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Post by mannmade on Oct 7, 2016 16:09:52 GMT -5
Saw the headline on a news alert but could not get the article. Will shortly if someone else does not. But looks like Mylan is paying a $485m fine. Hmm... Wonder what's next?
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Post by mannmade on Oct 7, 2016 15:59:49 GMT -5
Ok - likely a REALLY dumb idea but --- i suspect a lot of folks have a lot of money on the line with this stock. I know I do - way more than i should have but i like many here really believe in the science. The challenge is that the company is handcuffed to be able to advertise the REAL benefits of the drug! I am thinking ---- if a bunch of people got together and chipped in to have ads placed on TV and told the REAL story about Afrezza - would it help or hinder? Would it even be possible or even legal if Mannkind was NOT involved??? Dumb idea??? you can reach alot more people and alot cheaper if you buy video ads online. Facebook video and Youtube ads go for about 2-5 cents per view. And we are talking about targeted views here too, where you can target the keyword diabetes or in contextual areas where insulin or diabetes are mentioned. TV commercials are expensive and less effective. Mannkind should be doing this themselves. It's not that expensive as everyone makes it out to be. Their agency should be advising this to them but sadly they have chosen to once again forego direct to consumer and reach out to physicians. I believe this is what Matt P was talking about as part of their DTC campaign.
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Post by mannmade on Oct 7, 2016 1:27:45 GMT -5
www.fool.com/investing/2016/10/01/this-could-be-the-biggest-breakthrough-ever-for-th.aspxThis Could Be the Biggest Breakthrough Ever for the 1.25 Million People With Type 1 Diabetes The FDA just approved a first-of-its-kind device, and it should make life a whole lot better for type 1 diabetics. Sean Williams (TMFUltraLong) Oct 1, 2016 at 2:18PM Type IMAGE SOURCE: GETTY IMAGES. Often referred to as the "silent killer," diabetes in the U.S. is soaring. As of 2012, 29 million people had diabetes, up from 26 million in 2010. The majority were type 2 diabetics, which means their disease, which is caused by the body's inability to use insulin properly to convert sugar into energy, develops over time. Type 2 diabetics and prediabetics are often encouraged to change their eating and exercise habits to slow the progression of their disease. Type 1 diabetes is no laughing matter A much smaller percentage of the population -- 1.25 million children and adults -- have what's known as type 1 diabetes. Those with type 1 diabetes have little to no insulin production from their pancreas, and as the Mayo Clinic notes, it's often caused by genetics or perhaps exposure to specific viruses. Type 1 diabetics also, according to a recent study in Australia between 1997-2003 and 2004-2010, have a life expectancy that's 12.2 years less than the general population. Woman With Glucometer Diabetes Testing Blood Getty IMAGE SOURCE: GETTY IMAGES. The overwhelming number of type 2 diabetes cases compared with type 1 often seems to overshadow the seriousness of type 1 diabetes, as well as the struggles and inconveniences type 1 diabetics face in constantly monitoring their blood sugar levels. Per Reuters, more than a third of type 1 diabetics are utilizing an insulin pump to help regulate their blood sugar. Life as a type 1 diabetic isn't easy. However, that could be about to change thanks to what could be described as the biggest breakthrough ever gaining clearance well ahead of schedule from the U.S. Food and Drug Administration. The biggest breakthrough ever for type 1 diabetics As announced by medical device powerhouse Medtronic (NYSE:MDT) on Wednesday, the FDA has approved the company's "artificial pancreas" device known as the MiniMed 670G six months ahead of schedule. The device is the world's first closed loop system to be approved by a regulatory agency – which is no small feat considering that European regulators almost always beat U.S. regulators to approval. Minimed MINIMED 670G. IMAGE SOURCE: MEDTRONIC. The device, which was approved for those aged 14 and up, measures a patient's blood glucose levels every five minutes and administers insulin on an as-needed basis. The device uses a sensor with a protruding needle that's slipped under the skin and measures insulin levels, while a smartphone-sized insulin pump worn on the abdomen delivers the insulin via tubes that lead to a catheter. Is it perfect? Not exactly. Users will still have to instruct the device to deliver extra insulin during meal time, and will have to make adjustments when exercising, which can affect insulin levels. Additionally, patients must recalibrate the device every 12 hours, change out the glucose sensor on a weekly basis, and refill their insulin reservoir every three days. But, compared to the frequent number of times type 1 diabetics are required to check their blood sugar levels daily, this is a major improvement. In particular, the study that led to the MiniMed 670G being approved tested the device on more than 10-dozen patients. Following the conclusion of the study, the average HbA1c blood sugar level of the patients had fallen from a baseline of 7.4% to 6.9%, with nearly 3 in 5 patients (58%) achieving an HbA1c below 7%. Finer points for consumers and investors to keep in mind It's worth pointing out that even with the surprisingly early approval, the MiniMed 670G won't be available until spring of 2017, which is subsequently when it's likely to gain approval in Europe. Also absent was any pricing expectations from Medtronic concerning this revolutionary closed loop system. Jefferies' covering analyst Raj Denhoy is estimating a cost of between $5,000 and $8,000 for the device, with the disposable sensors costing an additional "few thousand dollars" a year. I don't foresee Medtronic having issues getting insurance covering for its game-changing device, but the added expense associated with the MiniMed 670G could price some consumers out of purchasing the