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MRK/odanacatib
It's hard to know as the stopped phase III trial was placebo controlled not against bisphosphonate as an active comparator plus long term safety is not clear: "The DMC noted that safety issues remain in certain selected areas and made recommendations with respect to following up on them".
Sorry for the belayed reply (I'm on vacation). If you want my view on GIVN, just follow the thread Roy started in #msg-72256508.
Dovi, hope you bought before that story posted in #msg-77202032. If so, take the money out. Otherwise, trust in god, this strategy worked well for the Rabbi (#msg-77207916).
It is also my understanding that Actavis can launch 'at risk' when the 30-month stay expire in Oct. But what if Teva is the exclusivity holder and gets approved tomorrow? the language in the link you've posted implies that Teva is the '1st to file'. And of course as you've noted a settlement is another possibility.
Actavis received a tentative approval for its version of Shire's Intuniv:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Apparently, the treatment only works for holy people :)
GSK/THRX Announce Positive Results From Four Pivotal Phase III Studies for Once-Daily LAMA/LABA (UMEC/VI) in COPD
http://finance.yahoo.com/news/gsk-theravance-announce-positive-results-060657631.html
Looks like the GPR119 agonist ARRY will take to phase I isn't AR-467947 but ARRY-981. This is the latest presentation which is about 5 months 'younger' than the one you've found:
http://www.arraybiopharma.com/_documents/Publication/PubAttachment518.pdf
While you had a lovely Sunday on the Northeast coastline, I was watching the Spanish footballers kicking the shit out of the Italians, winning the Euro 2012 final game 4:0
Found this in-vitro work relevant to your point on signaling:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2528830/
Well, I think all those GPR119 receptor agonists have demonstrated meaningful results in preclinical models of diabetes (sustained glucose control in prediabetic ZDF rats and substantial body weight lowering in DIG rats), but some already disappointed with poor clinical efficacy. The only one with positive clinical data so far is PSN821. I couldn't find clinical data from MBX2982, but guess they weren't so shiny cause SNY abandoned ship after seeing phase IIa results. We'll have to wait and see if ARRY's candidate behaves itself with humans as it did with rats :)
Sorry, MC stands for Market cap.
Not a coincidence that MCBIO knew that
"JNJ has completed the acquisition of CorImmun GmbH, a privately held drug development company in Germany, for an undisclosed upfront payment and a contingent future clinical milestone payment.
CorImmun's lead compound, COR-1, is a small cyclic peptide currently in early clinical development for the treatment of heart failure."
http://www.prnewswire.com/news-releases/janssen-acquires-corimmun-160660595.html
GPR119 receptor agonist in T2DM
Looks like efficacy issues also with the GSK compound, as presented in a poster at ADA last year:
Another possibility in the ERT/orphan arena is GEVA (not as expansive as BMRN and ALXN but not advanced enough and MC seems overvalued to me).
The most advanced GPR119 receptor agonistis in the clinic I could find now for type 2 diabetes is PSN821 (licensed to AZN). Seems that few big players (JNJ, SNY GSK) abandoned their candidates after phase II or earlier (from the limited data I've seen, guess on efficacy).
First, nice find on the modified language!
Although the 24-week post-therapy time frame is the gold standard everywhere (papers, guidelines, clinical trials endpoints), I've seen a bit broader term such as: "SVR, defined as undetectable levels of HCV RNA at least 24 weeks after completion of therapy" being used (emphasis mine).
The late relapse seen in ABT’s PILOT study might indicate that longer follow-up periods for monitoring late relapse may be needed in IFN free DAA combos, but then I wouldn't read too much into the language in the label of an IFN containing regimen as it could simply reflect the fact that VRTX has more post treatment data they asked to include in Incivek' label.
Peter, USL255 is not the same product but certainly a competitor for the 1xdaily extended-release topiramate.
Thanks for clarifying.
Corrupted Proteins Spread Disease #msg-76766626
The FDA found Teva's generic to be bioequivalent and therapeutically equivalent.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm153270.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=generic%20Wellbutrin%20Xl%20teva&utm_content=1
That's good enough for me.
Why was the tentative approval then?
In Roche Diagnostics PHC Investor Day page 96 they say the potential companion diagnostic for their MEK inhibitors are KRAS, BRAF, NRAS mutation
http://www.roche.com/irp110921.pdf
TKIs with varying degrees of selectivity
There is some degree of homology in the kinase domain and I suppose that's why some TKIs of the VEGFR family also work on other closely related receptor tyrosine kinases like Kit and PDGFR.
Apparently, most tumours can escape from the inhibition of any single kinase by the compensatory activation of other kinase/s and by mutations in the kinase domain so, developing multi-kinase inhibitors make sense (and combos as well).
Off-target drug effects could result from non-specific interactions of the TKI with additional target and/or indirect cross-talk between the targeted pathway and other pathways in the signaling network. These effects are hard to predict and there are computational models and cell assays to try assessing the possible responses that will occur in vivo and design safer and effective drugs, but as we can see, they are far from being perfect.
Here's is one approach to predict the sensitivity of a new drug or drug combinations based on known
kinase inhibitor targets
http://psb.stanford.edu/psb-online/proceedings/psb12/pal.pdf
Thanks, Peter.
I'm going from memory of the abs. only and think it said advanced, nothing more. Have you read the full paper?
I suppose they think that since most pancreatic cancer tumors express SPARC, the treatment should work for most cases and therefore level and place of expression is not an entry criteria but perhaps an observation.
I said I think "that the trial has better than 50% to be successful, but not so much because of the 'depleting the stroma' theory. My rationale is the phase 1/2 data on ORR, median OS and CA19-9 decreased levels, which were correlated with outcomes.
While I don't think the CRL is the end of the story for Xarelto in ACS, Lovenox players have no worries for the ACS indication...
Abraxane pancreatic cancer early phase I/II trial results
Abraxine / CELG(Z) pancreatic cancer:
The way things are looking now, 1B seems too high. Like you said, in breast cancer Abraxane looks more similar than different than paclitaxel and I think it will not be a commercial success in lung cancer either. Pancreatic and melanoma are a coin toss...
It's the 2nd case in a month that the fda briefing versus the fda's tone at the meeting were very different. In Xatelto's case (for ACS) things went the other way around i.e. positive review and negative panel.