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Post by mannmade on Sept 16, 2016 18:02:24 GMT -5
Swift boat? Nah too political... Motor Boat? Nope no motor..., Maybe Cigarette Boat (like the racers)? Nah, that will just bring up the cancer issue again... I personally like DreamBoat as in a dream come true... Cheers!
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Post by mannmade on Sept 16, 2016 12:20:58 GMT -5
I think it was because that's the time it took for Insulet to let MannKind know it was unacceptable to them and they considered it a violation of his separation agreement for non-compete. Guess that since he was more than adequately rewarded on the way out from Insulet that he did not want to risk nor did he like the idea of a protracted law suit and either did Mnkd.
I have posted here before why I believe Duane is not coming back (nor do I believe he should at this point) for the following reasons:
1. He did not hire Mike and his team and a new leader always likes to put in their own people for the most part especially at the most senior level where they are direct reports 2. Why would MannKind and where would MannKind get the money to pay him when they are strapped for cash at the moment? 3. We are only 2 1/2 months into the launch of MannKInd 2.0 and Duane is not going to want to come in and be a caretaker for someone else's business plan. Where's the credit for him in that? And there is no time to change the current plan and start over at this point. 4. Matt and Mike are doing a very good job with the resources they have. 5. It is my understanding that Duane left Insulet under some kind of cloud, although not sure what
Now what might make sense is to hire him as an executive consultant and just give him warrants or options.
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Post by mannmade on Sept 15, 2016 13:50:43 GMT -5
Study suggests pancreatic cancer could be detected early in patients with newly developed type 2 diabetes September 15, 2016 Study suggests pancreatic cancer could be detected early in patients with newly developed type 2 diabetes New research presented at this year's European Association for the Study of Diabetes (EASD) meeting in Munich, Germany (12-16 September) suggests that screening patients newly diagnosed with diabetes for pancreatic cancer could be an effective way of diagnosing and treating pancreatic cancer early.
The study is by Dr Pavel Škrha, Charles University, Prague, Czech Republic and colleagues. New-onset diabetes mellitus/prediabetes with duration of less than 2 years can be the earliest symptom of pancreatic cancer (PAC), especially when significant weight loss is present. Also, long-term diabetes (T2DM) is a risk factor for developing PAC. In this study, the authors' aim was to determine the sensitivity and specificity of the current biochemical marker CA 19-9 alone or together with promising new markers microRNA-196 and -200 in distinguishing PAC patients from non-cancer patients. A total of 60 PAC patients with DM (35 men/25 women, mean age 67 years), 34 Type 2 DM patients without PAC (27 men/7 women, mean age 63 yrs) and 30 controls (22 men/8 women, mean age 63 yrs) were enrolled in the study. Diagnosis of the cancer was confirmed either by needle biopsy or by surgical resection of the tumour. DM/prediabetes diagnosis was made according to American Diabetes Association criteria. CA 19-9 was performed routinely in a laboratory, while serum samples were used for microRNA isolation. The researchers found more patients with PAC were associated with new-onset diabetes than with long-term diabetes, with 44 of PAC patients having new-onset diabetes and 16 PAC patients having long-term diabetes, All three biomarkers were significantly elevated in PAC patients, with no difference in the subgroups according to the duration of diabetes. While sensitivity and specificity of CA 19-9 alone to detect the cancer was 85 % and 73 %, respectively, a combination of CA 19-9 and microRNA-196 and -200 improved sensitivity (the ability to diagnose correctly those with PAC) to 95 % and specificity (the ability to identify those without PAC) to 77 %. The authors say: "Higher detection of new-onset diabetes or prediabetes in pancreatic cancer could play an important role in the early diagnosis of this cancer which has some of the worst outcomes of any cancer. Other signs like weight loss and/or gastrointestinal symptoms may initiate further examination." They add: "Thanks to high sensitivity a combination of modern molecular markers microRNA-196 and -200 together with CA 19-9 could be used in the first line of non-invasive pancreatic cancer screening in patients with new-onset diabetes. It would reduce the delay in the diagnosis of pancreatic cancer and improve the prognosis of diabetic patients with this malignant disease."
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Post by mannmade on Sept 15, 2016 13:20:24 GMT -5
And an NP will take the time with each patient to teach them how to properly titrate...
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Post by mannmade on Sept 14, 2016 18:18:28 GMT -5
If I were the CEO of Mylan I would come to Congress bearing gifts... Namely a deal with MannKind to include the value add of a cricket with epi for free with the pens and then also offer separately as a lower cost alternative... They are going to need some help here... Especially on an election year... Talk about bad timing...
