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Post by #NoMoreNeedles on Jun 13, 2017 5:45:15 GMT -5
MannKind says it's also eyeing international markets such as Brazil, Canada, Mexico, UAE, Australia, and even China. They're also exploring filing possibilities in the European Union. Most of that will be done through partners internationally, though some may remain MannKind-led launches worldwide.
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Post by madog365 on Jun 15, 2017 10:37:26 GMT -5
UAE is the only country in the MENA region that adopted an effective fast track system for registration of innovator drugs: Fast Track Innovator, which allowed quick access of innovator drugs to UAE patients & patients from neighboring countries who seek treatment in the UAE. "While most countries take between two and four years to register new drugs, the UAE is able to do so within two or three months." "We have an accelerated system for drug registration and these are not just generic drugs, but innovative medicines that are approved by the food and drug administration in the United States or the European medicines agency," said Dr Al Amiri. "We allow fast access to medicines to the patients who need them." Drugs are called innovators when it is the first time a particular combination is used. Trulicity, a diabetes innovator medication, was approved in the UAE in November last year, making the country the second in the world to register the drug." www.thenational.ae/uae/health/uae-fast-tracking-new-drugs-in-bid-to-tackle-growing-health-issuescheck out drugs which have received this fast track approval on slide 12. Afrezza will be next  usuaebusiness.org/wp-content/uploads/2017/01/UAE-Healthcare-and-pharmacuetical-economic-and-innovation-capacity.pdf |
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Post by madog365 on Jun 15, 2017 10:59:19 GMT -5
If it's really 2-3 months, The registration could be completed any day now... and i bet there is a regional partner already lined up that will be announced as soon as the drug is approved and registered.
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Post by brotherm1 on Jul 25, 2017 22:45:35 GMT -5
MannKind says it's also eyeing international markets such as Brazil, Canada, Mexico, UAE, Australia, and even China. They're also exploring filing possibilities in the European Union. Most of that will be done through partners internationally, though some may remain MannKind-led launches worldwide. This was probably posted somewhere before though I'm unable to find where. Speaking of Europe and also Roche (Roche on another thread today), Roche just might be interested in Afrezza. Being headquartered in Europe where Abbott's non-invasive glucose monitoring is approved and being paid for - at least partially - by insurance, bodes well for Afrezza and possibly Roche. Abbott wins reimbursement for glucose monitoring device by Nick Paul Taylor | May 8, 2017: Abbott has secured reimbursement for its FreeStyle Libre glucose monitoring technology in France. The nod positions Abbott to grow sales of the noninvasive blood glucose monitoring device in a country that is already the second-biggest market for the technology globally. FreeStyle Libre came to market in Europe in 2014 but it has taken time for Abbott to get healthcare systems across the continent’s fragmented payor landscape to cover the device. The addition of France to the list of countries in which the wearable sensor-based glucose monitoring technology is covered means the device is now fully or partly reimbursed in 13 nations. Confirmation France will reimburse the technology comes 10 months after the country’s health technology assessment agency gave its opinion on the device. The assessment found the device offered enough added clinical value to justify reimbursement. That judgement was based the perceived diagnostic value of FreeStyle Libre and the public health benefits of better managing the complications associated with types 1 and 2 diabetes. French officials classed the device as likely to deliver moderate improvements over self-monitoring of blood glucose using a capillary meter alone. Abbott said the ruling was the first time France has ruled a glucose sensing technology offers moderate improvements, a status that sits in the middle of the five-rank, no improvement-to-major improvement range used by French officials to classify the added clinical value of medical devices. The agency said the Dexcom G4 Platinum continuous glucose monitor was a minor improvement over a capillary meter in 2015, putting it one rung below FreeStyle Libre on the French ranking system. Abbott is hoping to build on the ranking to establish FreeStyle Libre as the preferred glucose monitoring technology in a major diabetes market. French officials put the size of the target population for FreeStyle Libre in the region of 300,000 patients. With FreeStyle Libre currently used by that number of people globally, there is scope for the French reimbursement nod to make a difference to Abbott. www.fiercebiotech.com/medical-devices/abbott-wins-reimbursement-for-glucose-monitoring-device |
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Post by mnholdem on Jul 26, 2017 7:31:15 GMT -5
I believe that Brazil also has changed its approval process during the past few years to expedite certain applications.
