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GENZ Analysis & Videos »
GENZ: Bull or Bear?
FDA, Clinical Trial Updates: GENZ, HGSI, LLY, NGSX
GENZ
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-6.67%
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44 days
<> Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA fo...
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FDA, Clinical Trial Calendar Updates: Genzyme, Isis, Osiris, Roche, Watson
GENZ
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+12.12%
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29 days
(closed on 05/21/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete r...
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EXACT Sciences Announces New Management Team
GENZ
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-2.10%
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26 days
(closed on 04/13/09)
<> Posted by: Mike Havrilla in Untagged on Mar 18, 2009 <!-- Post Teaser Text --> <> MARLBOROUGH, Mass.--(BUSINESS WIRE)--EXACT Sciences (EXAS) today announced that the company's board of directors has appointed Kevin T. Conroy as president and chief executive, and Maneesh K. Arora as senior vice president and chief financial officer, effective April 2, 2009. Mr. Conroy is joining the company's board of directors immediately. <> Click here for my previous article on EXAS after the Genzyme (GENZ) dea...
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Updated Clinical Trial and FDA Decision Calendars
GENZ
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-20.30%
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24 days
(closed on 03/18/09)
Updated FDA and Clinical Trial Calendars By Mike Havrilla on 2/22/09 BioMedReports.com Below is a summary of updates to the FDA decision calendar since my last article, which includes a total of 90 entries through today: 1.) Nuvo Research (NRIFF.PK) (Canada: NRI.TO) NDA re-submission for Pennsaid - A topical NSAID for arthritis pain/inflammation - along with Paladin Labs (Canada: PLB.TO) <> 2.) Hemispherx Biopharma (HEB) Ampligen (Poly I: Poly C12U) NDA (three month PDUFA date delay announced 2/18/09 as additional data was submitted w...
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Healthcare Investing Trends in '09 and Beyond
GENZ
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+0.83%
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15 days
(closed on 02/22/09)
<> While the departure of Tom Daschle and concerns over rising unemployment and the global economic slowdown may hamper many of President Obama's plans for healthcare reform; there are several growth trends within the sector outlined below which are poised to benefit in 2009 and beyond. Follow any of the links below for more information on the new ETF Innovators indexes and exchange-traded fund ideas for the sector.
Global Health IT : The top five rated companies include Swiss telemedicine firm Card Guard (CDGUF) – a pro< />< />< />< /><>< />< />< />< /><><>< />< /><>< />< />< />< /><>...
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EXACT Sciences Forms Pact with Genzyme
GENZ
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+2.23%
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10 days
(closed on 02/07/09)
EXACT Sciences Forms Pact with Genzyme After the market close, EXACT Sciences announced that it formed a strategic pact with Genzyme (GENZ), which represents the grounds for the Board's refusal two weeks ago in response to Sequenom's (SQNM) hostile exchange offer at $1.50 per share in stock. The announcement followed news in the pre-market today that SQNM planned to commence its exchange offer through 3/24/09, valuing EXAS at $41M. <> However, the GENZ deal included the pur...
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Index to Track New Era for Stem Cell Cos.
GENZ
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+3.26%
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5 days
(closed on 01/28/09)
Index to Track New Era for Stem Cell Cos. Shares of Geron (GERN) are soaring today by more than 40% on FDA approval to begin human clinical testing this summer for an embryonic stem cell treatment for spinal cord injuries. The approval comes just days after the new administration took office, breathing new life into related companies such as StemCells (STEM), Aastrom Biosciences (ASTM), and others tracked in the ETF Innovators Cosmetic & Reconstructive Medicine Index. <> This index and new ETF idea represents a first-to-market idea to provide investors with an excha...
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Calendar of 163 FDA Decisions and Clinical Trials
GENZ
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-2.92%
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2 days
(closed on 01/23/09)
The tables at my web link below include an updated calendar of 80 expected FDA new product decisions and 83 pending clinical trial result estimates + pending FDA re-submissions. Click here for a link to my previous FDA calendars and the below is a summary of new entries and updates on the calendars. <> 1.) Genentech (DNA) expects to report results in mid-April in its Avastin colon cancer adjuvant trial, in addition to pending FDA decisions to expand product labels for Avastin in relaps...
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FDA Decision Date Calendar
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+10.29%
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(closed on 01/21/09)
<> 
<>
The accompanying table [click to enlarge] includes an updated calendar of expected FDA new product decisions with over 70 entries as a follow-up to my previous article on pending clinical trial results .
Click here for a link to my previous FDA calendars and the companies listed below have expected decisions within the next month or decisions which are overdue for a ruling by the agency.
1.) Schering-Plough (SGP): Saphris (asenapine) – nearly three months overdue
2.) Genzyme (GENZ): Synvis...
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FDA Calendar: Allergan's New Rx for Eyelashes
GENZ
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-5.02%
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15 days
(closed on 01/13/09)
<> 
The accompanying table [click to enlarge] includes an updated FDA calendar of 65 expected decision dates included in the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, with six companies listed in red with overdue decisions and the possibility for five decisions during the coming week. Click here for my previous FDA calendar articles and below is a review of recent decisions + a preview of the coming week:
1.) Allergan (AGN) received FDA approval on Friday for Latisse (bimatoprost solution 0.0...
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FDA Calendar: A Weekly Update
GENZ
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+0.09%
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23 days
(closed on 12/28/08)
<> 
The accompanying table [click to enlarge] presents an updated calendar of 73 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index. Below is a summary of the FDA action over the past week.
1.) ViroPharma (VPHM) – Filed a sBLA on 12/1/08 to expand use of Cinryze C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema [HAE], which is already FDA approved for regular use in the prevention of angioedema attacks in adolescent and adult patients with HAE. Standa< />< />< />< /><>< />< />< />< />< />< />< />< /><>< />< />< />< /><>...
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Full Calendar of FDA Decisions
GENZ
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+5.01%
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5 days
(closed on 12/05/08)
<> 
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...
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Updated 3-Month FDA Calendar
GENZ
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+0.00%
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1 day
(closed on 11/30/08)
<> 
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...
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