device. Stethoscope Over Money Healthcare Costs Obamacare Getty IMAGE SOURCE: GETTY IMAGES. Medtronic is also likely to maintain its pricing power for the immediate future with its MiniMed 670G since competitors DexCom (NASDAQ:DXCM), which is known for its glucose monitoring devices, and Johnson & Johnson, are still years away from potentially bringing a closed loop system to market. It's possible DexCom could actually lose what market share it's gained because of Medtronic's major advancement in personalized type 1 diabetes care. Just how big could the MiniMed 670G be? JDRF estimates that annual type 1 diabetes costs tally about $14 billion. While it's tough to estimate how well the MiniMed 670G could fare without exact pricing and insurer coverage information, an assumption of $1 billion-plus in annual sales as its peak seems achievable. But most importantly, type 1 diabetics are just months away from gaining access to a device that could greatly improve their quality of care and reduce their chances of a hypoglycemic event.
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Post by mannmade on Oct 6, 2016 19:13:29 GMT -5
His understanding of MannKind and AFREZZA was very simplistic and he pretty much repeated the same thing in every article he authored. He never offered any real research regarding his opinions.
My sense is as stated above, just click bait and the people stopped biting... time to move on...
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Post by mannmade on Oct 6, 2016 18:29:16 GMT -5
He'll be back...😎
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Post by mannmade on Oct 6, 2016 11:11:23 GMT -5
www.voanews.com/a/scientists-find-more-accurate-method-test-blood-sugar-levels/3538489.htmlHEALTH Scientists Find More Accurate Way to Test Blood Sugar Levels October 05, 2016 7:00 PM Jessica Berman FILE - Judith Garcia, 19, fills a syringe as she prepares to give herself an injection of insulin at her home in Commerce, California, April 29, 2012 FILE - Judith Garcia, 19, fills a syringe as she prepares to give herself an injection of insulin at her home in Commerce, California, April 29, 2012 Share Print See comments In one-third of people with diabetes, the "gold standard" method for monitoring blood sugar levels is inaccurate. But scientists have found a way to fix the discrepancy, helping diabetics more effectively manage their disease. There are 422 million people with diabetes worldwide, according to World Health Organization estimates, and they face such devastating complications of the disease as blindness, kidney failure, heart disease and limb amputation. Keeping blood sugar levels in a range that's as close to normal as possible is considered the best way to reduce the likelihood that a diabetic will have to deal with those complications. But researchers from Harvard Medical School and Massachusetts General Hospital found in a study of 200 diabetics that the A1C test, considered the most accurate method for measuring glucose levels, is inaccurate in one in three people. Three-month period The A1C offers a snapshot of blood sugar levels based on a three-month analysis of glycated hemoglobin, or the hemoglobin to which glucose is bound. The test is considered more accurate than daily blood sugar levels, which can vary minute by minute. FILE - A woman who suffers from diabetes is seen walking on a treadmill as part of an exercise program to help control the disease. FILE - A woman who suffers from diabetes is seen walking on a treadmill as part of an exercise program to help control the disease. But when scientists compared daily glucose monitoring to the A1C, they found discrepancies based on the age of the red blood cells, according to John Higgins, a professor of systems medicine at Harvard and a clinical pathologist. Red blood cells live an average of 45 days. But they live longer in some people, prompting this comparison by Higgins. "I think a simplistic analogy is just a sponge sitting on a damp counter," he said. "The more water you have on your counter, the more soaked that sponge is going to get. But also if you leave that sponge on a counter even longer, it's going to soak up even more water." So, the A1C level of a person whose blood sugar seems well-controlled day to day may actually be elevated if his red blood cells are older. "And the opposite is true as well," said Higgins. "If someone has had a really high level of blood sugar but his blood cells are pretty young, it may look like he is fine when in fact his blood sugar's been high." FILE - A Novo Nordisk employee controls a machine at an insulin production line in a plant in Kalundborg, Denmark, Nov. 4, 2013. FILE - A Novo Nordisk employee controls a machine at an insulin production line in a plant in Kalundborg, Denmark, Nov. 4, 2013. When the age of each person's red blood cells was factored in, the error rate in the A1C's three-month blood sugar reading was cut in half in the study. The findings were reported in the journal Science Translational Medicine. Continuous measurement One way to correct for the discrepancy, according to Higgins, would be for someone to briefly wear a device that continuously measures blood sugar level. The device, which uses a needle implanted under the skin, takes glucose readings every five minutes. Those hundreds of readings could then be compared with an A1C reading. With the data, the difference between daily blood sugar levels and the A1C level could be permanently corrected for in the lab. By factoring in the age of each patient's red blood cells, the method offers a more precise, individualized method of diabetes control. Most people think of personalized medicine as involving sophisticated, expensive genetics tests that help doctors tailor treatments for complex diseases. Higgins said adjusting a test for A1C is a form of personalized medicine using everyday lab tests. "I think this study shows that we can look at laboratory tests that are already being collected and measured," he said. "And if we think mathematically about the physiology leading to those measurements, we can personalize monitoring and treatment of some of these diseases already."