Mylan CEO to testify before House panel over EpiPen pricing Reuters 6 hours ago Comments Like Reblog on Tumblr Share Tweet Email
WASHINGTON (Reuters) - Mylan NL Chief Executive Officer Heather Bresch will appear at a Sept. 21 congressional hearing over price increases for its EpiPen emergency allergy treatment, the U.S. House of Representatives Oversight Committee said in a statement on Wednesday.
Mylan has been widely criticized, including by U.S. Democratic presidential candidate Hillary Clinton, for sharply raising the price of EpiPens, which are carried by people with life-threatening allergies.
Mylan, which acquired the product in 2007, recently raised the list price for a pair of EpiPen auto-injectors to $600. The price has been rising from a cost of about $100 in 2008.
Mylan spokeswoman Nina Devlin confirmed that Bresch will attend the hearing.
"Heather is very good at being able to give an answer without offering much information," said Evercore ISI analyst Umer Raffat, adding that he will be watching for any other issues that might be raised by the Committee.
A probe into EpiPen pricing by a U.S. Senate subcommittee was announced on Sept. 7.
Bresch is the daughter of U.S. Senator Joe Manchin, a Democrat from West Virginia.
The House panel co-chairmen, Republican Representative Jason Chaffetz and Democratic Representative Elijah Cummings, noted there is “... justified outrage from families and schools across the country struggling to afford the high cost of EpiPens."
The committee planned to look at how to spur competition in the EpiPen market and speed approval by the Food and Drug Administration (FDA) of generic alternatives, according to the statement.
In response to the furor, Mylan last month said it would sell its own generic version of EpiPen for $300.
Teva Pharmaceutical Industries, which for years has been working on developing a generic alternative to EpiPen, said last week that it hopes to gain U.S. approval by late 2017 or early 20018.
EpiPen, which has annual sales of about $1 billion, delivers a potentially life-saving dose of epinephrine by injection into the thigh to counter dangerous allergic reactions, including to peanuts and bee stings. Mylan owns 94 percent of the market for such auto-injected devices.
The committee said it also planned to call as a witness Dr Doug Throckmorton, the FDA's deputy director at the Center for Drug Evaluation and Research.
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Post by mannmade on Sept 14, 2016 18:10:39 GMT -5
So with all the doom and gloom... And yes I agree, until resolved, money is a big issue as are scripts... But I do think they will get resolved.... and we will see progress on both by the end of the year. However, even with some dilution, again imo, the MannKind story is picking up a little bit of steam, slowly but surely... Let's review... 1. AFREZZA 2.0 well underway and we should see steady climb of scripts moving forward... 2. Epi is a potential big opportunity that they seem to have had a jump on. 3. RSL is out there with a milestone payment of some kind by end of year for an as yet unknown product partnership. 4. Mintaka seems to have a partnership with Mnkd for inhaled oxytocin. 5. Not to mention their pipeline (and I won't for purposes of this post as the products in the pipeline are further out from production) So to me it looks like they have four very real products/partnerships (an actual portfolio of drugs...) that could all be available next year. While AFREZZA may be the only one with blockbuster potential, the others will contribute to revenue and the image/press of MannKind and then be reflected in the share price imho... The sum of all parts... It is the beginning of the inhaled revolution... Clinton was ahead of his time... Only now he can inhale...
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Post by mannmade on Sept 14, 2016 14:36:01 GMT -5
No need for a reverse split if we have all this time, imo. Unless they want to reduce number of shares outstanding.
I would think the Mann Foundation will have a say in how that is handled along with any financing moving forward.
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Post by mannmade on Sept 14, 2016 13:59:33 GMT -5
So basically we have six months to get back above $1.00. Now that should be quite doable even with pending dilution. Scripts, scripts scripts...
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Post by mannmade on Sept 13, 2016 20:08:17 GMT -5
CC, I like your sense of humor...
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Post by mannmade on Sept 13, 2016 19:44:33 GMT -5
Cone snail venom could hold key to efficient therapies for diabetes Published on September 12, 2016 at 1:54 PM · No Comments
New research has found that venom extracted from a species of marine cone snail could hold the key to developing 'ultra-fast-acting' insulins, leading to more efficient therapies for diabetes management.
Researchers from Australia and the US have successfully determined the three-dimensional structure of a cone snail venom insulin, revealing how these highly efficient natural proteins called Con-Ins G1 can operate faster than human insulin.
The teams also discovered that Con-Ins G1 was able bind to human insulin receptors, signifying the potential for its translation into a human therapeutic.
