Diabetes Care ADA Journal: Affinity 1 Result By Dr. Bode
Afrezza Second Launch 9/29 w/ 12u, 3 Lines, Published Affinity 1, 2 Results, 10 days after Sanofi-Afrezza National at MGM Grand Ballroom finishes on 9/18.
Roberta Dey said today BoD will convene this Nov to decide on TS partners. Mnkd must have figured out optimal API for PAH, Pain Meds.
Brian Lynch @nccapitalist
My endocrinologist writes Afrezza scripts for over 30 patients. He is an Afrezza believer. Why would he be the exception and not the rule?
6:57 AM - 12 Sep 2015
Dr. Alan Marcus, a diabetes doctor in Laguna Hills, said he has followed the drug's development for more than a decade.
In three months, he's already prescribed the drug to about 30 patients. "They love it," he said. "It allows them to control their glucose ... in a manner that doesn't stigmatize. If you're out at a restaurant, the last thing you want to do is go to the bathroom for an injection or stick a needle through your clothing."
But unless something is done to make it easier to get the drug into patients' hands, doctors will probably be reluctant to prescribe it, Marcus said.
"It's not an easy prescription," he said. "They have to go through testing. Then you have to take a moment to demonstrate it. Then you have to deal with the insurance companies. Then you have to deal with the pharmacists, because most of the pharmacies don't have it in stock. This is a process that takes a lot of time, it takes a lot of effort."
Quoted from MannKind's inhaled insulin drug proves hard for diabetics to get (Published on 3 June 2015 on latimesDOTcom).
Event: "Sanofi-Afrezza National" (verbatim)
Date: 9/14-18/2015 Next Mon-Fri
Where: MGM Grand Grand BallRoom 61,575 sq ft in CONFERENCE CENTER LEVEL 1, Las Vegas
Status: Confirmed w/ Concierge
After testing 18 different dose permutations of Lantus, I remained disappointed with my glucose levels between meals. Switching to Levemir improved things greatly, but introduced new problems each day.
A new basal called Toujeo contains identical ingredients to Lantus and still seems to be inconsistent in its release. This study observed 50 people for 2 days on Toujeo. This figure shows that Toujeo’s release sometimes varied considerably between the two days and did not always lower glucose steadily throughout the day – its activity sometimes spiked or ran out.
That study was by the manufacturer of Toujeo and Lantus. Another study by its competitor showed that Lantus was over 300% more variable in its release over 24 hours than the new ultralong acting basal Tresiba.
They calculated the risk of experiencing more than double the usual maximum effect on any given day (potential hypoglycaemia) was
Sanofi Breakthrough 2.0 - MGM Las Vegas
I spoke to Matt last week (Wed 9/16/15), and he confirmed that SNY was having training in Vegas this week. He is currently in Europe at the EASD. Will be back on the 25th. It is my understanding that the SNY reps that call on GP's will be having their own training soon. I believe that David Kliff was spreading FUD claiming that 2/3 of the reps that were training this week were being asked not to attend. SNY made a decision to have the GP reps, the 2/3 in question (700) have training at their own meeting, since they already had a meeting coming up.
Matt will attend 9/22 JAC in Paris.
Brendan’s Story of Hope in the UK
This week I planned on finally finishing the Week 20 summary as well as a few other projects I have going, but someone touched my life a few months ago and he tweeted some special news, and so I wanted to devote my time to something even more important than an excellent diabetes summary . It is a story about an unexpected life changing moment for both of us that happened around the same time. This is the story of my friend Brendan.
Most people who follow me know that my sister was terminally ill and I flew to England to be with her in her final hours of her life some months ago. It was on very short notice that I decided to make the trip. As many of you know my web site has been read in about 130 countries and I receive emails from around the world. I try to find the time to read and reply to most of them but obviously with what was going on with my sister I had plenty of other things on my mind. However, at exactly the same time I was going to England, I received a very touching email from a person in the UK named Brendan Hyland who is a type 1 diabetic, diagnosed almost 30 years ago and he was looking for help and feeling like giving up. He explained that he watched my interview with Emily Coles on the internet and that we had many similarities in our diabetic journey and he wanted to know if Afrezza works as good as I say it does.
Brendan’s A1C is around 7 or so which is fairly controlled, but as he explained to me, he suffers from “massive swings” in his BG control–from extreme lows near 36 to highs around 450–and it was wreaking havoc on his business and personal life. He had tried insulin pumps on 2 different occasions and neither worked very well for him. He was constantly exhausted from babysitting his diabetes around meals and also at bedtime, leaving him completely tired and struggling with his everyday activities, and just being able to perform his job was a huge battle. It could have been the wild blood glucose swings, the profuse sweating, the not being able to concentrate for long periods of time, or maybe it was the need to go to the bathroom when his blood sugars were high and not being able to skip out and take the 5 minutes to handle the situation — but things were getting to be too much to bear, and he realized that diabetes was winning the war. With all the worry about the toll diabetes was taking on his physical health, he also realized there is a tremendous mental health strain as well that not many people talk about. After all, you don’t see many people in diabetes magazines that look like either of us – he is 6 ft 3 in, and a very commanding individual who works out regularly and looks by all discerning eyes to be someone who couldn’t possibly have any issues or problems. But that is diabetes. With it comes all the terrible emotions and side work no one else can imagine or even see.
