| China Nuokang Bio-Pharmaceutical Inc. Reports First Quarter 2010 Financial Results (GlobeNewswire) 1Q10 Revenue up 16.8% to RMB69.7 Million YOY us.rd.yahoo.com |
Spectranetics Corp Q2 2010 Earnings Call Transcript Spectranetics Corp (SPNC)Q2 2010 Earnings CallJuly 28, 2010 11:00 am ETComplete Story » seekingalpha.com |
Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug Sheff Station submits:October has been called the Super Bowl or World Cup of biotech approvals in the investing world. Whatever you want to call it, investors will be watching closely as many companies will have their drugs reviewed by the FDA for approval. This is often-times a turning point in a small biotech company's history in regards to whether or not they get approved or denied. In a previous article I focused on the recent financing and how that will fuel the future growth of Alexza Pharmaceuticals (ALXA). This piece will focus on key findings from a recent conference call that makes a strong case for the growth of Alexa heading into their Oct 11th PDUFA date for AZ-004 (Staccato Loxapine).There are often many questions that can come up prior to an approval date regarding efficacy or safety. These questions are most often addressed by an Advisory Panel of the FDA. An advisory panel is becoming more common for companies as these are often required before they await approval from the FDA. The advisory panel usually addresses potential issues regarding safety or efficacy. There have already been at least a half dozen companies before the end of 2010 that have gone before or will have their product undergo the scrutiny of an advisory panel prior to the FDA for approval of their drug or device. Vivus (VVUS) went before an FDA panel on July 15th for their drug Qnexa for obesity and it was voted 10-6 not approvable. Mela (MELA) had their advisory panel meeting rescheduled after it was originally scheduled for August 26th for their medical device for melanoma called the MELAFIND. The FDA had pushed the MELA meeting back to November as they needed time to assemble their advisory panel. Questcor (QCOR) was notified on June 11th that they had 2 months to prepare for an FDA meeting for Sept 11th where the FDA would decide on their drug, Athcar, for the treatment of infantile spasms. This FDA meeting was pushed back because the FDA stated they needed more time to review information regarding labeling and potential post-approval commitments that they solicited from Questcor. This is also after the May 6th Advisory Committee to the Division of Peripheral & Central Nervous System Drugs of the FDA voted in support of Athcar for approval. Arena Pharmaceuticals (ARNA) has an Advisory Panel Meeting for September 16th to discuss Locaserin for the treatment of obesity and their PDUFA date is Oct 22nd. Jazz (JAZZ) has an advisory committee meeting scheduled with the FDA on August 20th to discuss their drug Xyrem in fibromyalgia. Their scheduled PDUFA date is Oct. 11th. What does this Oct 11th date have to do with Alexza Pharmaceuticals? The importance is that date is the PDUFA date for Alexa's AZ-004 (Staccato Loxapine) where they will seek an indication for the rapid treatment of agitation associated with schizophrenia or bipolar disorder.Complete Story » seekingalpha.com |
Bears Take a Big Dose of Novartis optionMONSTER submits: By David Russell Novartis (NVS) has been rising sharply for almost two months, and but now one trader is positioning for a reversal. Complete Story » seekingalpha.com |
ERT to Present at Piper Jaffray's 22nd Annual Health Care Conference on December 1, 2010 [PR Newswire] - ERT announced today that Dr. Michael J. McKelvey, the Company's President and CEO, is scheduled to present at Piper Jaffray's 22nd Annual Health Care Conference at 12:00 PM EST on December 1, 2010 in New York City, New York. us.rd.yahoo.com |