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FDA Archives

FDA

Page 3
FDA Approves Dexcom’s G4

The FDA has approved U.S. sales of Dexcom's G4TM PLATINUM continuous glucose monitor. The San Diego-based manufacturer said it is taking orders and plans to begin shipping the device to patients within the next few weeks.

Comments 2 comments - Nov 16, 2012 - * * * * *

Lilly Says Its New Injectible Outperforms 3 Popular Diabetes Drugs

Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.

Comments 0 comments - Nov 5, 2012 - * * * * *

Oral Agents for Lowering Blood Sugar in Type 2 Diabetes

Author’s note: Throughout this series, I will inject my own opinion, which frequently differs from that of the medical establishment in this field. Having had diabetes for more than 66 years, I place my emphasis on the well-being of fellow patients.

Comments 0 comments - Oct 21, 2012 - * * * * *

Needle-Free CGM Could Be Available in 2013

Philadelphia-based Echo Therapeutics plans to introduce a needle-free continuous glucose monitoring system to the US market in 2013, pending FDA approval. The Symphony® tCGM is a two-part device that monitors blood glucose by taking readings through a user’s skin rather than via finger pricks. It is intended for use by anyone with diabetes, not just insulin pump users.

Comments 1 comment - Sep 26, 2012 - * * * * *

US Sale of Generic Actos Gets FDA Nod

The Food and Drug Administration has approved US sale of generic pioglitazone (trade name Actos) for the treatment of type 2 diabetes. Actos, originally developed and trademarked by Takeda Pharmaceuticals, works by decreasing insulin resistance in type 2 patients. The prescription drug, which belongs to the class of drugs known as thiazolidinediones (TZDs), has enjoyed great commercial success in the United States since its introduction in 1999, posting estimated sales last year of $2.7 billion.

Comments 0 comments - Aug 27, 2012 - * * * * *

Social Media, Partnerships Are Top Topics at AADE12

As diabetes climbs to epidemic levels in the United States, and finding adequate resources to fund future U.S. healthcare remains in question, the need for an already existing "boots on the ground" group that can address the disease is greater than ever.

Comments 0 comments - Aug 15, 2012 - * * * * *

Type 1: New Drug Class Could Lead to Neuropathy Relief

University of California researchers report that they have found a new class of drugs that could lead to a pain relief treatment for people who have diabetic neuropathy. The drugs, which were successfully tested on lab animals, are anti-inflammatory compounds that inhibit the action of an enzyme called soluble epoxide hydrolase. The enzyme is key to the transmission of pain sensations. Previous research has shown that inhibiting soluble epoxide hydrolase also lowers blood pressure and protects against kidney damage.

Comments 0 comments - Jul 7, 2012 - * * * * *

ADA Sessions Spotlight Powerful Weapons Against Diabetes

Several hopeful trends emerged from this year's ADA Scientific Sessions in Philadelphia, held June 8 through 12.

Comments 0 comments - Jun 23, 2012 - * * * * *

When Medical Devices Fail

Medical devices aren't just any old pieces of technology. Lives depend upon them. For that reason, the government outlined a process decades ago by which manufacturers and importers were supposed to report malfunctions. But there was one problem: When malfunctions occurred, the manufacturers and importers did not admit it. According to the Food and Drug Administration, "A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported."

Comments 0 comments - Jun 22, 2012 - * * * * *

Dexcom Proudly Sponsors Historic Diabetes Flight Formation Trip To Raise Juvenile Diabetes Research Foundation Funds Dexcom Proudly Sponsors Historic Diabetes Flight Formation Trip To Raise Juvenile Diabetes Research Foundation Funds

SAN DIEGO - June 15, 2012 - Dexcom, the leader in continuous glucose monitoring, is proudly sponsoring the efforts of the Diabetes Formation Flight USA(DFFUSA.org) - three pilots with insulin-dependent diabetes using Dexcom's Seven Plus as part of their effort to set new transcontinental world speed records while raising funds for the Juvenile Diabetes Research Foundation (JDRF).

Comments 0 comments - Jun 20, 2012 - * * * * *

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