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 Genzyme Corp.  (GENZ) Trade Now »     Rate GENZ  -  Discuss GENZ  -  Add to Watch List         Graphic_subscribe

       Sector: Healthcare  >  Industry: Biotechnology & Drugs
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Full Calendar of FDA Decisions Graphic_rating_buy GENZ
Mikerun
73%

Full FDA Calendar of Decision Dates

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The accompanying table [click to enlarge] includes an updated calendar of 73 expected FDA decision dates. Click here for my previous articles and FDA calendars , including several companies with expected decisions before year-end expected to have major stock price impacts, but keep in mind the backlog of delayed decisions that is building means that none of the dates are certain to produce final decisions.
<> Genzyme (GENZ) could hear back from the FDA as early as Monday for approval of Myozyme at the 2,000L b...
By  Mike Havrilla   (+1.04%  risk: conservative)  11/30/08 Comment


Updated 3-Month FDA Calendar Graphic_rating_buy GENZ
Mikerun
73%

Updated 3-Month FDA Decision Calendar

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The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (JNJ) and its Swiss partner, Basilea Pharma ( Switzerland: BSLN ) – sending the latter down sharply to new lows on Wednesday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.

The FDA cited conce...
By  Mike Havrilla   (+1.04%  risk: conservative)  11/29/08 Comment


ETFI Global Healthcare Sector PerformIdex Graphic_rating_buy GENZ
Mikerun
73%

ETFI Global Healthcare Sector PerformIdex

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The accompanying table presents the top six rated companies with market caps of at least $250 million (USD) from each of the eight ETFI healthcare indexes (which include a database of about 320 companies) as equally-weighted components in the ETFI Global Healthcare Sector PerformIdex of 48 companies.

1.) ETFI Global Hospitals
2.) ETFI New Drug Regulatory Catalyst
3.) ETFI Global AnimalBiz
4.) ETFI Health Benefit Providers
5.) ETFI Cosmetic & Reconstructive Medicine
6.) <> ETFI G...
By  Mike Havrilla   (+1.04%  risk: conservative)  11/08/08 Comment


Cosmetic & Reconstructive Medicine Companies Outpace the Healthcare Sector Graphic_rating_buy GENZ
Mikerun
73%

Cosmetic & Reconstructive Medicine Companies Outpace the Healthcare Sector

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<> The accompanying table presents the statistics and seven highest rated companies from the ETFI Global Cosmetic and Reconstructive Medicine [CRM] Index, which includes companies with market caps over $100M engaged in prescription skin care treatments, weight loss, cosmetic medicine, regenerative medicine, orthopedic repair, and joint replacements. Over the past year, the CRM Index fared better than the Healthcare Sector SPDR (XLV) and the S&P 500 SPDR (SPY) for the top 30 rated companies a...
By  Mike Havrilla   (+1.04%  risk: conservative)  11/01/08 Comment


FDA Action Heats Up Before Year-End Graphic_rating_buy GENZ
Mikerun
73%

FDA Action Heats Up Before Year-End

<>
The accompanying table presents an updated calendar of expected FDA decision dates and advisory committee [FDAC] meetings expected to impact the price of underlying biotech and pharma stocks. Genzyme (GENZ) faces a FDAC tomorrow (10/21) for its pending BLA for Myozyme manufactured at the 2,000L bioreactor scale. Also, Discovery Labs (DSCO) submitted its complete response to the FDA last Friday to address an approvable ruling for Surfaxin back in May and insiders continue to buy the stock. DSCO expects the FDA to rule on Surfaxin...
By  Mike Havrilla   (+1.04%  risk: conservative)  10/21/08 Comment



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