By Pharma Intelligence:On Nov. 14, the European Medicine agency granted approval for AstraZeneca (AZN) and Bristol-Myers's (BMY) novel drug Forxiga (dapagliflozin) for the treatment of type 2 diabetes. Forxiga acts through a novel mechanism to control blood sugar levels in type 2 diabetes patients.
The Burrill Report submits: The U.S. Food and Drug Administration informed Biodel (BIOD) that it would not approve in its present form its application for Linjeta (recombinant human insulin) injection for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control. Biodel said it plans to contact the FDA within the coming weeks to request a meeting to discuss the company's next steps and requirements for approval of Linjeta.
By Peter Geschek:
The FDA has just approved Johnson & Johnson's (JNJ) Invokana (previously known as canagliflozin), a once-a-day pill to improve glycemic (blood sugar) control in adults with type 2 diabetes.
The Burrill Report submits: Pfizer (PFE) and Medivation (MDVN) said dimebon, their experimental drug to treat Alzheimer’s disease, failed in two late-stage clinical trials. Medivation’s stock, which had been trading at an all time high of $40.49 right before the news, tumbled nearly 70 percent to $13.04. In one trial, dimebon did not show statistical significance compared to placebo in measures of cognition and global function – the primary endpoints for the study.
A new treatment option will soon be available to people with type 2 diabetes with the FDA's approval on Friday of Invokana, a first-in-class medication to lower blood sugar. Johnson & Johnson's Invokana (generic name canagliflozin) attacks blood sugar right from the get go, reducing the amount of sugar absorbed from food into the bloodstream. The body then flushes the excess sugar out in the urine.