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GSK Analysis & Videos »
GSK: Bull or Bear?
BioMedReports FDA Calendar: Swine Flu Trial Set to Begin
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+10.85%
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127 days
<> Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 265 entries as of 7/21/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com <> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinica...
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FDA Calendar Updates: BDSI is Worth the Wait, Zicam Warning
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+5.62%
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35 days
(closed on 07/21/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st...
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FDA Calendar Updates: MITI, KERX, GSK, DYAX, ARNA, PGNX
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+8.41%
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8 days
(closed on 06/16/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of about 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-s...
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FDA, Clinical Trial Calendar Updates: Weight Loss, Diabetes, and More
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+6.87%
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68 days
(closed on 06/08/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 110 entries through 4/1/09. The FDA Calendar includes the following information: company name, ticker, decision d...
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A 130/30 Pharma Trade
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+4.33%
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40 days
(closed on 04/01/09)
By Mike Havrilla on 2/20/09 ETF Innovators The tables at my website link below include 12 U.S. listed companies from the ETF Innovators Global Generic Drug Index along with seven brand drug companies, which are ranked in descending order based on their patent expiration exposure through the end of 2011 as a percentage of total trailing 12-month revenue. <> Investors who are bullish on the generic drug industry may consider implementing a 130/30 pharma trade by shorting any/all...
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Global Q&A: A rebound-ready portfolio
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+13.96%
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342 days
Filed under: International markets, Barclays plc ADS (BCS), Rio Tinto plc ADS (RTP), Stocks to Buy  I am the Global Editor at MoneyShow.com and each week I interview an investing expert. This week, I spoke with Chris Gilchrist, editorial director of EveryInvestor, who tells investors how they should protect themselves, diversify, and position their portfolios for a rebound.
Q. Chris, in an interview at the recent World Money Show in London, you discussed the failure of the most widely used diversification strategies during the current global market declines. Why did it happen? <>A. There are two ...
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Achillion Pharma: Funding in Place to Advance HCV Pipeline
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-5.51%
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86 days
(closed on 02/20/09)
<> Achillion Pharma (ACHN) is a promising micro-cap biotech, specializing in the development of new treatments for infectious diseases, such as the multi-billion dollar market for the chronic treatment of hepatitis C. As I recently wrote , several companies in this space have been bought out at huge premiums over the past year – including an astounding premium of over 400% for a $57M buyout by GlaxoSmithKline (GSK) of hepatitis C virus [HCV] developer Genelabs (GNLB).
Since completing a $41.5M private place...
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Updated FDA Calendar of 73 Decision Dates
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+2.71%
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3 days
(closed on 11/25/08)
<> 
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...
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Updated FDA Calendar of Decision Dates
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-5.97%
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9 days
(closed on 11/22/08)
<> 
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...
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A Backlog of Decisions is Building at the FDA
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-7.01%
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6 days
(closed on 11/13/08)
<> 
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...
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Full FDA Calendar of Decision Dates
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-18.79%
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16 days
(closed on 10/11/08)
<> 
<> 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...
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GSK, Sirtris, Resveratrol, and research..very interesting!
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-12.17%
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469 days
I'm no expert, and I don't know all that much about stock choices, but this one just hit me over the head, after doing the technical research about the new product the medical communities are now investigating, Resveratrol(not a new product, but new testing is accelerating by some of the best in the industry!). Glaxo is also adding a new immunization line of products that competes with some of the others, and it is also a new-ish product related to diminishing the chances of developing cervical cancer.
New medical research is always interesting to me, so I'm basically just looking a< />< /><>< /><>...
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GlaxoSmithKline plc
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-12.64%
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502 days
GlaxoSmithKline plc, together with its subsidiaries, engages in the creation, discovery, development, manufacture, and marketing of pharmaceutical and consumer health-related products. Its Pharmaceuticals segment manufactures prescription drugs and vaccines that are used in various therapeutic areas, including central nervous system, respiratory, anti-viral, anti-bacterial, oncology and emesis, metabolic, cardiovascular, and urogenital. This segment offers Seretide/Advair for asthma and chronic obstructive pulmonary disease (COPD); Avandia for the treatment of type 2 diabetes; Lamictal for ...
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Glaxo Now at Reasonable Value
GSK
-4.28%
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518 days
We continue to like the fundamentals at Glaxo and with the Avandia issue already baked into the stock price, the shares look fairly valued.
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Solid performer
GSK
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-0.80%
in
528 days
I would rate Glaxo pretty strong. It has been a strong performer for a long time and only recently has the stock underperformed along with the broad contours of the stock markets. The pharma sector has been hit by few problems but those should not really affect this company. GlaxoSmithkline has a well diversified portfolio and is well positioned to take advantage of it.
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