Alerts

FDA Finalizes Menu, Vending Machine Calorie Labeling Rules  The FDA has finalized two rules that require chain restaurants, retail food establishments and vending machines with 20 or more locations to list calorie information on a menu or menu board. Gabapentin Capsules USP 300 mg Recall  Aurobindo Pharma USA is voluntarily …

French Company Granted Rights to Implantable Pump Sevier, a pharmaceutical company based in France, agreed to make payments totaling over $1B to privately held Intarcia Therapeutics, Inc. for the rights to co-develop the company’s implantable pump, designed to deliver one year’s worth of the GLP-1 exenatide.

  Novo Nordisk has launched the NovoRapid PumpCart, the first prefilled pump cartridge with an insulin analog that has been specifically designed for insulin pumps. The new treatment solution contains NovoRapid (insulin aspart) — a rapid-acting insulin. The 1.6 ml cartridge was developed in a non-exclusive partnership between Roche Diabetes Care …

Trulicity Once-Weekly GLP-1 Shipping Now  Eli Lilly and Company announced that Trulicity, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) with once-weekly dosing in the Trulicity pen, was approved by the FDA on September 18, 2014, and is shipping to distributors now.

After two years, only 19 of original 32 CMS Pioneer ACO’s still participating. See this week’s Tool for Your Practice and Letter from the Editor.

Medicare Cracks Down on Hospitals with High 30 Day Readmission Rates A total of 2,610 hospitals in the U.S. will see their Medicare payments docked in fiscal 2015 for having excessive numbers of patients return to the hospital within 30 days of discharge. Some of the hospitals will lose 3% of their income …

FDA Approves New Once-Weekly GLP-1  See this week’s Item #1.

FDA Approves Once-Weekly Dulaglutide for Type 2 Diabetes Once-weekly dulaglutide was approved based on six clinical trials involving a total of 3,342 patients who received the drug. It was studied as a stand-alone therapy and in combination with metformin, sulfonylurea, thiazolidinedione, and prandial insulin. 

FDA Approves Weight Loss Drug Contrave. See this week’s Item #4. FDA Advisory Panel Recommends Approval of Novo Nordisk’s liraglutide (used now as Victoza to treat type 2 diabetes ) for use in chronically obese patients with at least one weight-related health issue. More news to come. The new drug would be …

Diabetes Drug Empagliflozin (Jardiance) SGLT-2 Inhibitor Available in Pharmacies See this week’s Item #10.