| Mannkind's Afrezza Seems Short of Breath Joseph Krueger submits: It seems I have been hearing a lot lately about Mannkind's (NASDAQ:MNKD) Afrezza, an inhaled form of rapid acting insulin. Afrezza completed phase 3 trials in 2009 and submitted an NDA for Afrezza to the FDA in May 2009. All was going well for MNKD and its stockholders until this March when the the FDA requested more information before agreeing to approve its experimental inhaled insulin device. The FDA asked for more information on data from the phase 3 clinical trial for Afrezza, as well as information about the insulin delivery device. The FDA expressed a need for more information to support the clinical utility of Afrezza and which patient population group Afrezza would be indicated for. In addition, the FDA also asked for a safety update, but did not ask for additional clinical trials or cite safety concerns. New fears and concerns over what seemed to be (in investors mind) a sure approval caused a 30% drop in stock price, which has yet to recover. Investors have plenty of reason to be skittish about Afrezza, as companies attempting to market inhaled insulin products have had some serious bumps in the road. Several years ago, many companies were seeking to bring an inhaled formulation of insulin to market as an alternative to injected insulin. Pfizer's (PFE) Exubera was the first to gain marketing approval in September 2006, but as early as October 2007 Pfizer pulled Exubera from the market due to low sales, losing $2.8 billion in development costs. Other drug makers including Eli Lilly & Co. (LLY) and Novo Nordisk A/S (NVO) were quick to follow Pfizer's lead, and halted development of their inhaled insulin products.Complete Story » seekingalpha.com |
Roche Diabetes Drug Faces Delay Roche said new safety concerns about its diabetes drug taspoglutide require deeper monitoring of patients' response to the medicine, which will push back an expected regulatory filing. online.wsj.com |
Vivus Gets Shot Down by the FDA Zacks.com submits: Vivus Inc. (VVUS) suffered a major setback recently when the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-6 against the approval of Vivus’ weight loss, once-daily pill Qnexa.The FDA panel’s vote was based on one-year data on Qnexa. The panelists said that they would prefer data from a longer period of study in order to pass a favorable judgment on the drug. Data from a two-year study of Qnexa are expected to be released in the second half of 2010.Complete Story » seekingalpha.com |
Enzo Biochem to Present at Two Healthcare Conferences in New York City [Business Wire] - NEW YORK----Enzo Biochem, Inc. , a leading biotechnology company specializing in gene identification and genetic and immune regulation technologies for diagnostic and therapeutic applications, announced today that Barry Weiner, President, and David Goldberg, Vice President, Corporate Development, will both be presenting at two upcoming institutional investor conferences: us.rd.yahoo.com |
Tengion Presents New Data Demonstrating Functional Regeneration in a Diabetic Chronic Kidney Failure Model at the International Society for Cellular Therapy [PR Newswire] - Tengion, Inc. presented new research data yesterday in a podium presentation at the 2nd Annual Symposium on Stem Cell Translation of the International Society for Cellular Therapy in San Francisco. Â The presentation highlighted new results from Tengion's Neo-Kidney Augmentâ„¢ development program demonstrating success with an autologous cellular therapy approach to kidney regeneration in a rodent model of obesity, diabetes and hypertension. Â us.rd.yahoo.com |