Associate Professor Mike Lawrence from Melbourne's Walter and Eliza Hall Institute of Medical Research led a collaborative study between the University of Utah, the Monash Institute of Pharmaceutical Sciences, La Trobe University and Flinders University in Australia.
Associate Professor Lawrence, a specialist in the structure of insulins and their receptors, said the teams utilised the Australian Synchrotron to create and analyse the three-dimensional structure of this cone snail venom insulin protein with exciting results.
"We found that cone snail venom insulins work faster than human insulins by avoiding the structural changes that human insulins undergo in order to function -- they are essentially primed and ready to bind to their receptors, " Associate Professor Lawrence said.
Associate Professor Lawrence said human insulins could be considered 'clunky' by comparison.
"The structure of human insulins contain an extra 'hinge' component that has to open before any 'molecular handshake' or connection between insulin and receptor can take place.
Related Stories Stealth insulin-producing pig cells may offer solution for treating Type 1 diabetes in humans Study finds tight glycemic control provides no impact on patient-important microvascular outcomes Charity funding awarded to new study aiming to prevent kidney damage in patients with diabetes "By studying the three-dimensional structure of this snail venom insulin we've found how to dispense with this 'hinge' entirely, which may accelerate the cell signalling process and thus the speed with which the insulin takes effect." Associate Professor Lawrence said.
Published today in Nature Structural and Molecular Biology, the team's findings build on earlier studies from 2015, when the University of Utah reported that the marine cone snail Conus geographus used an insulin-based venom to trap its prey. Unsuspecting fish prey would swim into the invisible trap and immediately become immobilised in a state of hyperglycaemic shock induced by the venom.
Dr Helena Safavi-Hemami from the University of Utah said it was fascinating to uncover how the cone snail insulin was able to have such a rapid effect on its prey and, furthermore, that the peptide had therapeutic potential in humans. "We were thrilled to find that the principles of cone snail venom insulins could be applied to a human setting," Dr Safavi-Hemami said.
"Our Flinders University colleagues have shown that the cone snail insulin can 'switch on' human insulin cell signalling pathways, meaning the cone snail insulin is able to successfully bind to human receptors," Dr Safavi-Hemami said.
"The next step in our research, which is already underway, is to apply these findings to the design of new and better treatments for diabetes, giving patients access to faster-acting insulins," she said.
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Post by mannmade on Sept 13, 2016 16:44:32 GMT -5
Whatever happened to the Torrey Pines Partnership?
Two Californian research teams are on the path to ending the opioid crisis — and their drugs have one thing in common
pills Most pills today are made in factories like this one in Indonesia. Enny Nuraheni / Reuters Opioid painkillers are killing people. Lots of people.
Not only do they slow down breathing, they also act on the same brain systems as heroin. As such, prescription painkillers carry serious risks, from overdose to, in rarer cases, addiction.
So far, our pharmaceutical solutions have been focused on designing painkillers that are called "abuse deterrents." Their allegedly adult-proof packaging is supposed to make them hard to get high on, but there's little evidence to suggest that these drugs alone will be enough to end the opioid crisis.
Instead, the solution may lie in a slightly more complex task: Creating drugs that can't possibly get you high in the first place.
A handful of companies is working on formulations of drugs that are designed to relieve pain while simultaneously preventing the warm, snug, all-enveloping high that can be achieved when the pills we have now are taken in high enough doses. Several have already made it past some of the more preliminary hurdles of drug testing; others are still being studied in mice.
The drug that enters the brain too slowly to get you high In San Francisco, California, researchers employed by a company called Nektar Therapeutics are working to build a drug designed to enter the brain too slowly to cause a high.
"It’s a medicine that I’m very passionate about," Dr. Stephen K. Doberstein, the company's senior vice president and cheif scientific officer, told Business Insider during a recent phone call. "We have a chance to really positively impact medicine here."
The problem, as Doberstein sees it, is simple: "There's almost no new development of new opioid molecules. Everyone just wants to figure out how to lock it up in a pill better," he said.
Indeed since 2010, the US Food and Drug Administration has approved a handful of "abuse deterrent" drug formulations; 30 more are currently in development. In a March address to a panel of advisers, FDA commissioner Dr. Robert Califf focused on these drugs as one of the biggest solutions to curbing the overdose epidemic.
