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I trust your memory :)
PLX / KMDA
PLX, KMDA, and orphan exclusivity
When the CHMP recommend against marketing approval for PLX's enzyme in Gaucher (I was wrongly thinking PLX had a very good chance of bypassing Vpriv EU exclusivity then), it concluded that "Elelyso is similar to Vpriv, as they are both enzyme replacement therapies that work in the same way." Didn't matter how the enzymes were produced or their different glycosylation. Things could be quite different in court in patent litigation (I'm thinking of Enbrel).
I don't know what strategy PLX would pursue in the AAT case if KMDA gets orphan exclusivity but they are holding an analyst day here tomorrow, so perhaps we'll have answers.
PLX
PLX
Understood on the oral comment and agree it would be great but only preclinical PK data so far.
PLX's CEO is a religious man, no strings can be pulled as it's already Sabbath over here
PLX inhaled AAT
PLX
PSTI
PSTI the PR on the Clinical-hold Notice From the U.S. FDA:
http://maya.tase.co.il/bursa/report.asp?report_cd=820913-00&CompCd=1569&Type=Pdf
On sequencing and combo of treatments
KMDA
Xarelto® (rivaroxaban) has been approved by the European Commission for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome (ACS)
http://press.healthcare.bayer.com/en/press/news-details-page.php/15050/2013-0292
SNY announces that phase-3 for JAK2 inhibitor, SAR30250 in myelofibrosis meets its primary endpoint :
http://www.nasdaq.com/article/sanofipivotal-phaseiii-jakarta-study-meets-primary-endpoint-in-both-dose-groups-20130517-00031
Kamada already completed a phase II of it's inhaled AAT in 2009 but decided to wait for the AATD phase II/III data before moving on in CF. Could still be a very close race in CF.
GRFS/inhaled AAT
Note that Grifols is pursuing the CF indication while Kamada went for the AATD indication as it's first target. Data from Kamada's phase II/III of inhaled AAT is expected by year-end/early 2014.
http://clinicaltrials.gov/show/NCT01217671
I see that MYGN already published 3 peer-reviewed papers on Prolaris test with the Lancet oncology being the first in 2011. Full data from the Duke university study I linked to in #msg-87805550 should be published soon (has been accepted). As for GHDX, didn't see any peer-reviewed paper just the PR and Abstract no 2131 at AUA 2013 with no detailed data. So, at this point it is impossible to know which test is a better outcome predictor for prostate cancer patients.
I don't have access to the full paper but from the summary I see that the study demonstrated the CCP score was a significant predictor of disease outcome for both cohorts (the USA and UK) :
MYGN/Prolaris test
On MYGN's Prolaris test:
GM crops: A story in numbers
http://www.nature.com/news/gm-crops-a-story-in-numbers-1.12893
Impressive
I'm not so confident, it's my hunch based on what they said and what is known, which is admiringly not a lot.
I would go with 12 weeks without Riba.
GILD - from interim results seems that 8 weeks DAA regimen could work for GT1 naïve:
Gilead Reports Interim Data From Phase 2 LONESTAR Study
http://www.gilead.com/news/press-releases/2013/5/gilead-reports-interim-data-from-phase-2-lonestar-study
DYAX
Right you are and I forgot that mcbio already posted about that.
DYAX
Just one note to take into account is that there are a couple of late stage candidates that were developed using DYAX' tech and might bring them some royalties if approved (although in the low single digits).
DYAX's DX-2930
RCPT
There's still hope Brilinta sales will further improve (#msg-74891865)
Sphingosine 1- Phosphate (S1P) receptor agonists in MS
I suppose I'm not the only one who finds it funny not to say unethical that Dr Frost, who acts as the Chairman of the board at PBTH and as the CEO and Chairman of OPK, actually sold a company in which he holds 20% (PBTH) to a company in which he holds 40% (OPK).