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Saturday, November 21, 2009 7:25 PM

Biologics License Application

Type: Keyphrase
Name: Biologics License Application
First Reported 11/20/2009 - Updated 11/20/2009 - 2 Documents (in Medicine)
Dendreon Gets FDA Acceptance For Prostrate Cancer Drug Application - Update
TOP MARKET NEWS(RTTNews) - Friday, biotechnology company Dendreon Corp. (DNDN: News ) revealed that the U.S. Food and Drug Administration or FDA has accepted its amended Biologics License Application or BLA to market its candidate vaccine Provenge for ... [RTTNews.com - 11/20/2009]
First Reported 11/16/2009 - Updated 11/17/2009 - 5 Documents
Food and Drug Administration - Click to view 360-page
Food and Drug Administration
Human genome sciences receives complete response letter from fda for raxibacumab biologics license application
Human Genome Sciences ... [MDLinx - 11/17/2009]
First Reported 11/14/2009 - Updated 11/14/2009 - 1 Documents (in Health)
Novartis AG - Click to view image in its original context
Novartis AG
Glaxo H1N1 Vaccine Approved
(Zacks.com via COMTEX) -- GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), ... [TMC Net - 11/14/2009]
First Reported 11/16/2009 - Updated 11/16/2009 - 1 Documents
Glaxo Receives Approval for Its H1N1 Vaccine
Zacks.com submits: GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), ... [Healthcare Sector and Stocks Analysis from Seek ... - 11/16/2009]
First Reported 11/02/2009 - Updated 11/02/2009 - 3 Documents
Dendreon (DNDN) Completes Submission of Biologics License Application for PROVENGE
Visit StreetInsider.com at http://www.streetinsider.com/FDA/Dendreon+%28DNDN%29+Completes+Submission+of+Biologics+License+Application+for+PROVENGE/5063276.html for the full story. ... [Street Insider - 11/02/2009]
First Reported 10/30/2009 - Updated 10/30/2009 - 2 Documents
U.S. Food and Drug Administration Issues Complete Response Letter Regarding PEGINTRON(R) for Malignant Melanoma
KENILWORTH, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Schering-Plough Corp. (NYSE: SGP) announced today the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding ... [Individual.com - 10/30/2009]
First Reported 11/02/2009 - Updated 11/02/2009 - 2 Documents
Dendreon Corporation - Click to view 360-page
Dendreon Corporation
BRIEF-Dendreon says completes submission of BLA for PROVENGE
Nov 2 (Reuters) - Dendreon Corp:* Completes submission of biologics license application for PROVENGE* Says amended BLA includes data from the impact trial* Says is seeking licensure for provenge for men with metastaticcastrate-resistant prostate canc ... [Forbes.com - 11/02/2009]
First Reported 11/03/2009 - Updated 11/03/2009 - 2 Documents
United States : U.S. Food And Drug Administration Issues Complete Response Letter Regarding PEGINTRON(R) For Malignant Melanoma
Schering-Plough Corp. (NYSE: SGP) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON (R); (pegylated interferon alfa-2b) for the adjuvant ... [Individual.com - 11/03/2009]
First Reported 11/05/2009 - Updated 11/05/2009 - 1 Documents
Lower Third Quarter Loss for Human Genome
Human Genome Sciences, Inc. (HGSI) reported third quarter net loss of $49 million or 32 cents per share, in-line with the Zacks Consensus Estimate. The company reported a net loss of $74.2 million or 50 cents in the year ago quarter. The lower net loss ... [Seeking Alpha - 11/05/2009]
First Reported 11/10/2009 - Updated 11/10/2009 - 1 Documents (in Health)
BRIEF-Glaxo wins FDA approval for H1N1 swine flu vaccine
NEW YORK, Nov 10 (Reuters) - GlaxoSmithKline PLC:* FDA approves supplemental biologics license application for unadjuvanted H1N1pandemic vaccine* H1N1 unadjuvanted vaccine was filed as a strain change supplement to FluLavalseasonal flu vaccine(For more ... [Forbes.com - 11/10/2009]
First Reported 11/11/2009 - Updated 11/11/2009 - 1 Documents
Dendreon loses $45.6M in Q3
Dendreon Corp. reported a third-quarter loss of $45.6 million, or a loss of 40 cents per share, which compares with a loss of $26.8 million, or a loss of 29 cents a share a year earlier.Revenue was $25,000 in the latest quarter compared with $26,000 in ... [Biz Journals - 11/11/2009]
First Reported 10/22/2009 - Updated 10/22/2009 - 1 Documents
Shire plans to file biologics license application for Replagal
Shire, a UK-based specialty biopharmaceutical company, has announced that it plans to file a biologics license application or BLA with the FDA for Replagal, its enzyme replacement therapy for Fabry disease, by the end of 2009.The company also announced ... [Individual.com - 10/22/2009]

