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Data on resistance are also being collected in other trials like the PSI-7977 + BMS-790052 see http://clinicaltrials.gov/ct2/show/NCT01359644 under Characterization of HCV genomic substitutions associated with exposure of BMS-790052 and PSI-7977 and phase III trials like http://clinicaltrials.gov/ct2/show/NCT01497366
GS-7977/Riba datasets
Q: When are these results due?
A: Results from ongoing studies in genotype 1 treatment-naïve patients will be available in the coming months. The first data evaluating GS-7977 plus RBV for 12 weeks in genotype 1 naïve patients will come from an arm of the QUANTUM study with 25 patients at the end of the first quarter of 2012. This will be followed in the second quarter by data from the ELECTRON study involving 25 patients and, early in the third quarter, data on GS-7977 and RBV treatment for 24 weeks from an arm of the QUANTUM study will become available.
Source: http://www.gilead.com/pr_1662331
Phase III trials of linaclotide in IBS-c had primary composite endpoint of Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder
I don't follow BCRX that closely and haven't looked at their HAE candidate. Perhaps a potential partner for gout will come after the 52 weeks data but like you said it's a crowded place.
BCX-4208 safety
Obviously, the nuke is potent enough to achieve RVR but needs something else in order to cure. I'm not sure yet that Riba will be an essential part of oral therapy using the pyrimidine nuke. It might be in GT2/3 but in GT1 and in nulls some other potent DAA (either a PI or NS5a inhibitor or both) instead is what it takes.
If you believe there's a good chance for PillCamColon 2 to be approved by the FDA next year, then definitely yes. They made good impression on me and as far as my not-so-good technical understanding goes, improvements made in the 2nd gen pill should allow it to pass the FDA bar.
PLX Gaucher
You've seen the numbers, they look good but we know the real big opportunity lies in the PillCamColon 2 and it's getting near.
Could be that 12 weeks are not enough and longer treatment will do better, could be resistance (I assume they are analyzing virus pre and post treatment), could be that another agent is needed.
Did GILD say if they will start testing a similar combo with their own NS5a inhibitor?
Diabetes treatments with new methods of action
TAK-875 - a GPR40 agonist is in phase III trials:
http://www.takeda.com/press/article_43205.html
There are several glucokinase activators in clinical trials (think that AZD1656 is the most advanced now after LLY terminated and Roch is on hold).
Using a weak inhibitor on its own is a bad choice as a rule, but even a very potent one will do better in combo and PSI-7977 in HCV a case in point.
Doebele et. al. also found diverse mechanisms (even two different ones in one lung cancer patient's tumor) of acquired resistance to crizotinib:
http://www.ncbi.nlm.nih.gov/pubmed/22235099
Also in the same issue of Science Translational Medicine where Katayama published (posted by ariadndndough in #msg-72153321), there is a good overview (I have the paper if you or anyone wants to read):
http://www.ncbi.nlm.nih.gov/pubmed/22323827
I'm not saying Pharmasset scientists were not aware that PSI-938 was active against 282T mutant, rather I'm saying they didn't design it to be so and were surprised to see its activity there. The fact that the work I referenced was published in March 2011 doesn't mean they didn't know that earlier, but if you read the paper it is clear that PSI-938 by its structure was not supposed to be active against the 282T mutant.
I believe PSI-938' different resistance profile was indeed one of the reasons it was advanced in the clinic along with it's different prodrug cleavage pathway and phosphorylation pathway but it was not designed (in part) to provide resistance against the 282T mutant, that was a lucky coincidence which was not expected. I was certain I've read about this a while ago and just managed to find that paper:
Ribavirin is still a riddle to me that is yet to be explained. Is it just a weak polymerase inhibitor (either an adenosine analog or a guanosine analog), or perhaps it has another MoA involved in the game.
BLRX - here comes the offering and dilution (will add them about $14M):
http://maya.tase.co.il/bursa/report.asp?report_cd=714587-00&CompCd=1394&Type=Pdf
The more peculiar detail I see has nothing to do with the previous settlement with Teva, mentioned by Peter. That's why my header was:
ANAC - GSK pauses trials
Hospira/Cubicin Paragraph IV
I don't think Europe will stay behind progress for long. The increase in GMO products worldwide is on the rise continuously and they will eventually and reluctantly approve.
AGN reported 4Q11 Botox sales of $415M +8% YoY and +5% QoQ. Botox outsold Dysport during 4Q11 by nearly 6:1.
Tau pathology spread in AD
The idea isn't new. One group showed evidence in-vitro and wrote: "We hypothesize that extracellular Tau aggregates can transmit a misfolded state from the outside to the inside of a cell, similar to prions."
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2676015/?tool=pubmed
And these groups showed the spread of tauopathy from cell to cell in the brains of tau transgenic mice by injecting brain samples in two mice strains:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2726961/?tool=pubmed
The phase-3 Solanezumab trials being conducted by LLY have futility analyses and passed them recently. (Source: LLY’s 4Q11 CC)
Rumor on a possible buyout target in India
http://www.vccircle.com/500/news/pfizer-teva-pharma-pe-firms-eye-micro-labs-buyout