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Well, well...I was able to nudge you off the fence :- )
Tell me about it, I need to explain that to my mother in law, who is on the drug.
I did say: "I really cannot guess what will be the FDA' position regarding early filing". I can see the arguments (assuming the 24-weeks data hold current profile) but my hunch is the FDA is not that open-minded...
Dronedarone (Multaq) Study for Permanent AF Stopped Early
http://mx.noticias.yahoo.com/dronedarone-multaq-study-permanent-af-stopped-early-155349008.html
Perhaps I should have emphasized the word cure in #msg-61679544 :) I really cannot guess what will be the FDA' position regarding early filing, but I do expect good 24-week SVR data from that trial and even see a reasonable chance for monotherapy to work in GT2/3 patients.
Guanine, uracil, cytidine, nucleotide/side, you name it - they have it :)
So VRUS has all promising interferon-sparing combos: all nukes, nuke + NS5A, and now nuke+PI.
Study points to possible aspirin link with Astra heart drug (Brilinta)
http://www.reuters.com/article/2011/06/28/astrazeneca-study-idUSL6E7HS1C620110628
Original study
http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.111.047498v1
In this case I won't need my dentist, I'll end up in the ER
Applying a hot towel is always a good idea, dear :) and yes, when the skin is warmer absorption is quicker. I once had the opposite case when I got to the dentist on a cold day after 15 min ride on the motorcycle and the local anesthesia didn't work for ages until I had the brilliant idea to warm my skin. Worked like magic.
On your link - wonder when will integrated pump/continuous glucose monitoring devices will turn into one single management system.
It's more of 'interesting' than 'promising' to me.
Something very simple and logical - heating the injection site
http://www.insuline-medical.com/technology.html
I don't know and cannot contribute much to what others have posted. Think that a truly ultra rapid-acting insulin coming from Novo or Lilly could well compete with current fast-acting market but I do have doubts about the 2 unpartnered programs from BIOD and HALO plus if Novo does not expect these tweaks to be highly consequential, they should know better than me. Going to meet next month with a small local bio that is going in this direction just with a different solution (other than tweaking insulin analogs), so perhaps I'll learn something new.
you’re talking to the person who posted those slides in May
Biodel's formulation intended to provide faster onset of action than the currently available fast-acting insulin analogues. Nvo also thinks the need is there as you can tell from slide 12:
http://www.novonordisk.com/images/investors/investor_presentations/2011/CMD2011/04_Diabetes_treatment_tomorrow_CMD2011.pdf
OT
600 calories/day is a concentration-camp regimen
Forgot Prana's compound which also showed reduction of CSF Abeta.
Different approaches but all aiming Abeta: Cytos (partner with NVS) has a peptide vaccine in phase II, Transition Therapeutics (partner with Elan) with a scyllo-inositol, NeuroGenetic, EnVivo, and Satori are all in the gamma secretase modulators area and CoMentis (partner with Astellas) has a BACE inhibitor.
The interesting part for me from the abstract taken together with initial data from the ADNI trials (#msg-37700576) is on the biomarkers results:
Ponezumab (PF-04360365) and solanezumab (LY-206430) both were shown to raise CSF Abeta levels (including Abeta forms that are thought to only be present in brain plaques), which may be evidence of biological activity i.e. Abeta clearance from the brain.
Bapineuzumab is the one mAb among these three that is believed to act also on the Abeta plaques but in its phase II data, there was no effect on CSF Abeta levels (there was a trend of lowering phosphotau - one other biomarker).
Although these are different trials, it would be interesting to see if/how changes in biomarkers will correlate with a therapy with disease modifying potential.
Will data on this come out at ICAD 2011?
Ponezumab (PF-04360365)
There were 3 posters (PK/PD, safety, and biomarkers) at ICAD 2010. This is the interesting one imo:
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=d04410b9-4beb-45cb-b405-4ea01bbf7bfa&cKey=f4c38166-98c9-4540-8905-12d48a5fc763&mKey={7C4F47AC-AD99-45B7-970B-F8414FE3AD4F}
Shire's Replagal is already the market leader for the treatment of Fabry disease and its new manufacturing facility in Lexington allows it to increase supply if needed.
http://www.bioportfolio.com/news/article/723496/European-Authorities-Approve-New-Manufacturing-Facility-For-Shire-s-Replagal-agalsidase-Alfa.html
As for Gaucher's disease market: "Shire anticipates regulatory agency submission of the VPRIV (velaglucerase alfa) manufacturing process at the new Lexington manufacturing facility by the end of 2011." Meaning more capacity around the time PLX should get approval.
I assume the hypothesis was based on the observation that C-terminal peptide segments within Abeta(1-40) and Abeta(1-42) have distinct structures, but I think a stronger reason for targeting N-terminus of the Abeta protein was because epitope mapping of sera antibodies isolated from AD patients immunized with the late AN-1792, revealed that the anti Abeta antibodies generated by the vaccine, primarily recognized the N-terminal residues of the peptide.
http://www.ncbi.nlm.nih.gov/pubmed/16130106
This was also observed in mice:
http://www.ncbi.nlm.nih.gov/pubmed/12379850
I think the potential market share for REGN's Arcalyst in gout flare prophylaxis remains small even if Ilaris is out of the game.
Shire’s Firazyr for acute HAE - with SQ and self-administration, it will be a winner.
Your post #msg-63567346 made me think about this :)
Eliquis (apixaban)
In ARISTOTLE, Eliquis went head-to-head against warfarin and was statsig superior on both efficacy and safety. No HR or p-value was disclosed today; full data will be presented at the ESC conference in August.
European Commission Approves Inclusion of Anti-JC Virus Antibody Status as a PML Risk Factor in TYSABRI Labeling
http://finance.yahoo.com/news/European-Commission-Approves-bw-3546161359.html?x=0&.v=1
Laquinimod looks lack luster compared to Gilenya and BG12
good for MNTA
Well, that's a typical MD for you. What is the BS about "We never realized that the brain was so important, ..."??? People have been looking into that for decades, and it would do this Dr. Bhoyrul some good if he followed the literature both in animals and humans.
As for ghrelin antagonists, they usually target the GHS-R1A receptors, which are also growth hormone receptors (GH). You would want to be very careful with manipulation of this system. I know of one test with ghrelin antagonist in type 2 diabetic patients, that evaluates its effect on glucose homeostasis, but not anything with obesity.
And here comes the rubber stamp:
EU approves Lilly's weekly diabetes drug Bydureon
http://finance.yahoo.com/news/EU-approves-Lillys-weekly-apf-1798489928.html?x=0&.v=4
It's interesting CBST is committed to start phase III for CXA201, but not CB-183,315.
Cubist Announces Positive Results from Two Phase 2 Trials, CXA-201 and CDAD (C. difficile-associated diarrhea) Program
http://finance.yahoo.com/news/Cubist-Announces-Positive-bw-775770410.html?x=0&.v=1
REGN – VEGF-Trap-Eye in AMD briefing docs out:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM259142.pdf
Dr. Rothblatt is definitely someone utterly different :)
Liked their comic book, thanks for posting.
I'd say Alpharadin is an anti-cancer drug.
Xgreva is different.
I think we agree on Denosumab. It is a bone targeted drug that reduces skeletal-related events, so it can be categorized as an "anti bone metastases" drug or "anti bone disease" drug but it also has a disease-modifying activity in cancer, which qualifies it as an anti cancer drug, IMO.
Something I disagree with is the point that "secondary endpoints do not change the prospects for Xgeva to a material degree" (#msg-63233655). I think pain reduction is a material one, clinically and commercially.