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FDA moves to stop 23andMe's Personal Genome Service (PGS)
Timothy Lee at the Washington Post disagrees with the move:
"Patients have a right to make dumb decisions if they want to "
In my view, he forgot to add the smile sign.
I could see BSX having a strong interest in acquiring the company.
GIVN
From the ''Globes'' piece:
The company hopes to obtain US Food and Drug Administration (FDA) approval by the end of the year. US marketing approval and insurance indemnification will add another $1.7 billion market.
CBST/CXA201 in cUTI: It is actually superior to levofloxacin even though it is a non-inferiority trial, 95% CI = 2.3%, 14.6%.
Result from another ph3 in cIAI will be in late Dec.
CBST/CXA-201 hits primary endpoint in phase III in cUTI
http://www.cubist.com/news/115-cubist_announces_positive_top-line_results_from_phase_3_trial_of_investigational_antibiotic_ceftolozane_tazobactam_in_complicated_urinary_tract_infections
JNJ might conduct bigger study to get the combo added to label, GILD certainly won't.
Simeprevir's actual label says the drug is "indicated as a component of a combination antiviral treatment regimen." That is written broadly enough to where it's not clear that simeprevir+sofosbuvir use would necessarily be deemed off-label.
Bear in mind that final data from the simeprevir+sofosbuvir combo are yet to report in early 2014 and we still need to see SVR12 in cohort 2, plus the number of patients receiving 12 weeks treatment is just about 40 in each arm. I do expect docs to want to treat patients with simeprevir+sofosbuvir off label but think just the more advanced ones, and I honestly don't see how they will overcome reimbursement issue.
Going with jq1234's line of thinking, tredaptive is another one.
Perhaps Benlysta can make it to the final five due to the disappointing uptake relative to expectations.
In AASLD data presented by Dr. Jacobson showed that patients with the Q80K polymorphism in cohort 1 had an SVR12 of 89% compared with 100% of those without Q80K. In cohort 2, this subgroup had SVR4=91% compared with 100% of those without Q80K. So, not bad at all but still patients with Q80K didn't do as good as those without it.
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4394-aasld-2013-simeprevir-sofosbuvir-produces-high-sustained-response-rates-for-hard-to-treat-patients
Those trials are either in difficult to treat patients or not in a combo with a second DAA. In GT1 naive patients regimen will not exceed 12 weeks treatment.
I assume your estimation "that ABBV’s 3-DAA regimen will garner about 100K of the available 260K patients per year in the US and EU, a market share of 38%" refers to a scenario in which both regimens from GILD and ABBV require 12 weeks treatment duration and both contain ribavirin (I think it is pretty sure both regimens have similar SVR rates in this case).
GILD clearly has a more positive viewpoint on the utility of a non-nuke in an all-DAA regimen
GILD already tested regimens of sofosbuvir + ledipasvir + either ribavirin or GS-9669 taken for 12 weeks in GT1 treatment-experienced with advanced liver fibrosis or cirrhosis in the ELECTRON trial and got SVR12 of 100%:
http://www.ic-hep.com/hepperspectives/aasld2013/library/PPTs/ELECTRON_Trial.pdf
So, I don't think GILD borrows a page from ABBV/ENTA rather they did try and still trying different combos to get rid of riba and shorten treatment duration.
I believe this is Evogene's most advanced program and if indeed it should enter phase III, chances for commercialization are quite high.
Evogene
The specific traits/genes under investigation and development are not mentioned that I have seen
[OT]—Mind-boggling stats re online shopping in China
I am one very happy number in that stats I can't remember when was the last time I actually went to buy running shoes in a proper shop. I get them by mail for less than half the price from that Chinese site mentioned in your link.
Evogene is one of the best performers among bio comps on TASE and is call 'the better half of Compugen' I like them but don't have the skills to really understand their platform, but MON seems to believe in their abilities and has a 8.6% stake in EVGN and this could increase to 9.4% after EVGN's US IPO, upper limit price for MON is $17/share.
GSK/darapladib
In the study of over 1,500 patients
Did Portola say on what precedent they base this clinical trial program?
PTLA reports phase II poc study of PRT4445 as Xarelto antidote:
http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsArticle&ID=1874725&highlight=
I would prefer nivo in combo with yervoy.
On ALK
Note that chances are not very high that your friend is ALK+ (is he a nonsmoker?), EGFR mutations are more prevalent and so you might need to consider starting him on another agent if enrolling into a nivo trial takes too long.
NVS' LDK378 has also shown activity in patients with brain mets and very high ORR regardless of whether or not patients had been on Xalkori.
