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GENZ Analysis & Videos »
GENZ: Bull or Bear?
BioMed News Bytes: Genzyme, OSI Pharma, Pfizer, Seattle Genetics
GENZ
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+0.78%
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9 days
<> On 11/16/09, Genzyme (NASDAQ: GENZ) announced that it received a Complete Response Letter (CRL) from the FDA for its application to market Lumizyme (alglucosidase alfa) for the treatment of Pompe disease. The FDA stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed. The FDA co...
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Genzyme: Robust Growth Prospects at Clearance Sale Prices
GENZ
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+3.73%
in
101 days
(closed on 11/16/09)
In late July, Genzyme (NASDAQ:GENZ) reported 2Q09 results, including revenue of $1.23 billion (up 5% from $1.17 billion during 2Q08 and up 11% excluding unfavorable currency exchange rates). The Company's Non-GAAP net income (which excludes stock compensation and certain business acquisition items) rose to $232.5 million or $0.85 per diluted share versus $107 million or $0.38 per diluted share in the year-ago period. During 2Q09, Genzyme generated about $281 million in cash (primarily derived from operations) and used about $157 million (primarily for investments in manufacturing facilities...
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FDA Calendar Updates: Genzyme FDA Woes Benefit Protalix, Shire
GENZ
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-6.79%
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7 days
(closed on 08/07/09)
Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 293 entries as of 7/31/09. 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 clinical trial results. ...
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FDA, Clinical Trial Updates: GENZ, HGSI, LLY, NGSX
GENZ
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-11.86%
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71 days
(closed on 07/31/09)
<> 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
GENZ
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+10.29%
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8 days
(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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