Quotes

...plan to address the current questions as well," said Sally D Bolmer, Ph D , R A C, Senior Vice President, Development and Regulatory Affairs, HGS. "In certain respects, the Complete Response Letter appears to be inconsistent with the FDA's published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible." Raxibacumab is a first-in-class treatment for anthrax, and the first procurement under Project BioShield of a product discovered and developed after...
Human Genome (HGSI) Receives U.S. FDA Response Letter for Anthrax Treatment Raxibacumab [Street Insider - 11/16/2009]
...melanoma, with a view to submitting a Biologics License Application filing in mid 2011," said Philip Astley-Sparke, President and CEO of BioVex. "We believe this over-subscribed funding round is the largest for a private clinical stage biotech company this year and is a validation of our clinical and regulatory achievements. We have generated encouraging data in four tumor types and beyond melanoma have agreed to an additional Phase III pivotal protocol with the FDA under the Special Protocol Assessment procedure in head and neck cancer."
BioVex Completes $70 Million Financing to Conclude Pivotal Study With Its Pioneering Cancer ... [PipelineReview - 11/11/2009]
...a response on the Biologics License Application that was submitted by our partner, Auxilium," stated Thomas L Wegman, President of BioSpecifics. "We also look forward to the Phase IIb results testing XIAFLEX in Peyronie s disease, which Auxilium expects to report in December."
BioSpecifics Technologies revenues increases by 100% for the third quarter ended September 30, 2009 [News-Medical.Net - 11/07/2009]

More Content

All (149) | News (135) | Reports (0) | Blogs (12) | Audio/Video (0) | Fact Sheets (2)
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Dendreon Corporation (DNDN) (JOBS) Receives FDA... [BioSpace - 18 hours ago]
Panel: FluBlok Safety, Efficacy Data Insufficie... [BioWorld - 11/20/2009]
BioMed News Bytes: CombinatoRx, Dendreon, Photo... [SocialPicks - 11/20/2009]
Dendreon Gets FDA Acceptance For Prostrate Canc... [RTTNews.com - 11/20/2009]
FDA acknowledges Dendreon's amended BLA for PRO... [News-Medical.Net - 11/20/2009]
Market Report -- In Play (DNDN) [Briefing.com via MSN Money - 11/20/2009]
Dendreon Corp. (DNDN) Receives U.S. FDA Complet... [Street Insider - 11/20/2009]
Dendreon Receives FDA Acknowledgement of Comple... [FinanzNachrichten.de - 11/20/2009]
GSK donates flu vaccine to the WHO [Pharmaceutical Technology - 11/20/2009]
HGSI's ABthrax Faces FDA Delay [Individual.com - 11/19/2009]
US FDA seeks additional information from HGS's ... [PharmaBiz - 11/18/2009]
Human genome sciences receives complete respons... [MDLinx - 11/17/2009]
Zacks Analyst Blog Highlights: GlaxoSmithKline ... [Business Wire - 11/16/2009]
BioMed News Bytes: Genzyme, OSI Pharma, Pfizer,... [SocialPicks - 11/16/2009]
UPDATE 2-FDA denies approval for Human Genome's... [Reuters UK - 11/16/2009]
BioMed News Bytes: Cytori, Poniard, Alkermes, S... [SocialPicks - 11/16/2009]
Human Genome Sciences Receives Complete Respons... [RTTNews.com - 11/16/2009]
FDA issues a Complete Response Letter for Human... [News-Medical.Net - 11/16/2009]
Human Genome (HGSI) Receives U.S. FDA Response ... [Street Insider - 11/16/2009]
Human Genome Receives Complete Response Letter ... [RTTNews.com - 11/16/2009]
Human Genome Sciences Receives Complete Respons... [Forbes.com - 11/16/2009]
Human Genome Sciences Receives Complete Respons... [Business Wire via MSN Money - 11/16/2009]
Human Genome Sciences Receives Complete Respons... [Business Wire - 11/16/2009]
Glaxo H1N1 Vaccine Approved - Zibb.com [Zibb - 11/14/2009]
Glaxo H1N1 Vaccine Approved [TMC Net - 11/14/2009]
BioVex Completes $70 Million Financing [Nanotechnology News - 11/14/2009]
H1N1 influenza infects 22 million Americans in ... [Pharmacist.com - 11/13/2009]
FDA approves GSK's pandemic H1N1 vaccine [World Pharma News - 11/12/2009]
Nov 11 GSK news release [Centre For Infectious Disease Research and Policy - 11/12/2009]
Dendreon loses $45.6M in Q3 [Biz Journals - 11/11/2009]
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In Focus
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Armando Anido, Sylvie Gregoire, Sheila Burke, [more]
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Dendreon Corporation, Human Genome Sciences Inc, Shire plc, [more]
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Food and Drug Administration, United States Department of Health an ..., Biomed, [more]
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complete response, Raxibacumab, Anthrax, [more]
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London, Seattle, Bangalore, [more]
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United States, Japan, United Kingdom, [more]
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Medicine, Biology, Diseases, [more]
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Pharma & Biotech, Health, IT, [more]
PharmaBiz, Street Insider, Individual.com, [more]
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Glaxo Receives Approval for Its H1N1 Vaccine [Healthcare Sector and Stocks Analysis from Seek ... - 11/16/2009]
Zacks.com submits: GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) ...
BioMed News Bytes: Dyax, Human Genome Sciences,... [IPO Analysis from Seeking Alpha - 10/29/2009]
Mike Havrilla submits:The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical ...
BioMed News Bytes: Dyax, Human Genome Sciences,... [Healthcare Sector and Stocks Analysis from Seek ... - 10/29/2009]
Mike Havrilla submits:The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical ...
BioMed News Bytes: Dyax, Human Genome Sciences,... [Biotech Sector and Stocks Analysis from Seeking ... - 10/29/2009]
Mike Havrilla submits:The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical ...
FDA Calendar Updates: Transcept Pharma Surges o... [Biotech Sector and Stocks Analysis from Seeking ... - 08/03/2009]
Mike Havrilla submits:Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 297 entries as of 8/3/09.. I originally created ...
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