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I disagree with the implication that Denosumab cannot extend survival and with the assertion that Denosumab is not an “anti-cancer” drug.
GSK/VRX are working on a modified release tablet formulations of ezogabine:
http://clinicaltrials.gov/ct2/show/NCT01332513?term=NCT01332513&rank=1
Problematic point in the data is obviously the lack of statsig improvements of Relovair when compared with the LABA component of the combo (VI). I wanted to go back and check if other LABA+ICS combos (Symbicort, Advair, Dulera, Foradil) produced similar magnitude in their (shorter) 24-week trials, but didn't get there yet.
A more recent estimation by The World Health Organization is that there are approximately 170 million people around the world chronically infected with HCV. I think the number of patients with chronic HCV in EU is now higher than that of the US.
That part in the Hebrew edition is the journalist's view, not something Teva's people said.
Globes English edition is horrible.
Exactly so.
UTHR
Good point on mono vs addon trial. Makes me realize the risk in FREEDOM-C2 is higher but perhaps you're right and they can file based on FREEDOM-M data alone.
If the drop out were really low this time, they probably have found a way to dose escalate up to 3mg, which is an efficacious dose of Remodulin, but looks like patients did not have sufficient time on that dose (Dr. Rubin's point).
We both have no position but have an acquaintance with PAH.
Quest Diagnostics (DGX)
UTHR/FREEDOM-M trial for oral Treprostinil
Tyvaso also showed improvement in placebo-adjusted median 6 minute walk distance of approximately 20 meters and missed its secondary endpoints in TRIUMPH study, but was approved.
"Being in step with society" a la Andrew Witty
Several large drug firms have announced big cuts to the amounts they charge for their vaccines in the developing world
http://www.guardian.co.uk/global-development/2011/jun/06/immunisation-developing-world-drugs-companies
if the drug has two targets then one can't be sure in general which one (or even the combination) is the key to a particular response.
The most important parameters when selecting the best treatment are: the cytogenetic profile, followed by co-morbidities and stem cell transplant eligibility. A stem cell transplant physician will consult on pre-transplant induction therapy cause some agents can decrease the chance for a subsequent BMT.
They probably will try CHOP or CHOP like regimen first.
Alimta was approved by the FDA and EMEA as a front-line nonsquamous NSCLC maintenance therapy 2 years ago (#MSG-39303562) and the continuation maintenance setting makes even more sense. Tareceva was approved in the front-line NSCLC maintenance setting a year ago (#MSG-49106892), but as you noted we should not expect that this will increase sales.
Rituxan is a case in point where sales in NHL has increased a lot by use in the maintenance setting.
Revlimid might have good* maintenance opportunity in the post autologous stem cell transplantation setting where therapy could last few years and is also being tested in phase III as a maintenance therapy for post R-CHOP in DLBCL.
*Tox, specificaly neutropenia and the risk for new malignancies could of course stop or lessen long term use with the drug.
It was Wyeth/Elan that did the “nonlinear” reanalysis and presented the data at the ICAD meetings in July 2008:
http://www.slideshare.net/finance12/wyeth-phase-2-clinical-trial-of-bapineuzumab-icad-july-2008
Coury said investors should focus on the patent case more than the regulatory progress.
Perhaps because ApoE4 genotype prevalence among AD patients in north EU and USA is around 60% and they hope that if they start the anti-Aß therapy early - before the ß-amyloid plaque burden is too heavy, it might improve the patient's state.
One more concern I see about bapi phase II data is the lack of dose response related to efficacy* (in contrast to safety where vasogenic edema was dose-related).
*Both efficacy and vasogenic edema were related to ApoE4.
Master, don't you have these odds [odds of success in non-carrier near 60% and carrier around 25%] reversed?
I imagine Royalty Pharma's interest is only for the Savella royalty so what happens to the newly licensed compounds?
Cypress Bioscience/Royalty Pharma ditched CYP-1020.
From form 10-Q for PROTALIX BIOTHERAPEUTICS, INC.4-May-2011
We are working with Pfizer Inc., our commercialization partner, to respond to the CRL. We have already begun preparing our response to the CRL, with Pfizer's cooperation. We recently met with the FDA and received certain clarifications regarding the CRL.
It was striking that the two mutations that emerged in practice and were disclosed in the NEJM article were among those listed as possible by Ariad.
Don't worry IJ, temporary loss of mind is a very common side effect among us posters on message boards. Sanity will resume spontaneously when you have logged out :)
Big pharmaceutical companies and Stem-Cell Therapy
After munching Cephalon, Teva will have another stake in the area via Mesoblast.
Taiyo - another acquisition for Teva in Japan
http://www.google.com/hostednews/afp/article/ALeqM5jU9xKjBpOxf1Shgufehboumi6zDg?docId=CNG.a06b8d6954f5a1831260ef488b80a425.3c1
TEVA is up about 2% in TASE on the news.
Why bother with the settlement?
Teva to Acquire Cephalon in $6.8 Billion Transaction
http://finance.yahoo.com/news/Teva-to-Acquire-Cephalon-in-bw-530915376.html?x=0&.v=1
Bimonthly dosing (after the initial loading period) is already the de facto SoC for Lucentis in AMD, and the CATT study produced no data to change this
Recall Merck also tried to get an "improved niacin" by targeting the same receptor with MK-0354, which despite significant decreases in FFAs levels and absence of flushing failed to demonstrate effects on HDL/LDL-Cholesterol and TGs in phase II. Obviously, being a GPR109A receptor agonist isn't all.
I think no one has ever looked but there are other GPR109A agonists with little or no meaningful lipid-altering effects, so not sure this is due to lower affinity or maybe it's not the only MOA of niacin's effect on lipids. probably both. I would think that investigating this point is important for patients with severe psoriasis as they are at increased risk of cardiovascular mortality. Are you going to take this suggestion to ABT/BIIB or shall I?
Flushing might be unavoidable - seems like it's an agonist at the same receptor that causes niacin flush. (Strange if that turned out to be its MOA in MS and Niaspan worked for MS as well).
JCV immunoassay
But I wonder if the truth is more complex. Patients are only being told they are positive or negative. Is that really all the test does? Is there no measure of viral titer? Or is that being done and not being released? Or is this being done to establish some baseline counting on better tests later?
BG-12/Fumaderm
I think dosing is quite similar.
My wife who we now know is JCV positive
One thing to bear in mind about JCV(-) patients is that a certain amount of them is probably going to seroconvert in time.
Fumaric acid itself is poorly absorbed in the body however, Fumaderm is an enteric-coated tablet containing a mixture of dimethyl fumarate and calcium, magnesium, and zinc salts of fumaric acid monomethyl ester. Problem with this formulation is not absorption PO but side effects (GI-related and flushing) that cause a high rate of non-compliance.
I believe that dimethyl fumarate is rapidly converted in vivo to monomethyl fumarate, so not identical but the safety record of Fumaderm is quite relevant to BG-12.
Metastatic epithelial-to-mesenchymal transition (EMT) theory under fire
Cancer theory faces doubts
http://www.nature.com/news/2011/110419/full/472273a.html
Small Israeli company focusing on an area that not many are going into and a lot of hype. Sounds like a typical scam to me. Fwiw.