Alerts

The FDA has declined to approve the Afrezza inhaled insulin device pending further data, device maker MannKind announced. The whistle-sized inhaler was designed to administer mealtime doses of powdered insulin in metered, single-use cartridges but ran into problems with the FDA over a redesign. More studies requested. FDA limits amount …

Kombiglyze XR now available: A new oral treatment for Type 2 diabetes is now available. Kombiglyze XR (saxagliptin and metformin hydrochloride 5/500, 5/1000, 2.5/1000)

The First Animal (Pig) to Human Transplant for Sale to Type 1 Patients. Russia has announced that it will be the first nation to approve transplanting animal cells into humans, or xenotransplantation. First tested in Russia in 2007 on 8 patients, each were given between 1 and 3 transplants of …

Secondhand smoke ups diabetes risk. A government study released last week reports that people who are exposed to secondhand smoke have a higher risk of developing diabetes. More information will be coming soon.

Weight Loss Drug Approved: The FDA advisory committee has voted 13-7 that the modest weight-loss benefits of an investigational combination of naltrexone and bupropion (Contrave) outweigh the drug’s blood pressure risk. The FDA will make an approval decision by Jan. 31. The agency does not have to follow the advice …

Merck to buy insulin developer SmartCells Inc. in a deal that may exceed $500 million if development and regulatory milestones are met. SmartCells is a private company developing a form of insulin that responds only in a specific glucose concentration range. If successful, the treatment may lower the risk of …

KOMBIGLYZE™ XR (Saxagliptin and Metformin HCl Extended-Release) tablets approved in the U.S. for the treatment of Type 2 diabetes mellitus in adults — the first and only once-a-day metformin extended-release (XR) plus DPP-4 inhibitor combination tablet. FDA Rejects Another New Diabetes Drug – Linjeta, a new rapid acting insulin. FDA …

FDA: Chelation Products: Unapproved Over-the-Counter Drugs — Consumer Warning. FDA advised consumers to avoid “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases. These products can cause serious harm, including dehydration, kidney failure, and death. All FDA-approved chelation products require a prescription because they can only be …

FDA to announce its decision on the first once a week GLP-1 compound, Bydureon(TM) this Friday, Oct 22, 2010.

BYDUREON’s likely FDA approval in two weeks on October 22, 2010. Abbott Pulls Meridia from Market: Abbott announced that it is voluntarily withdrawing the diet drug sibutramine (Meridia) from the U.S. market. The drug has been linked to an increased risk of stroke.