Newsflash

FDA Panel Gives Nod to New Diet Drug

FDA Panel Gives Nod to New Diet Drug An FDA advisory committee has voted 18-4, with one abstention, in favor of approving lorcaserin hydrochloride (Lorqess). It would be the first new weight loss drug in more than a...

Fast-Acting Erectile Dysfunction Drug Stendra (TM) (avanafil) Approved

Fast-Acting Erectile Dysfunction Drug Stendra (TM) (avanafil) Approved

ADA/EASD Issue New Management Guidelines and FDA Rejects Diabetes Drug Alogliptin

ADA/EASD Issue New Management Guidelines (see this week's Item #2) and FDA Rejects Diabetes Drug Alogliptin (

FDA pushes back decision on weight loss drug Qnexa to July 17.

FDA pushes back decision on weight loss drug Qnexa to July 17. 

FDA Okays Levemir for Pregnant Women

FDA Okays Levemir for Pregnant Women  The FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to...

Johnson & Johnson to possibly sell their Animas Diabetes Pump and One Touch Glucose Monitor divisions.

Johnson & Johnson to possibly sell their Animas Diabetes Pump and One Touch Glucose Monitor divisions.  

Amylin rejects Bristol-Myers Squibb’s 3.5 billion purchase offer.

Amylin rejects Bristol-Myers Squibb’s 3.5 billion purchase offer.

FDA Looking at Making Diabetes Drugs Available Over the Counter

FDA Looking at Making Diabetes Drugs Available Over the Counter See this week's Item #3, Diabetes and Statin Meds to Be Available without a...

Artificial Pancreas Works

Artificial Pancreas Works For three days a 12 year old girl with Type 1 diabetes wore a CGMS and a special pump with insulin and glucagon. She ate whatever she wanted and the device worked perfectly, adjusting her insulin and...

FDA Adds Diabetes Warning to Statin Label

FDA Adds Diabetes Warning to Statin Label The FDA is changing the labeling on statins to include a warning about increased risks of hyperglycemia and transient memory problems, but the agency is no longer recommending routine liver...

FDA Panel Votes in Favor of Weight Loss Drug Qnexa

FDA Panel Votes in Favor of Weight Loss Drug Qnexa An FDA advisory panel has voted 20-2 to recommend approval of the weight-loss drug Qnexa, but urged the agency to require a post-approval trial to monitor for cardiovascular side...

Bydureon and Medicare Updates

Bydureon is now available in pharmacies. Medicare Update: The 28% cut in physician payments scheduled to begin March 1 will be postponed and/or will be offset by cuts in the budget.

FDA Approves Third New Diabetes Drug within Last 7 Days

FDA Approves Third New Diabetes Drug within Last 7 Days See this week's Item #3 for information on the third new drug approved by the FDA...

FDA Approves Second New Diabetes Drug within Three Days

FDA Approves Second New Diabetes Drug within Three Days Bydureon was the first to be approved, now find out what the second new drug is. (See...

Bydureon Approved for Sale in the US

Bydureon Approved for Sale in the US FDA approves Bydureon as adjunct treatment of type 2 diabetes. In a letter posted to the Food and Drug Administration website, the FDA said that Bydureon was approved as an adjunct to diet and...

FDA Issues Response Letter on Dapagliflozin

FDA Issues Response Letter on Dapagliflozin The FDA has issued a complete response letter regarding the New Drug Application for investigational compound dapagliflozin (SGLT2) for the treatment of type 2 diabetes in adults. The...

Warning Letter Issued by FDA to J&J for Delayed Reporting for Insulin Pump Problems

Warning Letter Issued by FDA to J&J for Delayed Reporting for Insulin Pump Problems See this week's Item #11.

Medtronic Remote Diabetes Monitor Gets U.S. Approval

Medtronic Remote Diabetes Monitor Gets U.S. Approval See the Product of the Week and

CDC: Hep B Vaccine Needed for Diabetic Adults

CDC: Hep B Vaccine Needed for Diabetic Adults See this week's Item #4.

Antibodies Holds Keys to Diabetes Breakthrough

Antibodies Holds Keys to Diabetes Breakthrough See this week's Item #3.

FDA Restricts Lap-Band Claims

FDA Restricts Lap-Band Claims "I lost 90 pounds with the Lap-Band" should also include that it has Serious Risks. FDA has warned eight surgical centers and a marketing firm in California about misleading advertising of the Lap-Band.