At the same time of Brendan’s email, my sister, who lived in England and was losing her battle with Breast Cancer and struggling to prepare her 3 kids (all under 10) and her husband for life without her, little did I know that out of this deep loss I would be gaining a new friend, Brendan. My sisters husband was kind enough to welcome Brendan to come visit at their house in the midst of our grief after hearing about his situation, and although he was in route to meet all of us in person that day, after 4 hours of traffic due to a national strike and holiday, he decided it would be safer and easier to speak via telephone, and that time of exchanging stories forever deepened our friendship. We continue speaking to this day and although we haven’t officially met in person, I’m proud to report Brendan is now on Afrezza. And so far so good. Best of all, he now has more hope, confidence and spends less than worrying and more time living and it’s only his first week.
Screenshot_9_3_15__12_16_PM brendan afrezza
As we all wait for that eventual good news of approvals around the world, I think it’s an appropriate time to remember that there are real, hurting people like Brendan doing their very best to live a “normal” life and are desperate for what Afrezza can do for them. And not just in England either. The US Market is still relatively unaware that Afrezza the “real-time” solution even exists, yet as Afrezza Users we know that will all change very soon with Sanofi’s ever-increasing presence, slowly increasing advertising campaign and continued success stories like Brendan and the hundreds of others.
I would like to give a special shout out today to all the Sanofi Sales Reps who do the very challenging job of educating doctors, diabetes educators and others day in and day out on a drug that saves lives in a medical environment that sometimes resists anything new, different or paradigm-changing. Please know how much all of us Afrezza Users consider you “heroes” for what you do to help diabetics and appreciate all your efforts. There is truly nothing in the world like Afrezza–and doctors really need to know that! Afrezza does more than improve A1C Levels–its gives us our time and our life back, and in the process, it makes us feel completely “normal” again. Thank you for going the extra mile and doing your best–you are saving lives and we will hear of many more “life-changing” examples in the future because of what you are doing today!
Please keep Brendan in your thoughts and prayers on his Afrezza journey and feel free to send him a line of encouragement. Out of a loss there always comes rays of light into your life–and Brendan for me is one other those bright, passionate people who inspires others, and I wish him every success on the drug that also saved my life–Afrezza. Welcome to the Afrezza Family Brendan, and we look forward to hearing more about your experience and also to see you spreading the word to the entire UK about how this new “life-changing” drug works for you! Go UK AU!
Dry powder inhalable compositions and methods for using and making the compositions are disclosed for vaccinating a subject against disease. In particular, the compositions are inhalable dry powders useful for preventing and/or treating diseases caused by microorganisms, for example, microorganisms such as viral or bacterial pathogens, including, the influenza virus. In particular, the method comprises the administration of an inhalable composition comprising virus-like particles and/or specific protein/s or antigenic peptides, peptide fragments and/or derivatives thereof using a dry powder drug delivery system.
Information currently unavailable.
Mannkind Corp Technovax Inc
Smutney Chad C Leone-Bay Andrea Galarza Jose M Munoz Hector Martin George R Grant Marshall L
A61K2039/544 A61K2039/55555 A61K39/07 A61K39/12 A61K39/145 A61K9/0075 C12N2760/16134
A61K39/12 A61K39/145 A61K9/00 A61P31/16
Sep 2, 2015 EP_2911690_A1
Oct 25, 2013 EP_13786858_A
Oct 25, 2013 US_2013_0066969_W
Oct 26, 2012 US_201261719308_P
Afrezza: Timing is everything
Diabetes: “Timing is Everything” - Mannkind Corp
This video covers my experiences with Afrezza dose timing, and why I think timing is the most important aspect of dosing – even more important than the size.
This video covers my experiences with Afrezza dose timing, and why I think timing is the most important aspect of dosing – even more important than the size.
I have previously mentioned the importance of dosage timing when taking Afrezza, but have not gone into much detail. So I thought it would be worthwhile talking about what I have learned so far about timing.
As a general rule, I dose about 10 minutes after I start eating, which is before my glucose levels start to rise from the meal. As I mention in the video, the best time to dose seems to depend on the fat content of the meal. And for some high fat meals, a follow up dose of Afrezza is neccesary.
I have found the same rule also applies if a follow-up dose is required. It is important to have the follow-up dose before the levels begin to rise out of range. If I had a CGM with alerts, I would use this to notify me as soon as it levels began to increase. That way I wouldn’t miss the optimum time for the follow-up.
It is worth remembering that much, much more Afrezza is needed to correct high glucose levels than to cover meals. As the video details, if I wait too long to dose, the dose required may be four times higher!
Afrezza Lowers HbA1C in Uncontrolled Type 2 Diabetes
Published Online: Monday, August 31, 2015
Adding Afrezza insulin inhalation powder to oral diabetes medications significantly reduces HbA1C in adults with poorly controlled type 2 diabetes.