" ... The promise that we are on a path toward products that are effective in preventing abuse both by patients and non-patients is real. And the agency intends to fully support efforts to advance this technology," said Califf.
robert califf Food and Drug Administration Commissioner nominee Doctor Robert Califf (C) arrives to testify during his nomination hearing before the Senate Health, Education, Labor and Pensions Committee on Capitol Hill in Washington, November 17, 2015. REUTERS/Gary Cameron
Several people at the address warned that these pills might not be enough for several reasons, the Associated Press reported. First, overstating the benefits of abuse-resistant drugs could encourage doctors to continue overprescribing them. Second, we still don't know that the new pills will actually reduce overdoses or deaths. Most of them, the AP pointed out, can still be abused simply when swallowed.
"I am not convinced that we can engineer our way out of this epidemic, and I would caution against over-relying on abuse deterrent formulations to do so," Dr. Caleb Alexander, an associate professor of epidemiology at Johns Hopkins and the founding co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, told AP.
This is where Nektar's drug, so far called only NKTR-181, comes in.
"We have a chance here to actually separate analgesia [pain-relief] from euphoria [the drugs' characteristic 'high']. We should do that," said Doberstein.
Tests of NKTR-181 in recreational drug users have so far yielded promising results.
"We gave the drug to a set of patients and we asked them, 'How high do you feel right now? Would you pay money to have this experience again?' And what we found was that in most doses, the 181 was essentially indistinguishable to a placebo. They weren’t feeling anything with respect to getting high," said Doberstein.
"That was really a remarkable finding," said Doberstein. "I don’t think we’ve seen anything like that in the literature for these types of drugs before."
In tests of the same group of people designed to determine if the drug was working for temporary pain relief against a placebo or sugar pill, the drug performed well. Now, the company needs to show that the drug can work for chronic, severe pain. The company began Phase III tests of NKTR-181 in people with chronic low back pain in February of last year. Those results are expected this coming spring.
A drug that won't trigger a dopamine surge A brand new company called Epiodyne started by a research team at the University of San Francisco's School of Pharmacy is designing a drug that wouldn't trigger a surge in dopamine, a chemical messenger in the brain that is involved in emotions like desire and pleasure.
Across the US but primarily in Eastern states hit the hardest in recent months by the the opioid epidemic, many people are becoming addicted to painkillers because of the complex set of effects they can have on the brain in people who are predisposed to addiction. The results are often tragic.
"What we’re seeing here in New Hampshire is people get hooked on opioids and then they switch to heroin because it’s easier to get," Senator Jeanne Shaheen (D-New Hampshire) said on a call with reporters in June. "We're losing more than a person a day due to overdose deaths," she added.
drug overdose opioid epidemic Patty DiRenzo of New Jersey gives a kiss to her son, Salvatore Marchese, in 2012. DiRenzo's son died of a drug overdose in 2010. AP Photo/Brynn Anderson
The way opioids work to relieve pain is often described by experts as a double-edged sword. While they can reduce the burning sensation of an aching back or a stinging wound, they also act in the brain in ways that can affect complex emotions like desire and pleasure.
The reason we feel good when we eat a good meal or have sex, for example, can be chalked up to a series of naturally produced keys ("ligands") and keyholes ("receptors") that fit together to switch on our brain's natural reward system. Opioids mimic the natural keys in our brain. When they click in, we can feel an overwhelming sense of euphoria. More importantly, though, when prescription painkillers act on our brain's pleasure and reward centers, they can work to reinforce behavior, which in some people can trigger a repeated desire to use.
Epiodyne thinks it may have a drug candidate as powerful as morphine that could help avoid this problem. But it's still too early to say if the drug, known only as PZM21, might help people — so far it's only been tested in mice.
"What we know is that mice don't seem to like it, meaning they don't go back for more if given the choice. That gives us hope that it might not be addictive," Dr. Brian Shoichet, the chief scientist behind the drug who also runs the Shoichet Lab at the University of California San Francisco, told Business Insider.
He and his team have a steep hill to climb. Drugs like these tend to followed a pretty dismal pattern of development: They make it to animal testing, but never get past that stage to be tried in humans. At best, “the odds seem to be 1 in 10,” Pinar Karaca-Mandic, a health policy researcher at the University of Minnesota, recently told Reuters.
Still, one of the characteristics of PZM21 that could put it a step ahead of NKTR-181 — if its promising results are borne out in extended trials — is that it is fundamentally different from traditional opioids in two major ways: First, it doesn't appear to slow breathing like traditional opioids; and second, it only affects a type of pain called affective pain, which refers to chronic pain that's typically felt consistently, like the ache of a sore back. Conversely, it appears to have no impact on something called reflex pain, the type of pain that is recognized immediately, like the painful heat of your hand on a hot stove.
This could be a big benefit that the drug would have against other traditional painkillers, since it ideally wouldn't block people's ability to respond to a sudden shock of pain in their environment. "You don’t want someone doped up on pain relief medication and not being able to feel a hot stove," Shoichet pointed out.
