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Updated FDA Calendar of 73 Decision Dates

The accompanying table [click to enlarge or download] includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).

An FDA panel voted against Targanta's oritavancin, which has an upcomin

Updated FDA Calendar of Decision Dates

The accompanying table of FDA decision dates is updated to include the following: 1) XenoPort (XNPT) withdrew its NDA for restless leg syndrome drug Solzira for what appears to be a minor, administrative delay to reformat some trial data at the agency's request which will also delay $23M in milestone payments from partner GlaxoSmithKline (GSK); 2) Discovery Labs (DSCO) Surfaxin NDA will undergo a Class II review with a decision deadline pushed out to 4/17/09; 3) Genentech (DNA) filed for accelerated approval of Avastin as a s

A Backlog of Decisions is Building at the FDA

The accompanying table presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices.

Disco

Full FDA Calendar of Decision Dates

The accompanying table presents a full FDA calendar of decision dates updated through today, which I will maintain at the bottom of my blog in place of the previous Global Carbon Trading Index. Click on the calendar image above or on my blog to view or download the PDF version of the FDA calendar, which I will also maintain at: www.geocities.com/mikehavrx/fdac.pdf .

Several key decisions are pending through the end of this month for the group of 14 big pharma companies I outlined yesterday, including Eli Lilly (L

Filed under: Pfizer (PFE), Newsletters, Johnson and Johnson (JNJ), Abbott Laboratories (ABT), Bristol-Myers Squibb (BMY), Merck and Co (MRK), Lilly (Eli) (LLY), Stocks to Buy

"You can invest for all the right reasons and still get the wrong result," notes long-standing turnaround stock expert George Putnam, referring to the poor performance of the pharmaceutical sector in recent years.

Here, in his industry-leading The Turnaround Letter, he offers a fascinating review of 10 leading drug stocks which he now believes offer a combination of growth potential at "pretty cheap" valuations. Here is

Peak production of Comstock Lode silver was in 1877. This vein ofsilver, located in the mountains north of Reno Nevada, was thegranddaddy of all US Silver veins. (Virginia City of Bonanza fame wasthe mining town that built up at the base of the mountain.) Ultimately,more than $500 billion dollars worth of gold and silver (inflationadjusted) were pulled out of those hills. The first several groups ofmen to prospect the area made money but they all moved on to Californiabecause they heard about the big strikes there. Later, one of the firsttwo men who realized the vein was huge suffered leg a

I've done my diligence, even though I'm mostly testing  the site to see how the networking functions work. 

I started off  tongue-in-cheek with the advisor's wife liking Glaxo because they make migraine drug Imitrex, which has saved my life (and his) numerous times.  But in looking them over, I see robust neurosciences (mental health Rx) and cardiovascular pipelines which could benefit investors and the industry as well.  Also, only half tongue-in-cheek...   Brand strong, I recognized many of their available US drug names.

Glaxo has an environmental plan in place and claim 1

GlaxoSmithKline PLC is the world's second-largest pharmaceutical company has report solid 3Q earnings with a 15 percent jump. <o:p></o:p>

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Key Highlights:<o:p></o:p>

   Financials<o:p></o:p>

o        Net profit increased 15% for the 3Q to 1.39 billion pounds ($2.61 billion) <o:p></o:p>

o        Revenue rose 3 percent to 5.64 billion pounds ($10.6 billion)<o:p></o:p>

o        GSK’s management raised their full-year EPS Growth guidance for the year at 15%, from 12%.<o:p></o:p>

o        Plans for a 6 billion pound ($11.3 billion) share buyback program over three years, doubling i