To arrive at this conclusion, researchers recently examined more than 350 adults with type 2 diabetes and HbA1C levels between 7.5% and 10% who were taking metformin alone or at least 2 oral antidiabetes agents.
As an add-on to their oral regimen for 24 weeks, roughly half of the patients were randomly assigned to receive Afrezza, a prandial Technosphere inhaled insulin approved by the Food and Drug Administration (FDA) in June 2014 and launched by Sanofi and MannKind Corp in February 2015, while the remaining participants received prandial Technosphere inhaled placebo for the same time period.
Afrezza doses were titrated weekly based on glucose levels for the first 12 weeks to target 90-minute postprandial glucose levels of 110 mg/dL to 160 mg/dL. The participants could take a supplemental dose if their 90-minute postprandial glucose level was at least 180 mg/dL. For the remaining 12 weeks of the study, the researchers only adjusted doses for safety concerns.
The study results showed that Afrezza treatment reduced HbA1C by 0.8% from 8.3% at baseline, compared with the placebo’s 0.4% decrease in HbA1C from baseline. Significantly more inhaled insulin participants also achieved an HbA1C of less than or equal 7% than the placebo group.
As for changes in weight, the inhaled insulin group gained an average of 0.5 kg, while the placebo group lost an average of 1.1 kg.
Both participant groups experienced respiratory adverse events, the most common of which was a mild, dry cough (23.7% in the insulin group and 19.9% in the placebo group) that caused 1.1% of the insulin group and 3.4% of the placebo group to discontinue treatment in the study.
This treatment discontinuation resolved the slightly larger decline in forced expiratory volume in 1s that was seen in the Afrezza group compared with the placebo participants.
- See more at: pharmacytimesDOTcom/news/afrezza-lowers-hba1c-in-uncontrolled-type-2-diabetes#sthash.iH1dBypu.TzYZ5T8R.dpuf
Affinity 2 Results.
New tweet with link to article. Enjoy.
"Inhaled insulin therapy reduces HbA1c in poorly controlled type 2 diabetes"
Endocrine Today @EndocrineToday 19m19 minutes ago
#Afrezza therapy reduced HbA1c in poorly controlled #T2D http://ow.ly/QOVPo
Donald Trump blasted Martin Shkreli — the now infamous pharmaceutical CEO — on Wednesday for raising the price of a drug used by AIDS patients from $13.50 to $750 per pill.
While stumping in South Carolina, Trump said, "This young guy raised the price to a level that’s absolutely ridiculous, and he looks like a spoiled brat to me."
Read More Donald Trump Touts Stephen Colbert Ratings in Beef With Fox News
The GOP front-runner called Shkreli a "hedge-fund guy," and added, "I thought it was a disgusting thing, what he did. I thought it was a disgrace."
The reporter who asked Trump's opinion on ShkreliI interjected and said that there are many drugs with prices too steep for the people in need.
"I know, it’s terrible, but in particular, there’s something about that one, the way he raised it and to that extent and then he sat back smug like he was hot stuff," Trump said. "That guy is nothing. He's zero. He's nothing. He ought to be ashamed of himself."
The former Apprentice host said he believes public outcry would make a difference.
"I think probably at some point the public is going to get him to reduce it somewhat, but I think what he did was a disgrace," Trump said. "I thought it was a disgrace."
Read Trump's full statement below:
"This young guy raised the price to a level that’s absolutely ridiculous, and he looks like a spoiled brat to me. You want to know the truth? He looks like a spoiled brat. And he's a hedge-fund guy, who, as you know, the only one that I'm raising taxes on. They are going to be paying up. But I thought it was a disgusting thing, what he did. I thought it was a disgrace. I know, it’s terrible, but in particular, there’s something about that one, the way he raised it and to that extent and then he sat back smug like he was hot stuff. That guy is nothing. He's zero. He's nothing. He ought to be ashamed of himself. And I think probably, at some point, the public is going to get him to reduce it somewhat, but I think what he did was a disgrace ... I thought it was a disgrace."
BofA To Return 9M shares this Fri 10/16, 45 biz days after 8/15 Notes closing.
932 Reduced hypoglycaemia is observed with inhaled insulin versus subcutaneous insulin aspart in patients with type 1 diabetes mellitus E. Nikonova, B. Bode, J. Gill, J. Stewart, L. Blonde, USA, Canada
liane said:Wow - 1st euglycemic ketoacidosis, now osteoporotic bone fractures. Not to mention UTI's. Sounds like a drug I would love to try (not!).
So sanofi reps CANT claim ultra rapid as of now, but it would seem they could bring up these points regarding other drugs?
The official event name is "Sanofi-Afrezza National". Thus, it must have Afrezza training. You can quadruple-check by calling MGM Grand Concierge.
The official name is "Sanofi-Afrezza National" posted here many times. Call MGM Grand Concierge to verify. It's in the Grand Ballroom. Why Speculate? Your motive? Or just lazy?
51st EASD Stockholm 9/14-18/2015 next week.
4,450,300 share Block Buy at $3.46 @ 3:59 P EST on 9/18 According to Yahoo interactive chart. It must be MF, Institution Buy, BofA, or Sanofi Buy-In?