Taken together, all of these observed effects suggest that PZM21 is fundamentally different from traditional opioids. And that's a big deal.
"That's completely unprecedented. That says this molecule is working in ways that no other molecule has," said Shoichet
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Post by mannmade on Sept 13, 2016 16:30:08 GMT -5
How an Android-powered artificial pancreas could revolutionise diabetes management An artificial pancreas -- a closed-loop system using monitors, pumps, algorithms, and an Android smartphone -- could be hitting the market in a matter of years.
Jo Best By Jo Best | September 13, 2016 -- 12:00 GMT (05:00 PDT) | Topic: Innovation
5 72 9 picture-cap-070616.jpg The components of the artificial pancreas, and the system in use.
Image: University of Cambridge You might not think an awful lot about your pancreas, because it's just getting on with its job of making sure your body has enough fuel to keep working. But if you're a diabetic, you'll be thinking about it a lot.
The pancreas is responsible for making and releasing insulin, an enzyme that helps control the level of glucose in the blood -- the substance all cells in your body use as their main source of energy. In type I diabetics, the pancreas isn't producing enough insulin. Without regular manual injections of insulin up to six times a day, diabetics' insulin levels will drop to dangerously low levels, with potentially fatal consequences.
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Read More Until now, type I diabetics have typically managed their condition by manually monitoring their blood glucose levels with simple probes, and then injecting themselves with insulin several times a day. More recently, glucose pumps have been helping to automate the process: the pumps deliver insulin when needed through a tiny tube, known as a cannula, under the skin. Diabetics still have to top themselves up with extra insulin after eating, though.
However, the way that type I diabetics keep on top of their condition could be about to change, thanks to technology. From as early as next year, medical hardware companies are expected to release devices known as "artificial pancreases": closed-loop systems that will automatically monitor the wearer's glucose level and top it up as and when needed -- courtesy of an algorithm stored on a simple Android phone.
A team researching artificial pancreas technology at the University of Cambridge has already produced a prototype of an artificial pancreas closed-loop system.
Not only does it free type I diabetics from the need to continuously track and adjust their own glucose levels, it can keep them within a much narrower range of glucose than they would be able to themselves.
While conventional glucose pump technology will stop delivering insulin when blood sugar hits a certain level or is predicted to do so, the Cambridge team's artificial pancreas prototype monitors glucose levels and suspends or increases insulin as and when needed.
"The basic idea [behind the pancreas] is to improve glucose control in people with type I diabetes, and the reason is, because it's not very good! It's not very good because our body does an amazing function of keeping glucose control very tight, by changing the amount of insulin and other hormones in the body every hour and every minute, and also day to day. That's really difficult to achieve in people with type I diabetes," Dr Roman Havorka, who leads the Cambridge University research, told ZDNet.
While diabetics might not be able to adjust their own insulin levels overnight, artificial pancreases can keep glucose levels within the desired range from hour to hour. Over the course of one night to the next, a person's insulin requirement can be anything from 30 percent of their average requirement to 300 percent of it. "This underlying variability makes conventional therapy difficult, and it's why people have episodes of low glucose," Havorka said.
While the components of the artificial pancreas have all been singly available for some time, no commercially available system has been able to link them all together.
The Cambridge prototype system, however, has. "We really tried to move quickly with available technology. There have been lot of big promises made and then reality kicks in," Havorka said. "Our idea, and the whole [artificial pancreas] movement is to reduce the existing components -- which is the continuous glucose monitor and to use the insulin pump and have a computer program which links the glucose measurement to insulin delivery," Havorka said. "It takes away the syncing process from people and does it behind the scenes."
The algorithm was built using the researchers' mathematical computer models of glucose metabolism, which are then individualised to reflect the particular diabetic patient that will wear the system, and how different doses of insulin will affect them. The optimal insulin levels are trialled in a simulation environment to test the various settings of the system.
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Read More While ultimately the aim would be to make a system that's far smaller than the existing prototype, for now, artificial pancreas researchers are keen for time to market to take precedence over form factor.
In the prototype, the Cambridge University-developed system uses an Android smartphone to run the homegrown insulin-syncing algorithm. "The mobile phone is the hub for the computer program and all the communication is wireless." For trials of the prototype, the phone is locked down, but it could ultimately be made available as a common-or-garden app.
By using the phone as the lynchpin of the system, the prototype can also give diabetics or their physicians an insight into their condition through the data it gathers. "People can always see what their glucose volume is and how much insulin is being given," Havorka said.
