paul
Researcher
Posts: 134
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Post by paul on Aug 29, 2019 10:32:16 GMT -5
It shows the lead author as being associated with the U. of Texas. She did a fellowship at the U. of Texas in 2005-2007: I suspect the data was collected about that time, but no one bothered to write up an article until now. They probably didn't publish at the time because exubera had been withdrawn from the market.
It says my linkedin link should appear but I'm not seeing it. You may have to google "Rucha Mehta MD,FACP" if you want to see it.
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Post by anderson on Aug 29, 2019 10:37:46 GMT -5
Is exubera still being sold outside the usa? This has been posted before but again.....
The plant that made exubera insulin was sold to Sanofi(MNKD was in the process of trying to buy it) and repurposed to make another type of insulin.
MNKD did buy a bunch of the bulk insulin(exubera api insulin) left and is storing the left over for Pfizer. They also have the rights to manufacture it for inhaled delivery.
So I think it is safe to say the startup cost to start manufacture exubera again far out weights what would be gained in selling it right now.
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Post by ktim on Aug 29, 2019 10:42:10 GMT -5
This will probably be the most views they've ever had for an article.
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Post by akemp3000 on Aug 29, 2019 14:27:46 GMT -5
All of the references for the article are at least ten years old which was after Pfizer had already pulled Exhubera from the market. IMO, IF this is being resurrected by competition to confuse the issue of inhaled insulin, it would be a sign they're becoming concerned. The door to acceptance seems to finally be cracking open within the medical community. Hopefully, the billboard campaign and scripts will begin showing results soon.
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Post by nylefty on Aug 29, 2019 14:50:25 GMT -5
All of the references for the article are at least ten years old which was after Pfizer had already pulled Exhubera from the market. IMO, IF this is being resurrected by competition to confuse the issue of inhaled insulin, it would be a sign they're becoming concerned. The door to acceptance seems to finally be cracking open within the medical community. Hopefully, the billboard campaign and scripts will begin showing results soon. Isn't the billboard campaign confined (so far) to a couple of markets in Texas?
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Post by Clement on Aug 29, 2019 14:58:47 GMT -5
"Dr. Mehta returned to practice in India in October 2012."
India .... hmmm. Cipla. Trials starting soon for Afrezza in India. Is Cipla already making some noise? Would a doctor attempt to position himself/herself as an experienced researcher in inhalable insulin (she already did the hard work more than 10 years ago and is indeed super-qualified), considering what's going on now with Afrezza in India? Damn, I would.
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Post by mnkdfann on Aug 29, 2019 18:39:14 GMT -5
More than likely, it was just an old paper the authors had been trying to publish in a better journal for years. Then, after many rejections, from a bunch of better journals, they sent their paper to this second or third rate journal.
It is not a fake journal, and some papers in MDPI journals are quite good. Appearing in a MDPI journal does not automatically make a paper bad or useless.
Probably other better journals just weren't interested in a paper describing an old study of a product that is by now off the market.
My guess is that the only reason Afrezza even got a mention is that the authors made a minimal effort to update the paper so some referee might find the paper slightly more topical and timely.
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Post by peppy on Sept 2, 2019 9:52:11 GMT -5
BlisterStorage: Not in-use (Unopened): Store at controlled room temperature, 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate.In-use: Once the foil overwrap is opened, unit dose blisters should be protected from moisture, stored at 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate. Unit dose blisters should be used within 3 months after opening the foil overwrap. Return the blisters to the overwrap to protect from www.accessdata.fda.gov/drugsatfda_docs/label/2006/021868lbl.pdfEXUBERA (insulin human [rDNA origin]) Inhalation Powder is a white to off-whitepowder in a unit dose blister (fill mass, see Table 1). Each unit dose blister of EXUBERA contains a 1 mg or 3 mg dose of insulin (see Table 1) in a homogeneous powder formulation containing sodium citrate (dihydrate), mannitol, glycine, and sodium hydroxide. After an EXUBERA blister is inserted into the inhaler, the patient pumps the handle of the inhaler and then presses a button, causing the blister to be pierced. The insulin inhalation powder is then dispersed into the chamber, allowing the patient to inhale the aerosolized powder. www.accessdata.fda.gov/drugsatfda_docs/label/2006/021868lbl.pdfDid you see the respiratory track infection rates of exubera? agedhippie shawnonafrezza . ? Do you see the stated respiratory track infection rates with subq? Pharyngitis? Thoughts?
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Post by shawnonafrezza on Sept 2, 2019 10:00:53 GMT -5
Only thought is how did they do the comparison to subq? I've never heard of any of those symptoms with shots. 6% chance of infection it really high for something you'll never read about anywhere.
If you're asking my thoughts on Exubera, I don't think Aferzza would have to worry. Exubera (from my talking to people, I never used it) was a PITA to dose and the device was large.
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Post by brentie on Sept 2, 2019 10:34:42 GMT -5
Only thought is how did they do the comparison to subq? I've never heard of any of those symptoms with shots. 6% chance of infection it really high for something you'll never read about anywhere. If you're asking my thoughts on Exubera, I don't think Aferzza would have to worry. Exubera (from my talking to people, I never used it) was a PITA to dose and the device was large.Ya think...
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Post by mannmade on Sept 2, 2019 11:16:41 GMT -5
Bong or dong! LOL!
That picture is from the way back machine Brentie! Ah the good old days when we all thought we had a blockbuster in fromt of us... Now for the slow grind up! GLTAL's!!!!!
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Post by agedhippie on Sept 2, 2019 14:53:03 GMT -5
... Did you see the respiratory track infection rates of exubera? agedhippie shawnonafrezza . ? Do you see the stated respiratory track infection rates with subq? Pharyngitis? Thoughts? My thought is that there is something else going on there. The problem is that when numbers get this small it's hard to assign weight to them. For example; taking those Type 2 figures at face value you are more likely to get a cough as a SC user than you are as an Exubera user which seems unlikely.
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Post by uvula on Sept 2, 2019 17:11:55 GMT -5
Interesting (but irrelevant ) that exubera did not need to be refrigerated but mnkd was never able or interested in obtaining the same designation for afrezza. This would be huge for India.
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Post by agedhippie on Sept 2, 2019 19:15:55 GMT -5
Interesting (but irrelevant ) that exubera did not need to be refrigerated but mnkd was never able or interested in obtaining the same designation for afrezza. This would be huge for India. More explicitly, it says do not freeze or refrigerate for both in use and in storage. Guess they did the work to get the designation.
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Post by sayhey24 on Sept 2, 2019 19:24:38 GMT -5
When I read the study at first, I just assumed because it talked about inhaled insulin, it was about Afrezza. Then I realized it was about Exubera. I haven’t seen Exubera mentioned in a long while. What does this mean? I think it means that inhaled insulin is beginning to take off and that anything inhaled is worth a second look. Who knows. What it does is put "Afrezza", "inhaled" and "Exubera" together. I don't feel that association with Exubera, a failed inhaled insulin, is good for Afrezza. Was Exubera really a "failed" inhaled insulin or did Pfizer make a business decision not to make the market for afrezza knowing how much better afrezza was and how disruptive it would have been to the market, if the market was all a buzz about the inhaled insulin miracle Exubera? A few years back I had the chance to talk with the lead scientist for Exubera. He told me it was the latter and told me the cancer scare was a made up scare to soar the market for afrezza. His words not mine. He was also one of the most knowledgeable people I have talk to about afrezza. I will say they did a hell of a job soaring the market. This is an interesting study. The one big thing afrezza and Exubera share is they eliminate all the subq issues. The benefits shown in this study would also apply for afrezza. I like it.
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