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Government sponsored comparative effectiveness research is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans – with step one in the process being unfettered (and unregulated) communications efforts. Unless we are aware and vigilant, such cost-think may very well lead to a single-payer system referred to in cost-think as “universal coverage” – but in reality will be nothing short of healthcare rationing. There are many dangerous implications, but the most frightening is the chilling effect so-called comparative effectiveness programs will have on the future of healthcare innovation.

Full details at the Journal of Commercial Biotechnology

This paper examines the valuation of biotechnology firms and measure firm value relative to the firms’ drug development pipelines, alliances with other firms, and the varied composition of those firms’ boards of directors.  Unsurprisingly, the advancement of drugs in the pipeline is associated with increased valuation, and the failure of drugs in testing is found to have negative impacts.  Findings do not support the notion that companies engaged in partnerships or alliances have better performance. Extending prior research, the study finds that the presence of medical doctors on the boards of directors is significantly positively associated with the price-to-book ratio and firm value. Drug approvals seemed less likely for small cap firms; this outcome is likely the result of small cap firms with more promising prospects being acquired, and exiting “small cap” status. Among other findings, a higher number of drug approvals among such targeted diseases as AIDS and cancer are observed; modestly higher approval rates are observed in concert with a relatively higher proportion of financiers – such as hedge fund managers and investment bankers – on biotechnology boards.  Findings are important to the investor, the biotechnology manager and the regulator.

Full details at the Journal of Commercial Biotechnology

This paper examines the valuation of biotechnology firms and measure firm value relative to the firms’ drug development pipelines, alliances with other firms, and the varied composition of those firms’ boards of directors.  Unsurprisingly, the advancement of drugs in the pipeline is associated with increased valuation, and the failure of drugs in testing is found to have negative impacts.  Findings do not support the notion that companies engaged in partnerships or alliances have better performance. Extending prior research, the study finds that the presence of medical doctors on the boards of directors is significantly positively associated with the price-to-book ratio and firm value. Drug approvals seemed less likely for small cap firms; this outcome is likely the result of small cap firms with more promising prospects being acquired, and exiting “small cap” status. Among other findings, a higher number of drug approvals among such targeted diseases as AIDS and cancer are observed; modestly higher approval rates are observed in concert with a relatively higher proportion of financiers – such as hedge fund managers and investment bankers – on biotechnology boards.  Findings are important to the investor, the biotechnology manager and the regulator.

Full details at the Journal of Commercial Biotechnology

All stake-holders in the pharmaceutical industry recognise that valuable new medicines can be obtained from investing in the research and development of new uses for existing drugs.  The present system of awarding second medical use patents to originators which develop new and inventive medicines from known drugs does not provide sufficient incentive to this part of the industry.  Moreover the status of second medical use patents is so uncertain that generics do not know where they stand.  A solution which provides proper protection to second medical use patents is required to bring certainty and fairness to all involved in the industry to the ultimate benefit of patients. Full details at the Journal of Commercial Biotechnology

All stake-holders in the pharmaceutical industry recognise that valuable new medicines can be obtained from investing in the research and development of new uses for existing drugs.  The present system of awarding second medical use patents to originators which develop new and inventive medicines from known drugs does not provide sufficient incentive to this part of the industry.  Moreover the status of second medical use patents is so uncertain that generics do not know where they stand.  A solution which provides proper protection to second medical use patents is required to bring certainty and fairness to all involved in the industry to the ultimate benefit of patients. Full details at the Journal of Commercial Biotechnology

It costs about $1.2 billion to bring a single new drug to market in the U.S. today.[1] With a combination of high late-stage failure rates and the high cost of drug trials, the number of new drugs being approved by the FDA has flat-lined at historically low levels, falling from 53 in 1996 to just 19 in 2009.[2] If the cost of drug trials doesn’t come down, we will see far fewer new drugs on pharmacy shelves.



[1] Pharmaceutical Research and Manufacturers of America Profile 2009. Washington, DC: PhRMA.

[2] Hughes B. 2009 Drug Approvals. Nature Reviews Drug Discovery 9, 89-92 (February 2010)

Full details at the Journal of Commercial Biotechnology

The purpose of this study was to apply net present value (NPV) modelling to evaluate the financial attractiveness and business risk of different categories of biosimilars. Challenges and opportunities of biosimilars are compared with those of standard small molecule generics. Minimum peak sales levels are required to create financial value were determined in order to derive recommendations for the selection of commercially rewarding biosimilar development candidates.

Full details at the Journal of Commercial Biotechnology