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Isentress sales will further decline once dolutegravir is available and patients will switch as the latter has a better profile.
Probably true in many cases, but I was thinking of the fact that animal generic drugs have to be tested in every species they can be used for and that's a big hurdle.
Generic competition is a non-issue because there is no Hatch-Waxman-like framework for animal drugs and there is no involvement by third-party payers.
From the NEJM article:...
BMY's anti-PD-L1 is for viral infection, not oncology.
PKI posts another solid quarter in 4Q12. Reported $0.65 non-GAAP EPS for the quarter, right in the middle of guidance.
http://www.i3investor.com/servlets/fdnews/115825.jsp
Anti-PD1 drugs
One more positive point is that there might be a predictive marker - PD-L1 expression in tumors.
I'd heard some discussion before that CT-011 is not really an anti-PD-1.
TEVA dumps CureTech's anti-PD1
http://www.globes.co.il/serveen/globes/docview.asp?did=1000818643&fid=1725
I don't know but I think it depends on price, number of patients (with rare life-threatening diseases I'm certain insurers are reluctant to intervene), and profile of the generic vs the brand.
Time will tell and until Viread goes generic, which pill do you think will sell better Stribild or Complera?
Okāyouāre essentially talking about generic Atripla, a combination that is on its way toward becoming obsolete due to the superiority of II-containing regimens.
Most payors haven't even pushed for generic Prilosec over branded Nexium
Yes, of course I meant a single pill containing 3 generic drugs (Viread, Sustiva, and another generic NRTI).
I think that after Viread goes generic, payors can push to use in first line a one-pill-all-generic regimen of generic Sustiva and another generic NRTI and this will make life harder for branded regimens that are not superior.
GILDās āQuad Primeā advances to phase-3
Although genisi disagrees), TAF is a crucially important compound for GILD insofar as it effectively extends the patent life of the Truvada franchise.
I have posted once on Roy's board about this interesting little com. #msg-64676775 and it did very well since.
FDA rejected but CHMP gave positive opinion for Ilaris in gouty arthritis
http://www.novartis.com/newsroom/media-releases/en/2013/1671412.shtml
LIFE now up premarket on this:
" The board of directors of Life Technologies Corporation has retained Deutsche Bank Securities Inc. and Moelis & Company LLC to assist in its annual strategic review."
http://finance.yahoo.com/news/statement-life-technologies-board-directors-074500735.html
they set the clinical utility boundary as 30% below the placebo treatment
that is one of the weirder trial protocols I've ever seen
CANFY
Dubi, If you wanna translate for ghmm :)
http://www.sponser.co.il/Article.aspx?ArticleId=29476
Try this (sorry, there was a comma in the previous link)
http://www.parkinsontrial.ninds.nih.gov/pdf/neurology032006-66-664-671.pdf
Didn't mean a single arm trial. Was talking about a randomized, double-blind, futility clinical trial like this one in Parkinson's: http://www.parkinsontrial.ninds.nih.gov/pdf/neurology032006-66-664-671.pdf, where the threshold for futility was obtained from historical data.
The only time I might give it more weight is if I know the assumed HR was based upon a large base of data (e.g. a multitude of trials in similar indications) or if the company explicitly said they were using a Bayesian futility boundary.
failing a futility analysis is a strong sign of lack of efficacy
Yet the standard method of calculating futility treats the original assumption as much more weighty than the interim data.
Thanks, Clark. BAX noted that in general:
...futility analysis - an early analysis to determine if the trial should continue. A futility analysis is not intended to demonstrate achievement of efficacy endpoints.
BAX/IVIG Alzheimer's
This phase III trial of Gammagard is in mild-to-moderate Alzheimer's (http://clinicaltrials.gov/ct2/show/NCT00818662?term=Gammagard++alzheimer&phase=2&rank=2 ), which now we know is too late (better shot with the mild subgroup but will be too small), so low chance to be able to show impact on disease progression (cognitive and functional). The trial was not stopped for futility, so it probably has at least 20% chance of success.
ProCognia
New owners, new management, same science, still mainly a service provider. So still not a direct competitor to MNTA.
GIVN seeks āstrategic alternativesā:
GIVN
I was right about Humi:
http://maya.tase.co.il/bursa/report.asp?report_cd=790152-00&CompCd=2200&Type=Pdf
You can compare the language used by the FDA:
Brainsway's device is approved for the treatment of Major Depressive Disorder in patients who have failed to respond to antidepressant medications in their current episode of depression.
Neuronetics' device is approved for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.
Antidepressants are 1st line and a patient can try one of the TMS treatments before ECT.
Brainsway's depression treatment device is the second FDA approved TMS device for treating depression. Neuronetics has its device in the market since Oct. 08 #msg-34025303. Wonder how are they doing.
MRK knows that the drug will most likely be suspended by the EMA next week.
I need a lesson on baseball to understand your analogy
Ouch. MRK has dropped plans to seek approval for Tredaptive in the US; in countries where the drug is already approved, sales will presumably plummet.
My money is on GILD even if it is not first to market.
Interesting how times have changed. They are now running a 8-week arm in GT1 treatment-naive patients.
GILD reports SVR4 for sofosbuvir+GS-5885+ribavirin in null responders and more updates:
http://finance.yahoo.com/news/gilead-provides-hepatitis-c-development-133000022.html