ONC Recognizes New Mexico as First State to Successfully Obtain HIE Implementation Funds (PR Newswire)
New Mexico is the first state to meet all requirements for strategic and operational planning as part of the American Recovery and Reinvestment Act state health information exchange cooperative agreement program, according to the United States Office of the National Coordinator for Health Information Technology . us.rd.yahoo.com |
Three Trades on FDA, Clinical Trial Binary Events
Mike Havrilla submits:Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...Osiris Therapeutics (NASDAQ:OSIR) announced this morning that Health Canada has completed its initial evaluation and issued a priority (180-day) review for PROCHYMAL (remestemcel-L) (mesenchymal stem cells for intravenous infusion), which is seeking approval as an adult stem cell therapy for for the treatment of graft vs. host disease (GvHD).Complete Story » seekingalpha.com |
Alexza Financing Will Help Near-Term Milestones and Product Launch
Sheff Station submits:Alexza Pharma (ALXA) is anxiously awaiting a date with the FDA for a pre-approval inspection of its manufacturing facility in the late summer / early fall time period. This will ultimately be the last controllable detail for the company before the FDA decides on approval of AZ-004 for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder on Oct 11th. Biovail (BVF) is anxiously awaiting this meeting as well, as they are the North American partner for Alexza’s AZ-004.Alexza just conducted a stock offering of $2.70, which is almost 10% above Friday’s closing price of $2.46. The offering will close on August 10th. The surprise share offering gave some investors reason for worry, but as you will soon see it was necessary in order to achieve a potentially successful product launch of the AZ-004 come October and to prepare for other 2010 milestones.Complete Story » seekingalpha.com |
Array Biopharma: A Wall Street Anomaly
Ohad Hammer submits:Array’s (ARRY) shares keep on fluctuating in the $2.5-$3.5 range, relatively unchanged from the beginning of 2010. It seems that the market is having trouble assessing the real value of the company and its pipeline, which includes 13 (!) drugs in clinical trials. With a market cap of ~$170M, the market puts an average price tag of $13M per asset, a ridiculously low valuation (assuming no value is assigned to the company’s discovery platform). The company’s long term debt (due in 2014) could be partially blamed for this anomaly, but the problem seems to be more related to the company’s business model. The good news is that during the next year the company is looking at multiple events that might change the way Wall Street views Array.Array’s strength is also its Achilles’ heel: It has too many things going on and the majority of the programs are in early stage development without a clear and fast route to market. In that sense, the situation is very similar to that of Exelixis (EXEL), as I discussed two months ago. In order to get a realistic price tag from Wall Street, both companies must come up with a “killer app”, an indication that represents high probability of success, short time to market and a commercial opportunity of at least $100M. Although Array is not there yet, it could become highly attractive due to three trends: Out- licensing of wholly owned agents, maturation of partnered and proprietary programs and attrition.Maturing pipelineComplete Story » seekingalpha.com |
Sentara Wellness Payoff - Video
Employee Healthcare Just Got Less Expensive: Sentara Healthcare Saves $3.4 Million & Improves Employee Health feedproxy.google.com |