Nature reviews. Drug discovery
-
Cetuximab (Erbitux; ImClone Systems/Bristol-Myers Squibb) is a monoclonal antibody that binds to the epidermal growth factor receptor, which is important in the growth of many cancers. In February 2004, it was granted accelerated approval by the US FDA for the treatment of metastatic colorectal cancer on the basis of tumour response rates in Phase II trials.
-
Oncology, as a therapeutic area, is characterized by a desperate medical need for new drugs; the use of drugs that kill cells and which are consequently often toxic; and rates of failure in expensive Phase III trials that eclipse many other disease areas. The poor performance of most investigational cancer drugs implies that the standard preclinical disease models are faulty or, at least, improperly used. Some studies, however, support the view that cancer models can be highly effective, but only when selected and interpreted with care.
-
Nat Rev Drug Discov · Feb 2005
ReviewPricing medicines: theory and practice, challenges and opportunities.
The pricing of medicines has become one of the most hotly debated topics of recent times, with the pharmaceutical industry seemingly being attacked from all quarters. From a company perspective, determining the price for each new product is more crucial than ever, given the present dearth of new drug introductions. But how are pricing strategies developed in practice? What is value-based pricing and how are financial models of return on investment constructed? What are the challenges faced in setting the price for a particular product, and how will scientific and environmental trends provide future pricing challenges or opportunities?