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Post by mannmade on Oct 5, 2016 21:58:00 GMT -5
How about some angel investors? 😊
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Post by mannmade on Oct 5, 2016 15:31:52 GMT -5
The original link provided above worked for me very easily...
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Post by mannmade on Oct 4, 2016 12:54:18 GMT -5
www.news-medical.net/news/20161004/Diabetes-patients-do-not-absorb-insulin-effectively-when-injecting-into-lipohypertrophy-confirm-new-studies.aspxDiabetes patients do not absorb insulin effectively when injecting into lipohypertrophy, confirm new studies Published on October 4, 2016 at 9:00 AM · No Comments inShare Share1 Two new studies provide evidence for the first time that insulin is not absorbed effectively when injected into Lipohypertrophy (LH). LH has long been associated with poor insulin absorption; in a 2013 study, 39.1% of participants with LH had unexplained hypoglycaemia, compared to 5.9% without, but this is the first time the link has been proven. The Glucose ‘Clamp’ study was conducted by Famulla et al, who concluded that ‘Lipohypertrophy leads to blunted, more variable insulin absorption and action’. In this study, a clamp was used to maintain blood glucose concentration for 24 hours in all subjects, followed by regular insulin injections into LH or normal tissue. When injected into LH, the insulin concentration in the blood stream was 37% lower in the first four hours and the maximum insulin concentration was 34% lower. When injected into LH, there was a 27% reduction in Glucose Infusion Rate. These results show that insulin absorption and action from LH are considerably less reliable than from healthy tissue. Related Stories FDA approves automated insulin delivery device for type 1 diabetes Certain fatty acids may increase diabetes risk in women, study finds Fat stem cells can lower risk of diabetes in healthy obese individuals Conducted by Hövelmann et al, the Mixed Meal tolerance test study saw all participants given exactly the same food meals. Prior to eating, insulin was injected into normal tissue for one meal and into LH for the other to measure blood glucose concentration and insulin absorption. Insulin activity within the first five hours was reduced by 46% when injecting into LH. Post-meal blood glucose concentrations significantly increased when injecting insulin into LH, whereas injecting into normal tissue lead to a 25% post-meal glucose reduction. Maximum blood glucose concentration was also reached 15 minutes later when injecting into LH. The study authors concluded that insulin injection into LH impairs insulin absorption leading to deterioration in after meal blood glucose control. People with diabetes can help to avoid lipohypertrophy through good injection technique; evidence suggests that those who suffer from LH tend to fail to rotate injection sites on a regular basis, inject into small injection zones and engage in needle re-use. These aspects of good injection technique, along with the use of 4mm pen needles, also help to reduce erratic insulin absorption and glycaemic variability.
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Post by mannmade on Oct 3, 2016 16:10:14 GMT -5
It's likely the character walked the grounds of the event to take pictures with all participants...
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Post by mannmade on Oct 3, 2016 15:43:44 GMT -5
Not wanting to take a side in this discussion one way or the other, I have been curious why the past few days in the face of down weekly script numbers we have had two up days in a row for the first time in several weeks... My only thought so far is when you expect Mnkd to zig it zags... (An homage to RSL whoever they may be...) Cheers!
