The FDA accepts Eli Lilly's NDA for empagliflozin plus immediate-release metformin hydrochloride for the treatment of adults with type 2 diabetes (T2D). The product is part of the Lilly/Boehringer Ingelheim Diabetes alliance portfolio.
Empagliflozin is a sodium glucose co-transporter-2 inhibitor which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilize glucose.
The FDA approved Jardiance (empagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with T2D in August 2014. Metformin has been in clinical use for many years.
Diagnostics maker Alere (ALR +12.9%) bucks biotech's down day by jumping on a 6x surge in volume on reports that former CEO Ron Zwanziger intends to bid $46 per share for the company. His potential offer would value Alere at almost $4B.
Mr. Zwanziger believes the firm is undervalued. He has a point. Alere's sales and earnings are decelerating and its P/S, P/B and P/CF ratios all lag the industry according to msn money.
Alere (ALR +3.8%) CEO Ron Zwanziger, SVP R&D Jerry McAleer and CSO Dave Scott resign effective immediately. COO Namal Nawana will be interim CEO until a permanent chief is hired. The reasons for the mass exodus are not disclosed.
Via its 510k process, the FDA approves Alere's (ALR +1.9%) i Influenza A&B diagnostic test, the only molecular test that can detect and differentiate the influenza A and B virus in less than 15 minutes. The product was launched in Europe earlier this year.
The firm has rapid molecular tests in development for Strep A, C. difficile, RSV and chlamyida/gonorrhea.
Alere Inc enables individuals to take charge of improving their health and quality of life at home. The Company operates in three segments; professional diagnostics, health information solutions and consumer diagnostics.