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BioMed News Bytes: Genzyme, OSI Pharma, Pfizer, Seattle Genetics
GENZ
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<> 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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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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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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<> 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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<> 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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