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       Sector: Healthcare  >  Industry: Biotechnology & Drugs
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FDA Calendar Updates: Amgen, Bayer, Biogen, Noveko, Peplin, Transdel Graphic_rating_buy BIIB
Mikerun
73%
 +1.42%
in 124 days
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 246 entries as of 7/8/09. 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 <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...
By  Mike Havrilla   (+1.04%  risk: conservative)  07/08/09 Comment


FDA Decision Calendar: Pain Drug Delays Likely Graphic_rating_buy BIIB
Mikerun
73%
 -12.22%
in 148 days
(closed on 07/08/09)
FDA Decision Calendar: Pain Drug Delays Likely
By Mike Havrilla on 2/9/09
ETF Innovators
 
The tables at my website link below include an updated calendar of 86 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.
 
 
New FDA Decision Calendar Entries:
 
<> 1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA...
By  Mike Havrilla   (+1.04%  risk: conservative)  02/10/09 Comment


Biogen Reports Another PML Case in Tysabri Patient Graphic_rating_buy BIIB
Mikerun
73%
 +29.15%
in 102 days
(closed on 02/10/09)

Biogen Reports Another PML Case in Tysabri Patient

<>
After the market close, Biogen (BIIB) filed an 8-K with the SEC reporting a new case of the potentially fatal brain disease known as PML or progressive multifocal leukoencephalopathy in a patient receiving their multiple sclerosis [MS] drug Tysabri, adding to the two new cases which were reported previously in July. Biogen is currently trading down by about 15% after hours while marketing partner Elan (ELN) is down by about 25% as of 5:15 PM. The news adds more uncertainty to Tysabri, which was removed from th...
By  Mike Havrilla   (+1.04%  risk: conservative)  10/30/08 Comment


Biogen Reports Another PML Case in Tysabri Patient Graphic_rating_buy BIIB
Mikerun
73%
 +0.00%
in 3 hours
(closed on 10/30/08)

Biogen Reports Another PML Case in Tysabri Patient

<>
After the market close, Biogen (BIIB) filed an 8-K with the SEC reporting a new case of the potentially fatal brain disease known as PML or progressive multifocal leukoencephalopathy in a patient receiving their multiple sclerosis [MS] drug Tysabri, adding to the two new cases which were reported previously in July. Biogen is currently trading down by about 15% after hours while marketing partner Elan (ELN) is down by about 25% as of 5:15 PM. The news adds more uncertainty to Tysabri, which was removed from th...
By  Mike Havrilla   (+1.04%  risk: conservative)  10/29/08 Comment


Biotech Blues: Four Stocks on Sale with Hope Graphic_rating_buy BIIB
Mikerun
73%
 -3.42%
in 4 days
(closed on 10/29/08)

Biotech Blues: Four Stocks on Sale with Hope

<> The following group of biotech companies have market caps of at least $300M with a one year stock price change that is below the iShares Nasdaq Biotech ETF (IBB) loss of 21.8% (Source: Google Finance, 10/25/08) with potential upside catalysts over the next year.

Alnylam Pharma (ALNY): $872M, -31.6%

Biogen Idec (BIIB): $12B, -48.4%

BioMarin Pharma (BMRN): $1.7B, -33%

Momenta Pharma (MNTA): $348M, -23.4%

Momenta and Novartis (NVS) expect to launch a generic version (M-Enoxaparin) of the injectable...
By  Mike Havrilla   (+1.04%  risk: conservative)  10/25/08 Comment




From the Blogosphere

Analyst upgrades, downgrades and initiations: CMCSA, CS, JWN, RCL, RIMM, YUM ...

Filed under: Analyst reports, Analyst upgrades and downgrades, Comcast Cl'A' (CMCSA), Research in Motion (RIMM), Yum Brands (YUM), Analyst initiations

Analyst upgrades:

<>
  • Jefferies upgraded Biogen (NASDAQ: BIIB) to Buy from Hold based on valuation. The firm, which has a $50 target on the stock, believes Tysabri PML cases are reflected in shares.
    • <>Deutsche Bank upgraded Nordstrom (NYSE: JWN) to Buy from Hold as it finds the valuation attractive and believes the company's sales are benefiting from stabilization in California and share gains. Deutsche raised its target on shares to $45 from ...
    By  Eric Buscemi   (+0.00%)  11/02/09 Comment


    Trading Radar for 10/20: Yahoo (YHOO), Coca-Cola (KO), Caterpillar (CAT), Bank of NY Mellon (BK), Coach (COH), Lexmark (LXK) Report
    The Trading Radar highlights key earnings and economic announcements for tomorrow's trading session:<u>Before Market Opens:</u>Economics:8:30am ET
    • Building Permits - Street Sees 590k
    • Core PPI - Street Sees 0.1%
    • Housing Starts - Street Sees 610K
    Earnings:Arbitron (NYSE: AIT) - consensus EPS $0.24Autolive (ALV) - consensus EPS $0.28Bank of New York Mellon (NYSE: BK) - consensus EPS $0.47Biogen Inec (NASDAQ: BIIB) - consensus EPS $1.04Blackrock (NYSE: BLK) - consensus EPS $1.90Caterpillar (NYSE: CAT) - consensus EPS $0.06Cirrus Logic (NASDAQ: CRUS) - consensus EPS $0.10Comerica (NYSE: CMA) - c...
    By  Street Insider   (+16.23%  risk: moderate)  10/19/09 Comment


    Options Update: CBOE Volatility Index S&P 500 Options-VIX closes at 13-month low

    Filed under: Options

    CBOE Volatility Index S&P 500 Options-VIX closed at 21.71; 10-day moving average is 24.37.

    Biogen Idec (NASDAQ: BIIB) closed at $49.79. BIIB is expected to report Q3 EPS on October 20 and give avonex outlook. BIIB November and January option implied volatility of 36 is near its 26-week average of 39 according to Track Data, suggesting non-directional price movement.

    Option Update is provided by Stock Specialist Paul Foster of theflyonthewall.com.

    <>Options Update: CBOE Volatility Index S&P 500 Options-VIX closes at 13-month low originally appeared on BloggingStocks on Fri, 16...
    By  Paul Foster   (+0.00%)  10/16/09 Comment


    Deal Modification for Elan, J&J
    28%
    We believe the dispute between Elan Corp. (ELN) and its US partner Biogen Idec (BIIB) over the multiple-sclerosis drug Tysabri has been resolved at last.
    By  reity   (-33.96%  risk: aggressive)  09/28/09 Comment


    Deal Modification for Elan, J&J
    We believe the dispute between Elan Corp. (ELN) and its US partner Biogen Idec (BIIB) over the multiple-sclerosis drug Tysabri has been resolved at last.
    By  Zacks.com   (-15.10%  risk: moderate)  09/28/09 Comment



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    Discussion Wall + Add  
    amritadas   (+0.00%)
    A FREE report on the approval of a new Gout Drug - FDA Panel to review this Biotech company's stress agent drug on July 28th. If they get a favorable backing by the panel, the chances of approval by th...
    +   0 replies

    amritadas   (+0.00%)
    Free report on upcoming FDA panel decision of Corvu.. - FDA Panel to review this Biotech company's stress agent drug on July 28th. If they get a favorable backing by the panel, the chances of approval by th...
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