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December 2007FeaturesCover Story Cancer Vaccines: A Century in the Making... Almost Here?Cancer immunotherapeutics, including vaccines, may hit the market by the end of this decade. They promise longer survival and perhaps indefinite remission at a more favorable cost-benefit ratio than that of oncologics now in use. They also may fuel dramatic changes in how healthcare is delivered and financed. Business Convergence in the Midst of CompetitionAs biotechs hit their adolescence, they — like test makers and pharmaceutical manufacturers — are more likely than ever to reach outside of their own areas of expertise, link hands with the other guys, and pursue new programs and technologies. Policy Biopharmaceuticals: The Economic EquationAs more biopharmaceuticals reach the market, more attention will be given to issues such as cost-effectiveness evaluations, biosimilars, and price controls. The value biologic therapies bring to the healthcare system may take years to appreciate in full — perhaps only when policy decisions allow for their economic effects to be understood. Diagnostics A Wish List for Molecular TestsCompanion diagnostics improve health outcomes, say developers, who are willing to work with payers to develop medical policies for coverage. Payers and clinicians want more evidence of long-term benefit. The FDA, meanwhile, is jostling for regulatory control. How long will patients have to wait? Part 2 of 2 Regulatory Lower Cost and Faster Product Approval Through Proper Software Design ControlsThe market success of a medical device depends in large part on how well its software is programmed. Focusing heavily on the device while treating the software as an afterthought can lead to costly recalls and liability concerns. DepartmentsOpeners Some Predictions for 2008Looking ahead to 2008. Editorial The Biotech Detail Rep of the FutureDavid B. Nash, MD, MBA, on the detail rep of tomorrow. Washington Watch Money-Back Guarantees: Where Private Payers Might Not Wait for CMS To LeadPay for performance, pharma style. Diagnostics and Devices Ousting the ‘Ouch Factor’ in Drug DeliveryPointers on perfecting drug delivery. DrugTrack Approvals, FDA Actions, Clinical TrialsFDA approvals and other actions, plus results of key clinical trials. Biotech Business Employers Work To Manage Biologics in 2008 Benefit DesignsBenefit designs for 2008. Conference Coverage Making an Impression on Biotech DevelopmentLife imitates art. Trends: Specialty Pharmacy Additional Indications Drive Higher Specialty SpendingMultiple indications boost SP spending. |
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