InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
5,204.07
(
-2.67%
)
US TECH 100
17,496.40
(
-2.53%
)
Dow Jones
38,789.14
(
-2.39%
)
Brent Oil
76.24
(
-1.15%
)
Bitcoin
54,237.21
(
-6.25%
)
Post# of 252786
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Keep Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 834
Posts 120210
Boards Moderated 16
Alias Born 09/05/2002

DewDiligence

Member Level

Re: DewDiligence post# 184600

Monday, 01/05/2015 9:51:55 AM

Monday, January 05, 2015 9:51:55 AM

Post# of 252786
NVS’ Neupogen FoB gets clean bill of health from FDA staffers for Wednesday’s advisory panel:

http://in.reuters.com/article/2015/01/05/us-novartis-amgen-fda-idINKBN0KE12120150105

The reviewers recommended that Novartis's copy should be approved for all the five indications for which Neupogen is approved, the FDA said on Monday. Independent experts are scheduled to meet on Wednesday to discuss the drug and recommend whether it should be approved.

This is the first 351(k) (biosimilar pathway) application to reach the advisory-panel stage.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Public Reply Private Reply New Post
Keep Last Read
Keep Last Read Next 10 Report Keyboard Shortcuts
Next 10 Prev Next
Join InvestorsHub

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.

Sign Up