By Bill Berkrot(Reuters) - An experimental once-weekly medicine for type 2 diabetes developed by Eli Lilly and Co proved as effective in lowering blood sugar as Victoza from Danish drugmaker Novo Nordisk in an eagerly anticipated late stage study.The Lilly drug, dulaglutide, achieved the primary goal of the 599-patient study by demonstrating so-called non-inferiority to the highest approved dose of Victoza after 26 weeks, according to initial results released by the company on Tuesday.
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.
BySharon di Stefano:Clinical interest in oral insulin, estimated to have market potential upwards of $10 billion, is escalating as more diabetics are diagnosed each year and patients' petulant demands for an alternative to needles and pens use up more of a doctor's limited practice time.
As the flu rages through our population, many people will run to their doctors hoping for the miracle of modern medicine. When doctors see a patient with symptoms of the flu they often prescribe a drug known as Tamiflu, known generically as Oseltamivir. Tamiflu is a nuraminidase inhibitor, which means it blocks the actions of a protein that is essential for the flu virus to make copies of itself.
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.
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.
By Ry Frank:GlaxoSmithKline (GSK) will present its new diabetes drug Albiglutide at the annual meeting of American Diabetes next month. It will present its data from 8 late stage studies known as Harmony 6 and 7.