Ariad' 113 looks more active in brain mets and better tolerated but still I wouldn't prefer any 2nd gen ALK inhibitor (and that of course goes for PF-06463922 as well), which available data are small, safety profile and duration of response are unclear, over Xalkori (unless as I've posted before, there are brain mets, then 113 would be my choice).
Progression of brain mets is a big worry in NSCLC with EGFR mutant or ALK positive but I don't see why it should happen while a patients is responding to Xalkori and before progression. Given that there is a time stress in your friend's case, I think that several months on Xalkori (average time to progression on Xalkori is about 9 months) could give the time to prepare for the next move and enter the next stage before progression would be better if possible. I would wait with ariad113 unless there are brain mets and clovis also a bit too early to be my first choice. All of course depending on mutation/s status.
You know cirrhotic patients are probably the hardest to treat given their impaired ability to metabolize drug via the liver, so I'm not surprised GILD is playing safe and not pushing to both shorten treatment duration and remove riba. I think ABBV is also testing its regimen for 12 or 24 weeks in cirrhotic patients.
BMS dual combo will lead in Japan as first entrant in GT1b and GILD will follow in GT2. In the GT1 trial GILD is enrolling both GT1b and GT1a for 12 weeks FDC +/- riba and my thoughts here are that Japanese patients are not as easy to treat because they are older (ave over 65) and more advanced with their disease. Also from the BMS data it seems that among virologic failures and relapsers, the most common variants harboured Y93H and L31M, two substitutions well known for conferring resistance to the NS5A inhibitor daclatasvir. So, again I guess GILD is playing safe here.
GERN imetelstat abstract
I don't understand the market excitement over these data from a single center study in 18 patients, that apparently neither can be defined as true CRs.
If tested positive for ALK then I would start with Xalkori, and upon progression I would vote for an anti PD-1. Data from BMS's phase I trial of nivolumab + combo of different chemo regimens, in chemo naïve NSCLC were really impressive. Should have activity in both squamous and nonsquamous histologies but PD-L1 is probably a critical predictor for nivo activity. Tough to say if with EGFR mutations to start with Tarceva or anti PD-1. I guess it depends on PD-L1 status and ability to enroll in a clinical trial. From my experience the best way to expedite the process to get into trials faster is to use personal contacts with the trial investigator.
price sensitive hasn't really been there.
GILD 6 weeks regimens
Indeed ELECTRON study data suggested that a third DAA was necessary for a 6-weeks regimen and the NIAID study I've mentioned is testing SOF+LDV+GS-9669 or +GS-9451 instead of Riba. These regimens (I would bet more on the one with the added PI, not the non-nuke), should certainly improve SE, efficacy and durability of treatment in naive non-cirrhotic GT1 patients. No other player is testing 8 weeks regimen so for GILD even the 8 weeks is good enough especially if Riba is out.
If ION-3 study will show that for some patients 8-weeks therapy is enough, then yes I think GILD will seek 8-week labeling. It can give then another angle for marketing.
Do you think 8-weeks of Sofo/Ledi would show superior SVR rates to 12-weeks of Sofo/Ledi in GT1A patients within a large study (n=600)?
GILD's SVR12 results from the LONESTAR trial 8 weeks or 12 weeks
Interpretation
These findings suggest that the fixed-dose combination of sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure most patients with genotype-1 HCV, irrespective of treatment history or the presence of compensated cirrhosis. Further clinical trials are needed to establish the best treatment duration and to further assess the contribution of ribavirin.
The trial is sponsored by the NIAID, perhaps because GILD doesn't think the 6 weeks duration will be good enough or as you quoted, not commercial enough.
http://clinicaltrials.gov/ct2/show/NCT01805882?term=13-I-0066&rank=1
More AASLD data: BMS triple DAA regimen, note the breakthroughs
http://www.aidsmap.com/page/2787586/
I think Ribavirin will be out. Furthermore, GILD is stretching it's DAA regimens to shorten the treatment to 6 weeks.
Since I follow the HCV space as an investor I would choose to wait (if able) for a better oral option
Possible Direct Effects on Vascular Endothelial Cells:
https://ash.confex.com/ash/2011/webprogram/Paper38845.html
But regarding the question "Can you monitor blood clot formation before lethal size clots occur", the ankle brachial index (ABI) can only identify PAOD not blood clot, so it can serve as a screening test for pre-existing PAOD before starting therapy (combined with vascular risk factors) and to monitor patients during treatment but like you indicated this won't prevent sudden death.