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Fdanewsdrugdailybulletin

Jan. 12, 2005

Vol. 2 No. 8

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CONGRESSMAN CALLS FOR PROBE OF FDA's KNOWLEDGE OF PROZAC RISKS

A Democratic congressman has asked the FDA to investigate what it knew about certain Eli Lilly documents from the mid-1980s that allegedly showed a link between suicidal behavior and the antidepressant Prozac.

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SECURITIES SUITS CONCERNING PRODUCT LIABILITY ON THE RISE, REPORT SAYS

Federal securities class action lawsuits involving product liability claims, such as those filed against Merck and Pfizer, may represent a growing trend in the class action field, according to a new report.

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FDA REOPENS COMMENT PERIOD FOR TWO ICH GUIDANCES

Prompted by a request from Wyeth, the FDA has reopened the public comment period for two International Conference on Harmonisation (ICH) draft guidances that assess possible cardiac risks associated with new drugs.

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FORMER FDA CHIEF COUNSEL TROY JOINS LAW FIRM

Former FDA Chief Counsel Daniel Troy has accepted a position with law firm Sidley Austin Brown.

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PERLEGEN SCIENCES TO COLLABORATE ON PHARMACOGENOMICS STUDY WITH JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT

Perlegen Sciences will commence a pharmacogenomics collaboration with Johnson & Johnson Pharmaceutical Research and Development (J&JPRD), a Johnson & Johnson company.

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BRITISH COMPANY BUYING APTAMERA FOR $21.4 MILLION

Aptamera, a three-year-old Louisville biotechnology company that is working to develop anticancer drugs, has agreed to be acquired by Antisoma, a biotechnology firm based in the UK.

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SIRNA THERAPEUTICS AND TARGETED GENETICS FORM HUNTINGTON'S DISEASE COLLABORATION

Sirna Therapeutics and Targeted Genetics have established a collaboration to develop a novel therapy for the treatment of Huntington's Disease (HD), an incurable neurodegenerative disorder.

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GSK BIO TARGETS INDIA FOR R&D

GlaxoSmithkline Biologicals, the vaccine business of pharma major GlaxoSmithKline (GSK), will make India a global hub for clinical research and development.

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SANOFI-AVENTIS AND REGENERON PHARMACEUTICALS REAFFIRM DEVELOPMENT COMMITMENT

Sanofi-aventis has announced that, following a review of the Vascular Endothelial Growth Factor (VEGF) Trap program, it has reaffirmed its commitment to develop the VEGF Trap in oncology in collaboration with Regeneron Pharmaceuticals.

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GERON ANNOUNCES LICENSE AGREEMENT WITH CAMBREX

Geron has announced a worldwide license agreement between Geron and Cambrex Bio Science Walkersville, under which the Cambrex subsidiary will develop and distribute cell lines that have been immortalized using Geron's proprietary telomerase technology.

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APPLIED BIOSYSTEMS EXPANDS WORK WITH UM

A California company said it has expanded its collaboration with the University of Miami and Stanford University to study genetic biomarkers associated with treatment response and survival in the most common form of non-Hodgkin's lymphoma.

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PHARMA INDUSTRY INJECTS $3 MILLION INTO ALBANY RESEARCH INSTITUTE

The Pharmaceutical Research Institute has received nearly $3 million in donated laboratory equipment since establishing its headquarters at the Albany College of Pharmacy in 2003.

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