Highlights from the Current Issue

Cover Story

Biologic Vaccines: A Panacea for Infectious Diseases?

The threat of new disease pandemics has spurred the development of biologic vaccines, which promise tremendous improvements in global and local health. Several lend themselves to the prevention or treatment of chronic diseases. But the uncertainties of whom to vaccinate raise the question of whether the health care system can make these promising products viable.
Katherine T. Adams

Controlling the Cost of Care through Clinical Pathways

A look at how two health plans have integrated physician-developed clinical pathways into their networks.
Bob Carlson

The Future of Biologics, Part I: Opportunity, Resources, and Affordability: Multistakeholder Perspectives

On two occasions last year, the Jefferson School of Population Health convened a National Advisory Board of scientists and opinion leaders from key stakeholder groups at a high-level forum to explore different perspectives and to discuss improving access for patients who require treatment with biologic drugs. The following is the first of two articles documenting these discussions. The second article will appear in a subsequent issue of Biotechnology Healthcare.
Janice l. Clarke, RN, BBA; Alexis Skoufalos, EdD; David B. Nash, MD, MBA; Eric Toppy

Payers Tightening Management of Specialty Therapies

Continued market growth among specialty therapies has attracted the attention of big pharma and investors. Many payers, however, believe the industry has reached a tipping point, where greater management focus — and tougher decisions — are needed.
Kirk McConnell and Melinda C. Haren, RN

Departments

Openers

The Loch Ness Vaccine

Michael D. Dalzell

Editorial

Playing Games

What Everquest teaches us about leadership.
David B. Nash, MD, MBA

Personalized Medicine

DTC Advertising: Where Do Genetic Tests Fit?

Is there a place for genetic tests in DTC ads?
Bob Carlson, MHA

Drug Track

Research, Conferences, and FDA Actions

Schuyler Matthews

Specialty Pharmacy

Cutting Back Expenses Through Carve-Outs

The crumbling economic environment may be an important catalyst for the heightened interest among employers in carving out specialty drugs.
Scott Kober

Employer to Employer

What’s Learned When the Health Plan Is the Employer

Sizing up a health plan’s health plan.
John Carroll

Biotechnology Healthcare’s 2008 Editorial Index

Trends: Consumer-Directed Plans

More Employees Turning to High-Deductible Health Plans

Amy Krajacic

Latest Biotechnology News

Cost-Effectiveness of Cancer Drugs Is Questioned

07/01/09 – The decision to use expensive cancer therapies that typically produce only a relatively short extension of survival is a serious ethical dilemma in the U.S. that needs to be addressed by the oncology community, according to a commentary published online June 29 in the Journal of the National Cancer Institute.

Phase 3 Trial of Migalastat Initiated

06/23/09 – Amicus Therapeutics announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, migalastat hydrochloride (Amigal) for the treatment of Fabry disease. The Company has reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. The Company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of this year.

Global Phase 3 Trial of BLP25, Treatment for Metastatic Breast Cancer, To Begin

06/23/09 – Oncothyreon Inc.announced that Merck KGaA of Darmstadt, Germany, has initiated a global Phase 3 trial of BLP25 liposome vaccine, L-BLP25 (Stimuvax) in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Stimuvax is an investigational therapeutic cancer vaccine.

Advisory Panel Recommends Approval of Pegloticase for the Treatment of Refractory Chronic Gout

06/23/09 – Savient Pharmaceuticals, Inc. announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a vote of 14 to 1 that pegloticase (Krystexxa), a biologic PEGylated uricase enzyme, be granted marketing approval by the FDA for the treatment of refractory chronic gout. Refractory chronic gout or treatment failure gout (TFG) is gout in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with conventional urate-lowering therapy at the maximum medically appropriate dose or for whom conventional urate-lowering therapy is contraindicated. The current target Prescription Drug User Fee (PDUFA) action date for the FDA's decision as to whether to grant marketing approval for the agent is August 1, 2009.

Ipilimumab Trial Results Demonstrate Cancer Cell Death and Significant Tumor Shrinkage

06/23/09 – Two Mayo Clinic patients whose prostate cancer had been considered inoperable are now cancer free thanks in part to an experimental drug therapy that was used in combination with standardized hormone treatment and radiation therapy. The men were participating in a clinical trial of an immunotherapeutic agent called MDX-010 or ipilimumab. In these two cases, physicians say the approach initiated the death of a majority of cancer cells and caused the tumors to shrink dramatically, allowing surgery. In both cases, the aggressive tumors had grown well beyond the prostate into the abdominal areas.