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Yet Another CGM Approval

OrSense Ltd. announced today that it received European CE Mark approval for its NBM-200G, a non-invasive continuous monitor of blood glucose for people with diabetes. OrSense becomes the fourth company to receive approval for a CGM, although the company did not disclose any plans on a possible submission of the device to the FDA. Currently there are only two CGM devices approved in the US, the Guardian from Medtronic (NYSE:MDT)...

Yet Another CGM Approval

OrSense Ltd. announced today that it received European CE Mark approval for its NBM-200G, a non-invasive continuous monitor of blood glucose for people with diabetes. OrSense becomes the fourth company to receive approval for a CGM, although the company did not disclose any plans on a possible submission of the device to the FDA. Currently there are only two CGM devices approved in the US, the Guardian from Medtronic (NYSE:MDT)...

Wake up call – Again

One would suspect that if someone is hit in the head with a baseball bat often enough that eventually they will get the point. This unfortunately not the case when it comes to diabetes education. Despite a growing body of evidence that diabetes education is one the most effective tools in helping patients control their diabetes, education continues to be treated as the ugly sister. Instead physicians and drug companies...

Wake up call – Again

One would suspect that if someone is hit in the head with a baseball bat often enough that eventually they will get the point. This unfortunately not the case when it comes to diabetes education. Despite a growing body of evidence that diabetes education is one the most effective tools in helping patients control their diabetes, education continues to be treated as the ugly sister. Instead physicians and drug companies...

What is Dr. Gottlieb Smoking?

In today’s Wall Street Journal Dr. Scott Gottlieb penned an opinion piece entitled “Uncle Sam, M.D”. While the piece contained some valid points on the role our government should and should not play in the drug approval process. Diabetic Investor found one paragraph particularly disturbing. “Now we’re focused on unearthing cases where prolonged use of some drugs may prompt small elevations in the risk and even common events, like...

What is Dr. Gottlieb Smoking?

In today’s Wall Street Journal Dr. Scott Gottlieb penned an opinion piece entitled “Uncle Sam, M.D”. While the piece contained some valid points on the role our government should and should not play in the drug approval process. Diabetic Investor found one paragraph particularly disturbing. “Now we’re focused on unearthing cases where prolonged use of some drugs may prompt small elevations in the risk and even common events, like...

Is Acomplia the first Avandia causality?

Yesterday by a unanimous vote an FDA panel rejected Sanofi-Aventis (NYSE:SNY) diet/diabetes drug Acomplia. It’s difficult to asses what role, if any, the controversy over Avandia played in the panel’s decision as there were several concerns with Acomplia. While this news is a blow to Sanofi, Amylin (NASDAQ:AMLN) shareholders are likely to gain from the news. With Avandia prescriptions in a free fall, physicians are exploring alternative treatments options...

GSK is the worst over?

Many appear to believe that the worst is over for GlaxcoSmithKline (NYSE:GSK) and now may be the time to step back in and buy the stock. With the stock down nearly 12% since the news broke on Avandia its understandable why some believe this is a buying opportunity. Before putting your hard earned money on the line it may be wise to step back and look at how Merck’s (NYSE:MRK)...

Avandia – More Questions than Answers / Januvia safety questioned/Finally some good news for Abbott

The markets haven’t opened yet and already it’s been a busy day in the diabetes world. Leading the way today is the Congressional hearing on Avandia (you can watch the hearing at www.oversight.house.gov the hearing is set to begin at 10am EST). Prior to today’s hearings the New England Journal of Medicine released three editorials and one article on Avandia. This collection of information unfortunately creates more questions than answers...

The Avandia Hearing

This morning the House Committee on Oversight and Reform held hearings on the Avandia controversy and the FDA’s role in the process. Listening to the hearing and line of questioning by the members Diabetic Investor is reminded of something Abraham Lincoln said in a speech before the Illinois legislature in 1837 – “Politicians (are) a set of men who have interests aside from the interests of the people, and who,...