Of course, with any technology, there's a risk of failure -- the phone needing a reboot at a critical time, a sensor goes dark, a cannula gets blocked. If something goes wrong the system will set off an alarm to let the wearer know their glucose level has dropped too low. Researchers are currently working out the best way to use those alarms to alert patients of problems without causing "alarm fatigue", where users grow too accustomed to the warnings and begin to ignore them.
Before the artificial pancreas systems can be released, they'll need to undergo clinical studies to prove they're safe for use. The Cambridge group has already had diabetics use the system in their own homes without medical supervision, in groups including children, adults, and pregnant women.
"These are really free-living studies where people drive, do exercise, go on holiday, go to school. These studies are ongoing now, and we're planning longer studies" of up to one and three years, Havorka said.
The hope is that the technology won't just deliver physiological benefits either: it'll make the lives of diabetics and their families that bit easier too by taking the hassle out of managing the condition -- particularly important for young people and teenagers who can find adherence to treatment difficult. "The overall wellbeing of people improves, the stress in the family is reduced, and people should be living more normal lives," Havorka said.
The first closed-loop system is expected to be approved by the FDA next year, with commercials units released not too long after that.
"The FDA is really supportive of that technology reaching people with type I diabetes. The FDA approach is accelerated, they are saying people with type I diabetes have everyday risks of untoward occurrences and adverse glucose values, and the whole community is willing to accept these systems because traditionally if any treatment comes out, it needs to be shown to be bulletproof They're saying the community is willing to accept things that aren't bulletproof and we won't stand in the way. It's amazing."
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Post by mannmade on Sept 13, 2016 11:30:44 GMT -5
Google's Diabetes Partnerships Could Be Just The Start Sep. 13, 2016 12:23 PM ET|1 comment | About: Alphabet Inc. (GOOG), GOOGL, Includes: AAPL, ANTM, IBM, MDT, NVO, NVS, QCOM, SNY EP Vantage EP VantageFollow(2,255 followers) Newsletter provider, biotech, healthcare Send Message|EP Vantage Google’s (NASDAQ:GOOG) (NASDAQ:GOOGL) latest venture – the diabetes collaboration with Sanofi (NYSE:SNY) now known as Onduo – is another example of tech companies getting involved in the healthcare world. Google has been particularly active, with six pharma and medtech deals since 2014, but other players like IBM (NYSE:IBM) and Qualcomm (NASDAQ:QCOM) have also been busy (see tables below).
Diabetes is particularly ripe for disruption, as tech companies can exploit existing data from blood glucose monitoring to evaluate various interventions. Then there are the currently disparate components of therapy that could be brought together to improve care and cut costs. It is not beyond the realms of possibility that the likes of Google might eventually acquire a diabetes drug developer to combine glucose monitoring, analytics and therapy.
The cost argument is strong for this kind of approach. Drug prices are being squeezed by payers as governments face a surge in diabetes cases with aging and increasingly overweight populations, so anything that can make care more efficient is likely to have an edge.
If integrated strategies are also shown to reduce downstream costs from hospitalizations or disability due to diabetes-related complications, then so much the better. And the data processing power that technology groups bring could help to prove such a benefit. Meanwhile, the tech companies benefit from the regulatory expertise of the pharma groups.
It is therefore no surprise that five of the 16 technology crossover deals tracked by EP Vantage are in diabetes. Google, through its life sciences arm Verily, has a second collaboration in the space with Novartis’ (NYSE:NVS) Alcon division, which focuses on the other end of the care continuum, glucose monitoring using a novel device, a so-called smart contact lens. That deal also covers a smart lens to correct presbyopia, or age-related farsightedness.
Google’s ventures in pharma & medtech
Partner
Project
Date
Sanofi
Onduo: diabetes management
Aug 2016
GlaxoSmithKline
Galvani: bioelectronic medicines
Aug 2016
Johnson & Johnson
Verb: robotic surgery
Mar 2015
Biogen
Multiple sclerosis
Jan 2015
Abbvie
Calico: age-related diseases
Sep 2014
Novartis/Alcon
Smart lens technology
Jul 2014
Meanwhile, IBM and Qualcomm seem keen not to be left behind, with agreements with the likes of Medtronic (NYSE:MDT) and Novo Nordisk (NYSE:NVO) in diabetes.
The other sectors for collaborations are varied, but many are in other chronic disorders, as might be expected. Novartis, the most active pharma partner, also has several deals with Qualcomm, the most recent of which involves a smart inhaler for COPD.
As well as pharma groups, IBM has teamed up with the health insurer Anthem (NYSE:ANTM) and medical centers including the Mayo Clinic, among others.
