Requires
Flash Player 9
Version Test
Download Flash

Current Issue

Cover Story

Healthcare Reform: How the Candidates’ Positions Indirectly Affect Access to and Financing of High-Tech Therapies

Nobody is out on the hustings talking about cost-sharing or fair means of access to bio­logics. But a pipeline loaded with them may ultimately force the government to address fundamental cost issues in healthcare. How the candidates’ positions play into this.
Lola Butcher

Molecular Diagnostics

HER2 Tests: How Do We Choose?

Incorrect test results defining HER2 status are not uncommon. Getting it wrong leads to spending a fortune on treatment that won’t work or denying therapy to people whose lives could be spared by it.
Bob Carlson, MHA

Cost Management

Managing MS: Trends, Issues, and Perspectives

The nature of multiple sclerosis and its treatment differ from some other conditions that are treated with biologics, leading to opportunities that could help to close gaps in patient care.
Mari Edlin

Care Management

High-Tech, Simple Solutions For Improving Patient Care Management

Nonadherence is an incredibly complex and difficult-to-address problem. Several products designed to appeal to tech-savvy patients offer the promise of one simple solution.
Marshall Fleurant, MD

Cost-Effectiveness

Cost-Effectiveness: An Evolving Science

Overseas, government payers challenge biopharma companies to show evidence of cost-­effectivess. Collaboration there could provide a model for U.S. payers and manufacturers.
John Carroll

Latest Biotechnology News

Phase 3 Trial Evaluating Motesanib for First-Line Treatment of Advanced Non-Small Cell Lung Cancer Suspended

11/20/08 – The Takeda Oncology Company, a subsidiary of Takeda Pharmaceutical Company Limited announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been temporarily suspended following a planned safety data review of 600 patients by the study's independent Data Monitoring Committee (DMC). Motesanib is part of a broad co-development program between Amgen and Takeda.

Patient Enrollment Completed for Phase 3 Trial of Erythropoiesis Stimulating Agent

11/18/08 – Affymax, Inc. announced that enrollment has been completed in the remaining phase 3 clinical trial of its lead investigational therapy, Hematide, which is being evaluated for the treatment of anemia in chronic renal failure patients. EMERALD 2 is fully enrolled with over 800 dialysis patients, collectively, from over 90 sites in the United States and Europe. The Hematide Phase 3 program, involving a total of approximately 2,600 chronic renal failure patients, consists of four open-label, randomized controlled clinical trials in the U.S. and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis. The trials in non-dialysis patients, called PEARL 1 and PEARL 2, are evaluating the safety and efficacy of Hematide compared to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time.

Pulmonary Arterial Hypertension Drug Fails to Improve Walking Distance in FREEDOM-C Trial

11/18/08 – United Therapeutics Corporation announced the results of the FREEDOM-C trial of oral treprostinil, a sustained-release formulation of treprostinil, in pulmonary arterial hypertension (PAH). Preliminary analysis demonstrates that the trial did not achieve statistical significance for the primary endpoint, six minute walk (6MW) distance at Week 16. The FREEDOM-C trial was a randomized, double-blind, placebo-controlled trial of patients with severe PAH, a chronic, life-threatening illness. The study population consisted of 354 patients who were optimized on an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or both.

Healthcare Provider Alert Issued for Efalizumab After Second Patient Develops Progressive Multifocal Leukoencephalopathy

11/18/08 – Genentech, Inc. announced that the company has issued a Dear Healthcare Provider letter to inform dermatologists and neurologists of a 2nd case of progressive multifocal leukoencephalopathy (PML) which resulted in the death of a 73-year old woman who had received efalizumab (Raptiva) for approximately four years for treatment of chronic plaque psoriasis. Based on the medical information available for the two cases of PML, which occurred in one 70-year old patient and one 73-year old patient who received Raptiva for approximately four years, Genentech believes that Raptiva likely increases the risk of PML and that prolonged exposure to Raptiva and older age may further increase this risk. The company is working with the U.S. Food and Drug Administration (FDA) to determine the appropriate next steps.

Cinryze Study Demonstrates Improvement in Symptoms 30 Minutes Post Treatment

11/12/08 – ViroPharma Incorporated announced the presentation of data from its ongoing, open-label study, showing that in this study Cinryze(TM) C1 inhibitor therapy successfully treated all types of acute hereditary angioedema (HAE) attacks seen in the study through the date of analysis. Patients suffering acute attacks of HAE who were treated with Cinryze experienced improvement in symptoms at a median time of 30 minutes post treatment. None of the subjects in this study treated for laryngeal attacks required hospitalization or intubation. The findings were presented today at the American College of Allergy, Asthma and Immunology (ACAAI) 2008 Annual Meeting in Seattle, WA.