn breakthrough status will have the ear of the agency. "We expect many of these would come available very quickly with Phase I data," she said.
So far, we know that Vertex ($VRTX) has won breakthrough status for two drugs for cystic fibrosis, the approved drug Kalydeco and the experimental VX-809, now being studied as a combination therapy. According to Woodcock, a third drug has been anointed with the special status. And developers have submitted 18 for review, most of which are for cancer........This would sit well with MSB... Cheers Vin
Read more: FDA: 'Breakthrough' designation allows for drug approval on PhI data - FierceBiotech http://www.fiercebiotech.com/story/fda-breakthrough-designation-allows-drug-approval-phi-data/2013-02-12#ixzz2U6g56DLx
Subscribe at FierceBiotech
- Forums
- ASX - By Stock
- MSB
- ph1 ..then directly to commercialization
ph1 ..then directly to commercialization
-
- There are more pages in this discussion • 10 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add MSB (ASX) to my watchlist
|
|||||
Last
$1.00 |
Change
-0.065(6.10%) |
Mkt cap ! $1.141B |
Open | High | Low | Value | Volume |
$1.04 | $1.04 | 99.5¢ | $2.863M | 2.826M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
27 | 214205 | 99.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.00 | 6533 | 4 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
27 | 214205 | 0.995 |
17 | 110307 | 0.990 |
6 | 107113 | 0.985 |
10 | 40862 | 0.980 |
7 | 360965 | 0.975 |
Price($) | Vol. | No. |
---|---|---|
1.000 | 7319 | 5 |
1.005 | 37328 | 13 |
1.010 | 42649 | 11 |
1.015 | 37648 | 8 |
1.020 | 104131 | 8 |
Last trade - 14.37pm 04/09/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |