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VRTX/VX-770 in cystic fibrosis - another smaller trial but in young children, hit its primary endpoint
http://www.reuters.com/article/2011/03/29/vertex-idUSL3E7ET22Q20110329?feedType=RSS&feedName=hotStocksNews&rpc=43
Just looked at the details and you're right: Repligen gets between 1.8% to 4% of annual net sales until December 31, 2013, and must also remit 15% to the University of Michigan.
The only patent I'm aware of, that Repligen has exclusive rights to with relevance to this pathway, is # 6,685,941. It pertains to CTLA-4Ig (a fusion protein between the extracellular domain of CTLA-4 receptor and the Fc fragment of a human IgG), with essentially an immunosuppressive effect. Contrariwise, Ipilimumab (an anti-CLA-4 mAb binds to CTLA-4 Helper T cells ), is upregulating the immune response and enhances the anticancer immune defense. In addition, the '941 patent claims are for treating autoimmune diseases, not cancer.
I think it's very very likely that Boceprevir will be approved but its label is unlikely to include null responders.
The EMA launched its clinical trials site:
https://www.clinicaltrialsregister.eu
Re: the yellow stickies atop of the list of messages on this board
I have another solution with fewer steps:
1. Use Firefox or Chrome as your browser (I prefer the latter)
2. Install AbBlock (add-on/extension)
3. Right click on the annoying yellow stickies or any other of their kind and mark "block"
Poof, it's gone.
Twenty of the 95 PML patients have died. If JCV test gains validation, I think seropositive patients already 2+ years on Tysabri will discontinue.
The Oppenheimer's recommendation on Teva
GILD's elvitegravir met primary endpoint of noninferiority compared with Isentress in a phase III study 145:
http://finance.yahoo.com/news/Gilead-HIV-drug-meets-study-apf-4283405651.html?x=0&.v=1
As far as I know they haven't met yet, they are communicating in writing.
Injections like self administration allow patients to be more independent. I think this is the major advantage for most people (not me, I hate needles). With routine maintenance, the risk for infection is very low with implanted ports.
Apixaban has received a positive opinion from the CHMP, for the prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery. Approval is almost certain.
http://www.reuters.com/article/2011/03/18/bms-pfizer-apixiban-idUSLDE72H18920110318
DGX buys Celera for $657M
http://www.reuters.com/article/2011/03/18/us-celera-idUSTRE72H3BX20110318
Lilly got a Complete Response Letter from the FDA for Amyvid
https://investor.lilly.com/releasedetail.cfm?ReleaseID=558665
That's the one!
That one took about 5 years to be dissolved. The one I'm thinking of is much longer.
Quiz: What is the longest consent decree ever?
Yes, I should have written that in the original communication with Genzyme, the FDA indicated that Thyrogen was not medically necessary. Only after negotiations GENZ was able to change that and convinced the FDA that it is necessary. Point is that companies can negotiate on terms of consent decrees.
CEPH
There's a good chance WPI will launch a generic Fentora soon:
http://finance.yahoo.com/news/Ahead-of-the-Bell-Court-rules-apf-44738219.html?x=0&.v=1
Even in the case of consent decree, it usually has to do with a specific plant. Sometimes, like with Genzyme's Allston plant, GENZ was allowed under the terms of the consent decree, to continue shipments for Thyrogen that is filled and finished at that plant.
IJ, as I've wrote elsewhere, very similar language* appears in the warning letter that Teva received for its Irvine, California injectable facility, which was received in December 2009. Irvine problems have not resolved yet as evidenced by the Gemzar manufacturing agreement with APP ( #msg-59484534 ), but that didn't stop the FDA from approving Teva's ANDA for Sensipar on May 14th, 2010. Bottom line, I don't think that the warning letter will prevent additional approvals or other products unless produced at this facility.
* "FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility, until the above violations are corrected."
IJ, these two events are unrelated as tuck and I noted a while ago:
http://siliconinvestor.advfn.com/readmsg.aspx?msgid=27143956
Given Imaging receives FDA clearance for expanded PillCam SB indications
http://finance.yahoo.com/news/Given-Imaging-Receives-FDA-iw-2710730402.html?x=0&.v=1
Well done!
This might reflect on GSK/THRX relovair as it also has a qd LABA component (vilanterol trifenatate).
Early, small number of patients, but indeed impressive.
First SVR data for mericitabine (a.k.a RG7128 ) for the Jump-C phase 2b study.
http://www1.easl.eu/easl2011/program/Orals/432.htm
No, I don't expect to see many switchers as most patients and docs are quite ok with Tracleer.
GILD has only few years left before Letairis goes off patent*, to try and take more market share from Tracleer that still has that warning in its label.
* http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=022081&Product_No=002&table1=OB_Rx