IBM and Qualcomm’s deals with pharma & medtech
Company
Partner
Project
Date
Qualcomm
Philips
“Connected health”
Aug 2016
Qualcomm
Medtronic
Continuous glucose monitoring for diabetes
May 2016
Qualcomm
Novartis
Smart inhalers for COPD
Jan 2016
IBM Watson Health
Novo Nordisk
Diabetes management
Dec 2015
IBM Watson Health
Teva
Chronic conditions including asthma, pain, migraine and neurodegenerative diseases
Sep 2015
IBM Watson Health
Johnson & Johnson
Rehabilation after surgery
Apr 2015
IBM Watson Health
Medtronic
Diabetes management
Apr 2015
IBM Watson Health
Apple
Collection of personal health data
Apr 2015
Qualcomm
Novartis
“Trials of the future”/“Beyond the pill”
Jan 2015
Qualcomm
Roche
Chronic disease management
Jan 2015
One technology giant that has so far steered clear of big pharma deals is Apple (NASDAQ:AAPL) . However, Apple is still making moves in healthcare with its ResearchKit app, which is designed to gather data for use in medical research, and has signed up various academic institutions.
Interestingly, Apple and IBM have their own partnership, which combines Apple Watch sensors and the ResearchKit with IBM’s Watson Health Cloud – the first project for the two companies was a sleep health app.
A few years ago, eyebrows were raised when companies like Google made efforts to expand into healthcare, but now these kinds of deals are much more common. Similarly, an acquisition no longer seems so far-fetched.
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Post by mannmade on Sept 13, 2016 11:24:03 GMT -5
Now if only AFREZZA was approved in the UK...
Home Diabetes September 12, 2016 Study shows UK commercial pilots with insulin-treated diabetes can fly with no safety concerns September 12, 2016 A study presented at this year's European Association for the Study of Diabetes (EASD) meeting in Munich, Germany (12-16 September), shows that UK commercial airline pilots with insulin-treated diabetes can fly safely, with almost all of their blood sugar readings at safe levels. The study is by medical staff at Royal Surrey County Hospital, Guildford, Surrey, UK and the UK Civil Aviation Authority, Gatwick Airport, UK.
In 2012, the UK became the second country worldwide, after Canada, to issue insulin-treated individuals with Class 1 Medical Certificates for Commercial Pilot Licences (CPLs). The UK now has the largest cohort of insulin-treated pilots, and is leading the way in Europe and beyond to create and maintain employment and leisure opportunities for people with insulin-treated diabetes. A comprehensive protocol, developed by a panel of medical and aviation experts, governs the medical certification of insulin-treated pilots. Ireland joined the UK in April 2015 in applying an agreed Medical Assessment Protocol under the European Aviation Safety Agency (EASA) regulation. Certificated pilots are subject to strict requirements, directly overseen by the UK Civil Aviation Authority (CAA) and Irish Aviation Authority (IAA) medical departments, including pre- and in-flight blood glucose monitoring. This study aimed to evaluate the early experience and safety of the UK programme. With the pilots' consent, the files for all insulin-treated, Class 1-certificated pilots were reviewed and data were collected. This included: age; date of issue of Class 1 Medical Certificate; diabetes type and duration; diabetes management regimen; comorbidities; diabetes complication monitoring; all available HbA1c values (a measure of blood sugar control) pre- and post-licence issue; and all flights undertaken with associated blood glucose monitoring values. Average pre- and post-licence HbA1c values were compared. Pre and in-flight blood glucose monitoring values were correlated against the CAA-specified "Green" (5-15mmol/l), "Amber" (4-5 and 15-20mmol/l), and "Red" (<4 or >20mmol/l) ranges. The researchers found that at the analysis date, 26 insulin-treated pilots had been issued with Class 1 medical certificates. All were male, with an average age of 41 years. The majority (85%) had type 1 diabetes, with an average diabetes duration of 8 years. Average follow up duration post-licence issue was 19.5 months. The average pre-licence issue HbA1c was 53.1mmol/mol; the average of the most recent HbA1c was 54.8mmol/mol, thus showing no significant change.
