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Bye Bye Galvus

In what could be the final blow to Galvus from Novartis (NYSE:NVS) the FDA has requested further studies to show Galvus safety and efficacy in patients with kidney impairment. As Diabetic Investor has been reporting all along this most recent delay has nothing to do with skin lesions. Just how long it will take Novartis to complete the requested studies is anyone’s guess although most believe that should Novartis proceed...

Medtronic Reports, More Problems for Avandia and other items of note

Yesterday Medtronic (NYSE:MDT) reported third quarter results with an impressive results for their diabetes unit were sales grew by 24%. This growth is particularly noteworthy as many had expected Roche’s reentry into the US pump market to adversely impact sales. Diabetic Investor never quite understood why people were worried about Roche’s return to the US market as their Spirit pump offers no major advantages over the many pumps already on...

Will Galvus be DOA?

While Novartis (NYSE:NOV) anxiously awaits the FDA’s decision on Galvus, Merck (NYSE:MRK) continues to aggressively push their DPPIV Januvia. Yesterday Merck announced they had filed two supplemental New Drug Applications for Januvia and expects a decision by mid-October. The problem for Novartis even if Galvus receives approval, which some expect in the very near future, will the successful launch of Januvia stymie Novartis efforts with physicians? Novartis sales reps...

Will Galvus be DOA?

While Novartis (NYSE:NOV) anxiously awaits the FDA’s decision on Galvus, Merck (NYSE:MRK) continues to aggressively push their DPPIV Januvia. Yesterday Merck announced they had filed two supplemental New Drug Applications for Januvia and expects a decision by mid-October. The problem for Novartis even if Galvus receives approval, which some expect in the very near future, will the successful launch of Januvia stymie Novartis efforts with physicians? Novartis sales reps...

Insulet Files S1- What it means for the insulin pump market

Insulet, the company that makes the OmniPod Insulin Management System has filed an S-1 with the Securities and Exchange Commission (SEC). (The S-1 can be found on the SEC’s web site www.sec.gov) According to the filing the company is looking to raise nearly $90 million in capital. Over the past few years Diabetic Investor’s views on the insulin pump market are well known. We continue to believe that the market...

CGM Update – What happens when the razors last longer thananticipated

One of the best things about the blood glucose monitoring business is that it follows the classic razor/razor blade business model. Patients are given the meter for free while companies make their money on the continual sale of test strips. Since test strips can be used only once there is no chance for the consumer to extend the life of the test strip. Even better for the companies in the...

CGM Update – What happens when the razors last longer thananticipated

One of the best things about the blood glucose monitoring business is that it follows the classic razor/razor blade business model. Patients are given the meter for free while companies make their money on the continual sale of test strips. Since test strips can be used only once there is no chance for the consumer to extend the life of the test strip. Even better for the companies in the...

Acomplia set back

Yesterday Sanofi-Aventis (NYSE:SNY) announced that the Food and Drug Administration (FDA) would not rule on Acomplia, the company’s obesity drug, until July 27th. Prior to this announcement company officials had publicly stated they were confident that Acomplia would gain FDA approval and be on the market in the second half of 2007. While the company did not provide an explanation for the delay, a decision had been expected sometime this...

Januvia and Byetta – Why they can co-exist and both prosper

Even before Januvia, Merck’s (NYSE: MRK) DPPIV, came to market many on the Street believed the drug would adversely impact sales of Byetta from Amylin (NASDAQ:AMLN). The general consensus was since both drugs were targeted at poorly controlled type 2 patients, primary care physicians who treat over 80% of patients with diabetes, would choose Januvia which is taken orally over Byetta which is injected. A great deal was made...

Roche and PolyMedica Report – What the results mean for the bloodglucose monitoring market

This morning Roche reported results for 2006 and as expected their blood glucose monitoring business, once a star business unit, has fallen on hard times. For the full year 2006 diabetes care sales grew just 3% from 2005. These results are hardly surprising as the entire blood glucose monitoring segment, with the notable exception of LifeScan, has seen growth dwindle over the past few years. Like others in this...