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Genasense Trial Doesnt Meet Endpoints

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Genta says the AGENDA Phase 3 trial of Genasense failed to meet a co-primary endpoint and secondary endpoints.

Novartis H1N1 Vaccine Production Accelerating

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Novartis says it has almost tripled H1N1 vaccine yield after moving to a newer seed virus and production has been accelerating as ...

AstraZeneca Pulls Lung Cancer NDA

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AstraZeneca withdraws its NDA Zactima (vandetanib) 100mg in combination with chemotherapy that sought approval for use in patients...

Qualitest Recalls Accusure Syringes

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Qualitest Pharmaceuticals recalls all Accusure Insulin Syringes that have been distributed nationwide between 2002 and 2009.

Panel Recommends More ABthrax Tests

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Members of FDAs Anti-infective Drugs Advisory Committee say it is likely that Human Genome Sciences ABthrax may help treat people ...

FDA Clears Influenza Virus Detection Kit

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FDA clears a Diagnostic Hybrids 510(k) clearance for the D(3) FastPoint L-DFA Influenza A/ Influenza B Virus Identification Kit.

Latest Sidewiki Technology Can Create More FDA Questions

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Attorney Arnold Friede urges FDA to address legal liability questions arising out of Sidewikis appearing on drug company home page...

Revised Guidance on Structured Product Labeling

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Federal Register Notice: FDA releases a draft revised guidance, SPL Standard for Content of Labeling Technical Qs & As.

Science Advisory Board to Toxicological Center to Meet

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Federal Register Notice: FDAs Science Advisory Board to the National Center for Toxicological Research will meet 11/17-18 to provi...

Drug Companies Should Worry About WV Policy

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Attorneys James Beck and Mark Herrmann say a recent West Virginia federal court decision raises problems for drug companies due to...