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(MYL)—TEVA’s generic EpiPen
Teva as usual does not give too many details.
This guy wrote a long piece on the EpiPen saga:
http://seekingalpha.com/article/3881636-generic-epipen-hold?li_source=LI&li_medium=liftigniter-widget
Re: KMDA shortens T1D trial
Enrollment has been very slow in this trial and I think the new CEO doesn't want to waste more time and money on this project.
Sounds like a desperation plan, but KMDA is down only 1% today.
What supposed to be a big deal to test patients for genotype?
I would also guess that since MON bought that software comp, their engineers are working on a tool for the "parent seeds" to be used by MON in its own fields :)
I'm just guessing but don't think the algorithms of the real-time data-analysis tools include genetic data of MON's own corn and soybean lots that produce MON’s commercial seeds and is to be used by farmers only.
BLUE/beta-thalassemia
none of the ß0/ß0 patients (~1/3 of overall BT patients) has attained transfusion independence
GSK’s Nucala (mepolizumab) for asthma
Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.
“Viekira 3QD” is also in ABBV's web with no explanation but I would bet it's a daily co-formulation of the "old" Viekira (the new part is dasabuvir as a QD instead of BID).
Teva would have got epipen approved long time ago with MNTA's characterization techniques.
BLUE chart from "Nature Letters" is dated in 2010, about 3 years post transplantation of patient 1003. They keep monitoring the patient but only report in general about his condition, so that was the chart I uploaded.
BLUE/expression of HbAT87Q
Indeed, if one reads the PR it is not clear what and why they have been monitoring along the years but I have been following a bit more closely and they were checking blood Hb concentrations and percentage of each Hb species (by HPLC), of total blood Hb concentrations (in g dl-1). So, the reason for the patient being "low on protein" is not because of waning of transgene expression but more likely related to his endogenous protein.
That's what I meant by "competition with the transgenic product in the formation of the functioning globin" (endogenous HbA competing with transgenic one). Could also be reduced endogenous HbA for some reason.
what those data mean for BLUE
BLUE
It would help to know more details of the slope of the waning over time
Re: BLUE gene therapy
The phenomena is called gene silencing
Re: PD-L1 expression test
Even if (and it is an if, as in CheckMate-017 Opdivo did better regardless of PD-L1 status, so I do think there are PD-L1 negatives who do respond to anti-PD therapy), PD-L1- (cutoff of 1%) patients didn’t have a stat-sig benefit with Opdivo vs docetaxel (and of course Keytruda is no option here), in terms of safety/tolerability, it is better than chemo. So why take another biopsy and not just prescribe Opdivo?
I do think PD-L1 status is more important for 1st line. So another question: which PD-L1 expression test to order? brings us back to your point that it will be difficult to know which drug has better outcomes.
Re: PD-L1 expression test
Meanwhile, the point in favor of Opdivo is its PD-L1 expression test is a complementary not a companion diagnostic.
The Cabilly patent is still alive after surviving quite a few battles including a current challenge from Sanofi-aventis/Regeneron.
Dako’s PD-L1 test for Opdivo is not exactly the same as its PD-l1 test for Keytruda
Re: Potentially game-changing oil reserves discovered in Israel
Many open questions that raise doubts about this discovery. I would keep my expectations low.
Opdivo-vs-Keytruda in advanced squamous NSCLC
RR was indeed impressive but as you noted only in the PD-L1-positive subgroup and docs will probably need a 2nd biopsy to define PD-L1 status among patients who had progressed. So currently my guess is Opdivo would do better in this indication.
Currently, for the squamous type, why would oncologists even bother sending another test (for PD-L1 status) if they can simply prescribe Opdivo? (it's a rhetorical question).
Haven't followed those closely.
They had to wrap it up before Yom-Kippur
https://en.wikipedia.org/wiki/Yom_Kippur
(Sorry for the Jewish joke, but this is the Israel-Medical-Healthcare board after all...)
They had to rap it up before Yom-Kippur
https://en.wikipedia.org/wiki/Yom_Kippur
(sorry for the Jewish joke but it is the Israel-Medical-Healthcare board...)
