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An Examination Of California's Proposed Budget Cuts
The New York Times reports on a series of deep budget cuts to help California, which is some $24 billion in the red, deal with its" ongoing financial woes.
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Nexavar® In Combination With Chemotherapy Shown To Extend Progression-Free Survival In Patients With Advanced Breast Cancer
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. announced that their first cooperative group-sponsored randomized Phase II trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar® (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant (p-value = 0.0006). In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting.
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Cohesin Jigsaw Begins To Fit
The essential chromosomal protein complex cohesin has crucial roles in sister chromatid cohesion, DNA repair and transcriptional regulation. Despite its conserved function, cohesin"s disparate association patterns in different organisms did not quite add up. New research published in the open access journal Genome Biology works towards completing the cohesin puzzle, reconciling some of these differences.
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BIO Testifies On Importance Of Data Exclusivity And Patent Protection In Pathway For Approval Of Biosimilars

The Biotechnology Industry Organization (BIO) testified yesterday before the House Judiciary Subcommittee on Courts and Competition Policy on "Biologics and Biosimilars: Balancing Incentives for Innovation." "We thank the Subcommittee for holding a hearing on the critical topic of balancing incentives for innovation in a biosimilars pathway. BIO continues to strongly support a pathway for the approval of biosimilars which protects patient safety and preserves incentives for continued innovation," BIO President and CEO Jim Greenwood stated. "We look forward to continuing discussions in the House and Senate as they consider this issue in the context of health care reform." In his testimony on behalf of BIO, Jeffrey P. Kushan of Sidley Austin LLP stressed the importance of including significant data exclusivity in any pathway for the approval of biosimilars and the need to provide a fair and balanced system to resolve patent disputes before a biosimilar is approved and marketed. "By allowing the biosimilar manufacturer to "free-ride" on the clinical data of the innovator, the abbreviated pathway helps the biosimilar manufacturer bring its product to market faster, with far less risk and uncertainty, and at a fraction of the innovator"s development costs. Unquestionably, the business of biotechnology innovation will change once an abbreviated pathway for biosimilar products becomes available," stated Kushan. "And patent rights, as they exist in today"s system, simply will not be sufficient to preserve the incentives for development of new biological products and treatments that exist in today"s industry." "Measures that offset the impact of these fundamental changes to the nature of competition in today"s biotechnology industry must be integrated into any new regulatory approval system for biosimilar products," Kushan stressed. "Measures that operate to lessen the economic incentives of our current system will translate into fewer new biological products and therapies, to the detriment of patients with currently unmet medical needs." Kushan also rebutted the recent report by the Federal Trade Commission (FTC) by pointing out that the report"s conclusions are not supported by evidence. He explained how the FTC incorrectly portrayed the nature and effects of competition between biosimilar and innovator companies, incorrectly described the capacity of patent rights alone to encourage initial and ongoing clinical research in a biosimilar market, and incorrectly asserted that data exclusivity under Hatch-Waxman is provided only for unpatentable drugs. BIO"s testimony is available here. BIO


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