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Highlights from the Current IssueWinter 2011Cover Story How Will Biologics Fit Into Healthcare Reform?With so many variables, it’s hard to predict what kind of market will exist for biologics and other specialty drugs in 2014. Current trends may provide some insight. Renewing HumansRegenerative medicine is set for explosive growth. Proponents believe that advances in this field will forever change healthcare. Employers Struggle To Cope With the Rising Use of BiologicsTradeoffs in cost sharing or higher deductibles could derail treatment and decrease the value of healthcare spending. New Approaches to Treat Cancer – What They Can and Cannot Do
Nalân Utku, MD Gene Patent Reform: Still in DoubtThe patent-eligibility doctrine remains in limbo as the battle over
gene patents cuts a tortuous path to the high court. Leahy-Smith Act Sets a New FoundationThe new patent law gives biotechs an edge they have long wanted. DepartmentsOpeners The Business of Biologics
Katherine T. Adams Drug Track Clinical Trials, Research, and FDA Findings
Alan Caspi, PharmD, PhD, MBA The Federal Line Talking to Different Audiences
John Carroll Personalized Medicine New Automated HER2 Test Promises Faster, More Accurate Testing
Bob Carlson, MHA Featured Supplements![]() Immunotherapy for Advanced Prostate Cancer: A Novel Treatment Option to Improve SurvivalProstate cancer is the second leading cause of cancer death in men in the United States. Sipuleucel-T (Provenge), the first autologous cellular immunotherapy approved by the U. S. Food and Drug Administration, improves survival in men with asymptomatic or minimally symptomatic metastatic castration-resistant (hormone refractory) prostate cancer. This Clinical Brief discusses the epidemiology, natural history, and risk factors for prostate cancer, current diagnosis and treatment modalities, and the emergence of immunotherapy as a novel treatment to improve survival in men with advanced disease. Roger Muller, MD, FACEP, comments on managed care considerations. Safety information and full prescribing information for Sipuleucel-T are also provided.![]() Comparative Effectiveness Research: Paving the Way for Evidence-Based Decision MakingThe second in a series of topics of interest for the managed care community, this brief details the background of comparative effectiveness research (CER) in the United States and discusses the goals versus the uses of CER and the importance of collecting real-world data to support evidence-based medicine. Included are examples of the effective use of CER in clinical practice.![]() Personalized Medicine: Identifying the Appropriate Patient through Biomarkers in OncologyThe first in a series of topics of interest for the managed care community, this brief discusses the value of biomarkers that can complement or replace existing screening tools to detect cancer at an early stage and, therefore, guide optimum treatment. A history of biomarkers is included as well as a detailed discussion about trastuzumab (Herceptin®), developed with the support of biomarkers, and new biomarkers in development. |
Latest Biotechnology NewsRegister here to receive weekly biotechnology email updatesInlyta Approved to Treat Patients with Advanced Kidney Cancer 01/31/12 – The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. FDA Approves Vismodegib for Basal Cell Carcinoma 01/31/12 – The FDA has approved Erivedge (vismodegib) for the treatment of basal cell carcinoma, the most common type of skin cancer. Genetic Mutation Tied to Inherited Prostate Cancer 01/17/12 – Scientists say they've identified the first genetic mutation with a major effect on the risk of prostate cancer that runs in families and strikes men early, by age 55. Herceptin-Tykerb Combo Nearly Twice as Effective as Single-Drug Therapy 01/17/12 – Combining GlaxoSmithKline’s Tykerb drug with Roche Holding AG’s Herceptin to treat breast cancer was almost twice as effective as single-drug therapy, according to researchers in a 23-country clinical trial. First Patient Enrolled for Phase 3 Trial of Biosimilar Erythropoietin 01/10/12 – Hospira, Inc., announced enrollment of the first patient in a Phase 3 U.S. clinical program for its biosimilar erythropoietin (EPO). The study will compare safety and efficacy of Hospira's EPO and the reference product, Amgen's Epogen, in patients with renal (kidney) dysfunction who have anemia. |