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Featured Studies & Reports
Continued Development of Approved Biological Drugs
7 December, 2007 - According to a new study by the Boston Consulting Group, to date, 47 percent of biologics regulated by FDA’s Center for Drug Evaluation and Research have at least one new FDA-approved indication after the initial approval. On average, a biologic that has been on the market for six years is expected to have two additional indications approved over the remainder of it lifetime.
Post-Approval Research on Biotech Medicines Leads to Key Medical Advances
31 October, 2007 - A new paper from the Pharmaceutical Research and Manufacturers of America (PhRMA) about post-approval research on biologics explores how new indications are developed and approved and through several examples illustrates (1) the range of additional indications approved by the FDA and (2) ongoing research into new indications.
Data Exclusivity for New Biological Entities
5 October, 2007 - A new working paper by Duke University economist Dr. Henry Grabowski, “Data Exclusivity for New Biological Entities,” identifies 12.9 to 16.2 years — or about 13 to 16 years — of data exclusivity as necessary to sustain investment in the research and development (R&D) of new biologics in any approach to creating an abbreviated pathway for FOBs.
Breast Cancer Patients Living Longer Thanks to New Medicines
21 September, 2007 - A recent study in the journal Cancer found that survival times for patients with metastatic breast cancer (MBC) improved by 30 percent between the early 1990s and the end of the decade. The researchers link the improvement to new medicines that became available in that period.
Cancer Survival Rates Higher in the U.S. than in Europe
21 September, 2007 - A recent study published in The Lancet Oncology found that survival rates for cancer patients in the United States are higher than in Europe. The study found that for all types of cancers, women in the U.S. had a 63 percent five-year relative survival rate compared to 56 percent in European women. Even more dramatic was that men in the U.S. had a 66 percent relative rate of survival for all types of cancer compared to only 47 percent in Europe.
Data Exclusivity Is Key to Maintaining Continued Innovation in Biologics
27 July, 2007 - A new paper from the Pharmaceutical Research and Manufacturers of America (PhRMA) was released in July about the importance of data exclusivity.
Study Shows Hypertension Treatment and Control Better in the United States than Western Europe
18 July, 2007 - A recent study published in the Archives of Internal Medicine found that lower treatment thresholds and more intensive treatment in the U.S. contributed to better blood pressure control than in western European countries.
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