FDA Approves Sanofi's iBGStar iPhone Glucose Monitor

FDA Approves Sanofi's iBGStar iPhone Glucose Monitor See Product of the Week below.

Medicare Pays for Intensive Obesity Counseling

Medicare Pays for Intensive Obesity Counseling See this week's Item #1, Medicare Now Pays for Intensive Obesity...

Sitagliptin/Pioglitazone Combo Application Withdrawn in EU

Sitagliptin/Pioglitazone Combo Application Withdrawn in EU Merck Sharp & Dohme Inc. has withdrawn its marketing authorization application for sitagliptin/pioglitazone (Janacti).

Lilly and Amylin Agree to End Partnership

Lilly and Amylin Agree to End Partnership See this week's Item #3, Lilly and Amylin Agree to End Diabetes Alliance.

New First in Class SGLT2 Drugs Hit a Stumbling Block

New First in Class SGLT2 Drugs Hit a Stumbling Block FDA delays verdict on Astra/Bristol SGLT2 diabetes pill until Jan 28th, the same day they are deciding on the possible approval of Bydureon.

FDA Approves New Use for BYETTA® (exenatide)

FDA Approves New Use for BYETTA® (exenatide) BYETTA is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type ...

Shortage of Apidra®

Shortage of Apidra® There will be a temporary supply shortage of Apidra® SoloSTAR® pens in the US starting in late Oct. Due to the possible shortage, from now until April 30, 2012, Apidra vials will have NO...

FDA Approves Diabetes and Cholesterol-Lowering Drug Combo

Bydureon Kit (Not Yet Approved in the US) See this week's Item #3, FDA Approves Diabetes and Cholesterol-Lowering Drug Combo:...

Novo Files for Degludec and DegludecPlus Approval in Europe

Novo Nordisk has filed for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in Europe. According to their press release Novo will also be submitting both drugs to the FDA within two weeks. Both drugs will be available...

The Best from the 47th Annual Meeting of the European Association for the Study of Diabetes, Lisbon, Portugal.

The Best from the 47th Annual Meeting of the European Association for the Study of Diabetes, Lisbon, Portugal. See all of our coverage on the 47th EASD from the

Linagliptin, FreeStyle Navigator CGMS System, and EpiPen

Linagliptin has received approval in Europe for the treatment of type 2 diabetes. Abbott is permanently discontinuing the FreeStyle Navigator CGMS System in the U.S. Supplies will continue to be available until March...

Bayer is recalling Contour® and Contour® TS test strips in the US

Bayer is recalling Contour® and Contour® TS test strips in the US According to Bayer this recall applies to 10 and 25 count test strip vials for the Contour® and 10 count test strip vials for the Contour® TS. The company also noted the...

Tylenol Maker Lowers Maximum Dose

Tylenol Maker Lowers Maximum Dose McNeil Consumer Healthcare announced it is lowering the maximum daily dose instructions for Extra Strength Tylenol to six pills a day (3,000 mg) to reduce the risk of acetaminophen...

Bydureon Coming Soon

Bydureon Coming Soon See this week's Item #1, Lilly Resubmits Bydureon to FDA, for more information.

Dapagliflozin rejected by FDA

Dapagliflozin rejected by FDA, but AstraZeneca's new antiplatelet agent, Brilinta (ticagrelor), is approved.

Artificial Pancreas Closer to Reality

Artificial Pancreas Closer to Reality See this week's Item #1, ADA: Scientists Getting Closer to Artificial Pancreas.

BYDUREON™ Receives Marketing Authorization in Europe

BYDUREON™ Receives Marketing Authorization in Europe BYDUREON showed statistically significant improvements in glycemic control based on reduction of A1C (a measure of average blood sugar over three months) between 1.5...

FDA Reminder Warning on Liraglutide

FDA Reminder Warning on Liraglutide FDA warns healthcare professionals to closely monitor patients with diabetes receiving liraglutide injections.

Germany & France suspend the use of Actos, Label Change for Zocor

  Germany & France suspend the use of Actos, a TZD diabetes drug, due to worries about a possible link to bladder cancer. Interim results from trials in the U.S. one of which began in 2003 and is slated to last 10 years, have so far ...