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Post by brotherm1 on Jul 26, 2017 15:17:52 GMT -5
"FreeStyle Libre came to market in Europe in 2014 but it has taken time for Abbott to get healthcare systems across the continent’s fragmented payor landscape to cover the device. The addition of France to the list of countries in which the wearable sensor-based glucose monitoring technology is covered means the device is now fully or partly reimbursed in 13 nations."
This reminds me of another company with a great product that came to the market in 2014 also, and of which is taking time to get healthcare systems' payor coverage.
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Post by thall on Jul 26, 2017 17:44:15 GMT -5
"FreeStyle Libre came to market in Europe in 2014 but it has taken time for Abbott to get healthcare systems across the continent’s fragmented payor landscape to cover the device. The addition of France to the list of countries in which the wearable sensor-based glucose monitoring technology is covered means the device is now fully or partly reimbursed in 13 nations." This reminds me of another company with a great product that came to the market in 2014 also, and of which is taking time to get healthcare systems' payor coverage. I posted a link under articles to a story about Roche partnering to develop a closed loop artificial pancreas, and the glucose monitor is provided by this company:
eversensediabetes.com/?whichSite=usa
Approved in Europe while US approval is pending. Pretty interesting device:
"A new way to continuously monitor glucose levels around-the-clock, without the need for weekly sensor insertions or having to carry another receiving device"
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Post by cyn on Jul 27, 2017 11:18:48 GMT -5
Does anyone know whether MNKD has ever presented in the past or plans to present at the 2017 International Diabetes Foundation (IDF) Congress on 4-8 Dec 2017 "or" the 15th Symposium of the International Diabetes Epidemiology Group (IDEG), 8-10 Dec 2017 ... both symposiums to be held in Abu Dhabi, United Arab Emirates. Deadline to submit Abstracts for the IDEG was extended to 30 Aug 2017. What better way to get international exposure for minimal cost. JMHO
www.ideg-diabetes.org/ www.idf.org/
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Post by mnholdem on Jul 27, 2017 11:34:15 GMT -5
I forwarded that information to CEO Castagna some time ago, since the conference committees are looking for dynamic speakers. I think Mike has the skillset to impress conference attendees.
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Post by sportsrancho on Jul 27, 2017 11:39:14 GMT -5
Tweeted out:
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Post by cyn on Jul 28, 2017 11:44:30 GMT -5
Oodles of international opportunities for MNKD to educate and promote Afrezza as an "Advanced Technology and Treatment for Diabetes" ... www.diabetesexpo.com/middleeast/events-list/advanced-technologies-treatments-for-diabetesI think MNKD needs to take a more aggressive "educator" posture on the global front... right out front with the many other pro-active international "academia" conference speakers dedicated to fighting the growing global diabetic epidemic. Of course, an aggressive US commercial DTC marketing campaign is critical at this juncture; however, MNKD should also join forces with the global academia and maximize every possible educational venue to get the word out about Afrezza. Imo, if Afrezza is to ever be recognized as an advanced technology, paradigm-shifting treatment, it's name needs to be constantly circulating among the global educators, collaborators and government medical leaders, etc... which might also ease insurance coverage resistance and stimulate partnership interests. |
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Post by cyn on Jul 28, 2017 12:57:44 GMT -5
Just bypass the squishy, career self-serving Endos and go straight to the real heroes committed to helping diabetic patients! Here's another inexpensive opportunity to get the word out about Afrezza to front-line health care "educators" right here in the US.... International Conference on Diabetes and Diabetic Nursing Care, September 20-21, 2017 Charlotte, North Carolina, USA. Sure hope MNKD intends to participate. Theme: A Global Platform to Reunite and Raise Hands against Diabetes diabetes.conferenceseries.com/ |
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