You bet!
No other news out. Doesn't smell right.
CANF going crazy!
FDA approves (private) Octapharma’s Nuwiq for hemophilia A
Never trust this kind of interviews. Besides, I cannot hear nor see anything because of the dust
http://news.nationalgeographic.com/2015/09/150908-middle-east-dust-storm-haboob-weather/?utm_source=GooglePlus&utm_medium=Social&utm_content=link_gp20150909news-duststorm&utm_campaign=Content
Shana Tova!
BVXV - met with them once long time ago and got a negative impression on their reliability so didn't follow closely since. Perhaps I will look again after this trial is done:
http://www.biondvax.com/2015/09/02/biondvax-announces-intent-to-launch-a-phase-2-trial-in-the-united-states-in-collaboration-with-the-u-s-national-institutes-of-health/
Re: GSK’s Mepolizumab for asthma
The jury is still out on the question if targeting the receptor (benralizumab) is superior to targeting the cytokine itself (Mepolizumab).
On clinically interpreted genomic data and the Clinical Genome Resource (ClinGen) program
https://www.genomeweb.com/scan/well-what-does-it-mean?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Scan%20Blog%3A%20Differing%20Interpretations%20of%20Gene%20Variants%2C%20This%20Week%27s%20Nature%2C%20Riken%20President%27s%20New%20Plans%2C%20more%20-%2005/28/2015%2001%3A00%3A00%20PM
Well, What Does it Mean?
As part of a set of papers on clinical genomics testing published in the New England Journal of Medicine yesterday, the team behind the National Institutes of Health's Clinical Genome Resource program reports that different labs around the country sometimes have differing opinions as to the clinical significance of the same gene variant.
"We have very clear documentation that there are differences in what patients are getting" back when the same gene variants are interpreted by different labs, the Laboratory for Molecular Medicine at Partners HealthCare Personalized Medicine's Heidi Rehm tells the Associated Press.
ClinGen was established in 2013 as a means of building a genomic knowledge base to improve patient care. Its ClinVar database contains more than 145,300 unique sequence and structural variants spanning nearly 22,900 genes that were submitted by 314 users, as GenomeWeb notes.
As Rehm and her colleagues report, of the 118,169 unique variants with clinical interpretations, 11 percent have clinical interpretations submitted by more than one lab and of those, 17 percent were interpreted differently by the various contributors.
Further, 415 variants have such differing interpretations that they would likely lead to different clinical decisions.
"The magnitude of this problem is bigger than most people thought," Michael Watson, executive director of the American College of Medical Genetics and Genomics, tells the Associated Press.
ACMG worked with the sequence and structural-variant communities to develop standards for interpreting genetic variants, and the ClinVar team says it is now helping labs adopt these standards. It adds that these standards have already helped some labs resolve differences in interpretations.
BXLT switched to an FVIII variant, which also increased gene expression in animal models. Whether the increased gene expression was the result of luck or skill is unclear to me.
Why is BXLT’s gene-therapy candidate for hemophilia A about two years behind its gene-therapy candidate for hemophilia B?
FDA-approved non-tyrosine-kinase inhibitor and their targets
Sorafenib - RAS/RAF
Temsirolimus and Everolimus - mTOR
Vemurafenib and Dabrafenib - B-Raf
Trametinib - Mek
Palbociclib - CDK
TEVA 1Q15 results, Copaxone figures:
In the United States, sales of Copaxone® amounted to $732 million, a decrease of 10% compared to the first quarter of 2014. At the end of the first quarter of 2015, according to March 2015 IMS data, our U.S. market shares for the Copaxone® products in terms of new and total prescriptions were 31.9% and 30.6%, respectively. Copaxone® 40 mg/mL accounted for 66% of total Copaxone® prescriptions in the U.S.
I sure hope Teva will walk away but am afraid Erez Vigodman will not give up yet and who knows how high he is willing to raise.
Re: TEVA/MYL—“Regulatory blockage”
Ok, thanks for explaining. So, that's another obstacle. Still wonder about the strength of the Dutch poison pill.