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BioMedReports FDA Calendar: Swine Flu Trial Set to Begin
GSK
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+8.73%
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124 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
GSK
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+5.62%
in
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
GSK
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+8.41%
in
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
GSK
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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
GSK
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+4.33%
in
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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From the Blogosphere
Biogen’s Rituxan Label Expansion Delayed – Analyst Blog
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Biogen Idec (BIIB) and Genentech, Inc., a wholly-owned member of the Roche Group (RHHBY.PK), announced that they have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for Rituxan. The companies were seeking approval for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL).
Although the companies did not provide any details regarding the letter, they said that the agency has not asked them to submit any new data. Genentech and Biogen intend to w...
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Panel Backing for Prevnar 13 – Analyst Blog
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Pfizer (PFE) announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products advisory committee voted in favor (10 to 1) of data presented to support the safety and effectiveness of Prevnar 13, its 13-valent pneumococcal conjugate candidate vaccine. The favorable recommendation of the vaccine was based on data from 13 phase III studies carried out on more than 7,000 children.
Pfizer is seeking FDA approval for the vaccine to prevent diseases (including sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema caused by 13 Streptococcus pneumoni...
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Anti-Smoking Vaccine from Glaxo – Analyst Blog
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GlaxoSmithKline (GSK) and Nabi Biopharmaceuticals (NABI) signed a licensing agreement for a nicotine conjugate vaccine (NicVAX) as well as for the development of a second generation nicotine vaccine. NicVAX is an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse. Earlier in October, the vaccine received a $10 million grant from the National Institute on Drug Abuse. <>As per the agreement, Nabi will get an upfront payment of $40 million and is eligible to receive more than $500 million (together with upfront payment) as option fees and milesto...
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Zacks Analyst Blog Highlights: GlaxoSmithKline plc, Sanofi-Aventis, Novartis, Baxter International and AstraZeneca – Press Releases
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For Immediate Release Chicago, IL – November 16, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: GlaxoSmithKline plc (GSK), Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN). Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513 Here are highlights from Friday’s Analyst Blog: <><>Glaxo...
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Glaxo H1N1 Vaccine Approved – Analyst Blog
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GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This means that Glaxo can now market its swine flu vaccine for use in adults to prevent influenza.
The company has already received an order for 7.6 million doses of its swine flu vaccine from the United States Department of Health and Human Services. This order is ...
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