Highlights from the Current Issue

Cover 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.
Michael D. Dalzell

Renewing Humans

Regenerative medicine is set for explosive growth. Proponents believe that advances in this field will forever change healthcare.
Bob Carlson, MHA

Employers Struggle To Cope With the Rising Use of Biologics

Tradeoffs in cost sharing or higher deductibles could derail treatment and decrease the value of healthcare spending.
Lola Butcher

New Approaches to Treat Cancer – What They Can and Cannot Do

Nalân Utku, MD

Gene Patent Reform: Still in Doubt

The patent-eligibility doctrine remains in limbo as the battle over gene patents cuts a tortuous path to the high court.
Joanna T. Brougher, JD, MPH

Leahy-Smith Act Sets a New Foundation

The new patent law gives biotechs an edge they have long wanted.
Stephen Barlas

Departments

Openers

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 Survival

Prostate 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 Making

The 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 Oncology

The 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 News

Inlyta 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.