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Post by mannmade on Oct 3, 2016 13:05:08 GMT -5
www.cheatsheet.com/health-fitness/rx-meds-dangerous-side-effects.html/?ref=YF&yptr=yahooType 2 diabetes: How one mistake led a man to lose a foot 9 hours ago Warning: Contains images some may find upsetting On average in 2014-15, 185 operations were carried out every week in the UK to amputate the limbs of people with complications linked to diabetes. One particular symptom of the condition is loss of sensation in the feet. Also wounds in lower limbs don't heal up properly because clogged arteries restrict the flow of blood to the injury. That can lead to gangrene which can be fatal. For more information watch Panorama, The Hidden Killer, on Monday at 20:30 BST - catch up on BBC iPlayer
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Post by mannmade on Oct 2, 2016 18:18:45 GMT -5
Thanks for sharing. this is The kind of things i like to see. unfortunately, before we get international approval, i could be very old LOL (humor) op Just imagine what the current AFREZZA label would look like there... 😊🙏
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Post by mannmade on Oct 2, 2016 17:57:11 GMT -5
www.yahoo.com/news/big-pharma-vs-big-pharma-court-battles-over-091414668--finance.htmlBusiness Big Pharma vs Big Pharma in court battles over biosimilar drugs By John Miller,Reuters 13 hours ago By John Miller ZURICH (Reuters) - The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals' complex biological medicines. These drugmakers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars - biopharmaceutical drugs with the treatment properties of medicines they seek to mimic - while simultaneously challenging rivals' patent claims. Biologics, manufactured in living cells, then extracted and purified, are more complex than traditional medicines and cannot be copied with precision, and so their knock-off versions are called biosimilars instead of generics. The allure of biosimilars is clear, with insurers and other payers counting on the steep discounts. U.S. pharmacy benefit managers are already trimming brand-name drugs from their rosters. With Novartis Chief Executive Joe Jimenez predicting biosimilar discounts of up to 75 percent, in part based on developments in Europe, makers of innovative drugs are fighting tooth and nail to protect their higher-priced products for as long as possible. [ For instance, AbbVie has sued in Delaware claiming patent protection for its arthritis drug Humira, the world's best-selling prescription medicine, until at least 2022 as it seeks to delay an Amgen replica that won U.S. approval last week. Meanwhile, Amgen has gone to another U.S. federal court seeking to protect its own arthritis medicine, Enbrel, from a Novartis biosimilar until 2029. With lawsuits pitting Big Pharma against Big Pharma piling up, lawyers said the legal landscape has gotten a lot more complex. "One of the biggest surprises has been the number of innovator biopharma companies, like Amgen, now developing biosimilars to compete with the products of other innovator companies," said Don Ware, an expert on biosimilars at U.S. law firm Foley Hoag in Boston. “This creates conflicts for law firms like ours, because suddenly the clients we advise are adverse to each other," Ware said. "And it makes it hard for the companies to retain top outside counsel without having to give them conflict waivers.” Sanofi, Merck, Eli Lilly, Pfizer, Johnson & Johnson and Biogen are also embroiled in lawsuits over biosimilars. NOT BITTER ENEMIES Even so, some analysts say the lawsuits are business as usual and are unlikely to spill over into other areas, including research partnerships. Novartis and Amgen may be at each other's throats in court over the Swiss drugmaker's Enbrel copy, but the two are still cooperating on a drug for migraines. "It's not like these companies are bitter enemies," Zuercher Kantonalbank analyst Michael Nawrath said. "These court cases are simply the last resort of original drug makers to wring a few more months or a year of exclusivity from their blockbusters." Conflicts pitting big drugmakers against each other may have been inevitable after Europe in 2006 and the United States in 2010 created separate biosimilar approval rules. After all, Big Pharma's financial clout and expertise made large, sophisticated drugmakers the natural candidates to manufacture complex biosimilar copies that cost hundreds of millions to bring to market, far more than for generic off-patent copies of simpler, small molecule drugs. Some smaller companies and generics makers have jettisoned biosimilar programs after originally underestimating hurdles to entry, Richard Francis, head of Novartis's Sandoz division that makes biosimilars, said earlier this year. Just this week, Shire abandoned two biosimilar candidate drugs that accompanied its Baxalta takeover, copies of Amgen's Enbrel and AbbVie's Humira, to focus on rare diseases. "The realization of what it's going to take to stay in this market and be successful has led to a change in the landscape and the players in it," Francis said.
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Post by mannmade on Oct 1, 2016 17:34:19 GMT -5
I'm pretty sure one person can have and easily manage two twitter accounts. She has made to clear she is going to talk about what ever she wants. We are both Trump fans and I agree with her. It won't last that much longer anyway:-) @beyouonlybetter: @andersonpfef I'm an advocate for all I have passion for.The press shows favoritism to Clinton & bias towards Trump,I can't sit back & watch! Let's ask Matt Laurer about bias...
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