A total of 8,897 blood glucose monitoring values had been recorded during 4,900 flight hours. For short and medium haul flights (under 6 hours), 96% of 7,829 blood glucose monitoring readings were within the 'green' range. For long haul flights (over 6 hours), 97% of 1,068 readings were within the 'green' range. A total of 19 (0.2%) readings across short and long haul flights combined were in the 'red' range and to date, no pilot medical incapacitation due to low or high blood sugar has been reported. Dr Hine says: "A growing number of insulin-treated pilots have successfully applied for Commercial Pilots' Licences in the UK and most recently Ireland. To date, the CAA protocol has shown to work well in the cockpit, with no reported safety concerns, and without deterioration of diabetes control." The study will be repeated, with these pilots and additional insulin-treated pilots who have gained Class 1 Medical certificates since the data were collected remaining under close follow up. Further data collection and analysis will follow. If commercial pilots are already licensed and develop diabetes after getting their licence, these pilots can apply for a Class 1 Medical certificate under the protocol described for insulin treated pilots. They must show that they have excellent control of their diabetes, with no significant complications and they must comply with the pre- and in- flight blood glucose monitoring protocol. Dr Hine adds: "The are a number of European states that have expressed interest in the programme. The American Diabetes Association's position is that individual assessment of people with diabetes is the appropriate approach to determining whether a person is qualified to perform certain activities. The Association is developing recommendations to share with the US Federal Aviation Administration (FAA) that would enable the FAA to identify pilots who are at no greater risk for incapacitation than any other pilot." (In the USA, diabetes diagnosis currently excludes pilots from flying commercial aircraft). The need for this careful protocol and monitoring is necessary, say the authors, since commercial pilots can work long shifts, with multiple short haul flight sectors, or a single long haul sector. This has the potential to disrupt normal eating patterns, particularly when crossing time zones. Insulin-treated pilots, however, must demonstrate excellent control and understanding of their diabetes in order to gain a Class 1 Medical Certificate. Dr Hine says: "Regular blood glucose testing in the cockpit ensures that any variability in blood sugar is detected and can be corrected early. If pilots are unable to test their blood sugar due to operational demands, the protocol dictates that they should consume 15mg of carbohydrate as a precautionary measure and then test within 30 minutes." In a separate presentation, Dr Stuart Mitchell, Head Authority Medical Section at the CAA, will give details of the safety protocol for these pilots, explaining how it was constructed.
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Post by mannmade on Sept 13, 2016 11:11:27 GMT -5
Home Diabetes September 13, 2016 New technique improves blood sugar control for people with diabetes September 13, 2016 A study by researchers at Karolinska Institutet conducted in collaboration with several other European research centres evaluates a device for measuring sugar levels in the subcutaneous fat of people with type 1 diabetes. The results, published in the journal The Lancet, show that the patients controlled their blood sugar much more often with the new, simpler technique and obtained safer glucose control.
The new technique involves the subcutaneous placement of a glucose sensor on the upper arm, enabling patients to easily take readings to monitor their current sugar control and see if the sugar level is stable, rising or falling. They can then preventatively make the necessary adjustments with more insulin or carbohydrates. "The idea is that the new technique will replace normal blood sugar tests," says principal investigator Jan Bolinder, professor of clinical diabetes research at Karolinska Institutet's Department of Medicine, Huddinge. The glucose sensor used in the study is called FreeStyle Libre and is already available on the market in Sweden and other European countries. However, this is the first publication where the technique has been evaluated in a randomised controlled study. Higher risk of hypoglycaemia The apparatus was tested on a group with well-controlled insulin-treated (via injection or pump) type 1 diabetes. Such patients run a higher risk of hypoglycaemia (low blood sugar), since the buffer zone between normal and low blood sugar is relatively narrow. A control group continued to use the conventional finger-prick means of checking their blood sugar. Masked sensor readings were also taken on this group for two consecutive weeks after intervals of three and six months to obtain comparative, detailed data on their sugar control over a 24-hour period. "The intervention group were able to use the device continuously for six months as often as they wanted, which immediately tripled the average daily frequency of self-testing" says Professor Bolinder. Increased the number of self-controls The patients randomly assigned to the Libre group immediately increased the number of self-controls from around five or six times a day to around 18. As a result of this, incidences of low blood sugar levels dropped by 38 to 65 per cent, accompanied by a reduction in the number of hypoglycaemic episodes by 33 to 55 per cent. There was also a shortening of the time spent with excessive blood sugar levels, while that spent with optimal sugar control increased. "We also used questionnaires on different aspects of life quality and satisfaction with the treatment, and here too we could see positive results," says Professor Bolinder. What do you hope will come of your results? "It's important to evaluate assistive technology that can make life easier for patients with diabetes and help them obtain better and more stable sugar control. I hope that our positive results will help give more patients access to this type of aid." Have any new issues arisen that you would like to investigate further? "Our study examined well-controlled patients. New research is needed to see if this self-help device can also improve sugar control for patients who don't attain our treatment targets."
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