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 October 2006 (v06-n10)
Main Story - Politics and the future of biotech - pgs. 1-17
Quick Mention: Myriad Genetics - pgs. 18-25
Macro Market Commentary - pgs. 26-31
Research Director's Corner - pgs. 32-35
BSR Coverage Update - pgs. 36-42
Biotech Sector Short Interest - pg. 43
BSR Model Portfolio - pgs. 44-45
(Full outline below...)

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October's Biotech Monthly handicaps the November elections and their impact on the upcoming PDUFA-4 negotiations. Biotech stocks are particularly sensitive to the rules laid out in the PDUFA regulations, and the current anti-pharma climate in the US means we could see significant changes in how drugs are approved and, especially, managed after approval.

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This issue goes through the major proposals one by one and discusses how they will affect the biotech space.

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The following is an outline of this issue of Biotech Monthly.
Main Story - Politics and the future of biotech
Background
Funding from industry bad?
Congress shirks responsibility
Table: FDA source of funding 1993-2004
Drugs aren't safe
Who wins on November 7
  • Senate
  • Table: Senate analysis - predicted outcome
  • House
  • Table: 2006 House race - "toss-up" seat analysis and predictions
  • Summary
  • Brave new regulatory world
    Kenzi bill
    REMS
    The Endless clinical Trial
    Will it happen?
    Interfering with advisory panels
    Will it happen?
    5-year safety reviews
    Matters to biotech?
    Will it happen?
    Marketing restrictions
    Will this happen?
    6-year Commissioner
    Will it happen?
    Price negotiation
    Effects on stocks
    Will this happen?
    Superiority and pharmacoeconomics
    Will it happen?
    Effect on biotech
    Non-biotech market impacts of election 2006
    Conclusions
    Quick mention: Looking in on Myriad Genetics (MYGN)
    Introduction
    Table: Basic facts
    Product portfolio
  • Genetic testing
  • Table: Molecular diagnostics products
  • Biopharmaceuticals
  • Table: Drug pipeline
  • Alzheimer's disease
  • Facts about US Flurizan study
  • Prostate cancer
  • Azixa and brain cancer
  • Thrombin inhibitor
  • Investment case

    Macro Market Commentary - "About as expected"

    Research Director's Corner - "FDA Guidelines on HCV clinical trials"

    Biotech Monthly Coverage Updates

    Adolor
    Investment case
    Dendreon
    P-11
    Forbes Medi-Tech
    Hana Biosciences
    Indevus
    Introgen
    Medarex
    Nabi
    NicVax competition
    Oncolytics biotech
    Seattle Genetics
    Table: Seattle Genetics Q3
    Investment case
    Sonus Pharmaceuticals

    Biotech Sector Short Interest

    BSR Model Portfolio Performance

     
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