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       Sector: Healthcare  >  Industry: Major Drugs
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BioMedReports FDA Calendar: Swine Flu Trial Set to Begin Graphic_rating_buy NVS
Mikerun
73%
<> 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...
By  Mike Havrilla   (+1.04%  risk: conservative)  07/21/09 Comment


Updated FDA, Clinical Trial Calendars: AZN, MYGN, NVS, PSDV Graphic_rating_buy NVS
Mikerun
73%
Below is a summary of updates to the BioMedReports.com database of 240 entries included in the FDA and Clinical Trial Calendars .
 
 
<> 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 113 entries through 4/8/09. The FDA Calendar includes the following information: company name, ticker, decision ...
By  Mike Havrilla   (+1.04%  risk: conservative)  04/08/09 Comment


A Resurgence in Cell Therapeutics Graphic_rating_buy NVS
Mikerun
73%
Since I profiled Cell Therapeutics (CTIC) two months ago as a cancer biotech that was down, but not out; the stock price has more than quadrupled from 8 cents to 36 cents during intraday trading today. CTIC continues to reduce operating expenses and sold its remaining stake in a joint venture to market cancer drug Zevalin to Spectrum Pharma (SPPI) for $16.5M last month (in addition to receiving $15M last December from SPPI for the initial 50% stake).
 
 
<> CTIC reduced operating expenses in 2008 by 33% and prov...
By  Mike Havrilla   (+1.04%  risk: conservative)  04/02/09 Comment


Updated Clinical Trial and FDA Decision Calendars Graphic_rating_buy NVS
Mikerun
73%
<> <> Below is a summary of updates to the www.BioMedReports.com database of 242 entries included in the FDA and Clinical Trial Calendars. The two web links below are for the FDA calendar home page and a recent article highlighting 14 extreme trades of companies with market caps below $200M with pending FDA decisions.

http://biomedreports <wbr> </wbr> .com/fda-calendar.ht <wbr> </wbr> ml

http://biomedreports <wbr> </wbr> .com/articles/most-p <wbr> </wbr> opular/627-trading-f <wbr> </wbr> da-decisions-14-extr <wbr> </wbr> eme-trades.html

The FDA Calenda...
By  Mike Havrilla   (+1.04%  risk: conservative)  03/15/09 Comment


Momenta Pharma's Three-Part Strategy Graphic_rating_buy NVS
Mikerun
73%
Momenta Pharma (MNTA) is pursuing a three-part business model which includes complex generic equivalents in partnership with the Sandoz division of Novartis (NVS), proprietary compounds, and follow-on- biologics (FOB).
 
<> Momenta is partnered with Sandoz to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company is set to expire on 4/1/09 for Amphasta...
By  Mike Havrilla   (+1.04%  risk: conservative)  03/06/09 Comment



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