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Discussion in 'Santarus' started by Anonymous, Dec 15, 2012 at 8:41 PM.
Have the final hiring decisions been made? If not, anyone know when they expect to hear either way?
They are still interviewing this week for some areas. Good luck to you.
Has anyone been told they are going to Kansas City for a final interview yet?
How is this drug to sell?
so far extremely difficult! sure hope they fix that whole fda approval thing...
Thought Uceris was expected to be approved January 16 - here anything different? My offer is contingent on the approval of this medication. Also, any comment on why Uceris is expected to sell? It looked like the data did not offer much benefit vs comparative established agents one of which is a generic. Non- systemic, yet the adverse events were stated as being similar in the clinical trials. Any constructive comments?
Thought Uceris was expected to be approved January 16 - hear anything different? My offer is contingent on the approval of this medication. Also, any comment on why Uceris is expected to sell? It looked like the data did not offer much benefit vs comparative established agents one of which is a generic. Non- systemic, yet the adverse events were stated as being similar in the clinical trials. Any constructive comments?
There is no generic. The generic is for ibs not ibd
The company seems very confident Uceris will be approved on the 16th, but sometimes it seems like the FDA just needs more time and a 3-month delay wouldn't be unheard of... Is there ANYTHING in the data that could hold it up? Usually I see lots of articles when drugs are on the cusp of approval... But with Uceris I'm not seeing anything!
Yeah, what's the level of confidence here on approval of Uceris? Anyone??
Read the press release. The FDA has approved and returned the labeling to Santarus right before Christmas. Now the official approval on the 16 th.
Yes, but the article I read on Dec. 20th stated that Santarus "cannot be certain the FDA will approve Uceris in a timely manner or at all, despite the receipt of the initial proposed labeling."
With that said, I feel pretty confident everything's going to go through. Yet you never know with the FDA and it doesn't hurt to be prepared to look again. Things certainly look good though and I'll be keeping my fingers crossed!
Is Bill D going to make another KSB speech and hand out champaigne? Who remembers that? What a joke....... Please be careful of this company. If you are coming from an established company with experience, be careful. Yes, I am speaking from experience.
Ok, thanks for that valuable input fucker!
Seemed valuable to me. Especially the steer clear message of be careful of this company. Past or even present employees have the inside scoop.
Event – Santarus needs Uceris approval to boost flagging pipeline
Source EP Vantage
Company Santarus, Cosmo Pharmaceuticals
Date December 24, 2012
The Californian biotech Santarus might want to postpone its New Year celebrations to January 16, when its ulcerative colitis drug Uceris will come up for US approval. With a thin pipeline, Santarus needs Uceris to add an important source of revenue.
Despite a three-month PDUFA extension from October owing to issues relating to good clinical practices, the company has proposed launching the drug in the first quarter of next year. However, generic competition is right around the corner and Santarus will have to play a convincing game to prove that Uceris is the one to prescribe.
The problem with Uceris is that the data is not compelling enough to use first line vs. generics. It will be a second line medication. The company really does not gave much going on with it.
WRONG! Spoken by one who didn't land the job. Better luck next time sour grapes.
I see no sour grapes in that statement. What I see is truthful reality.
The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at Week 8 in the Uceris 9mg group was significantly greater than that seen in the placebo group (17.9% vs. 7.4%, P=0.0143; odds ratio (OR): 2.71). The combined clinical and endoscopic remission rate for Uceris 6mg (13.2% vs. 7.4%, P=0.1393; OR: 1.9) and for the reference drug Asacol 2.4g (12.1% vs. 7.4%, P=0.22; OR: 1.71) were numerically greater than placebo, but the differences were not statistically significant.
Not a blockbuster by any means.
Yes someone finally looked at the efficacy data. The adverse events were comparable also. "Dear doctor will you please use my me to medication that costs more and isn't established on any plans." "Well, no Johnny Boy Rep, i will use a generic first and then Asacol and then your Uceris." "Johnny, why on earth would you expect me to use Uceris first. Cant give me a single reason why." "Well doctor, it would really help out our stock that will soon be plummeting because Uceris is a bust and all we have is a bag of generic, that is why the company pays us so much less than the industry average