Current Issue

Cover Story

Cancer Vaccines: A Century in the Making... Almost Here?

Cancer immunotherapeutics, including vaccines, may hit the market by the end of this decade. They promise longer survival and perhaps indefinite remission at a more favorable cost-benefit ratio than that of oncologics now in use. They also may fuel dramatic changes in how healthcare is delivered and financed.
Katherine T. Adams

Business

Convergence in the Midst of Competition

As biotechs hit their adolescence, they — like test makers and pharmaceutical manufacturers — are more likely than ever to reach outside of their own areas of expertise, link hands with the other guys, and pursue new programs and technologies.
John Carroll

Policy

Biopharmaceuticals: The Economic Equation

As more biopharmaceuticals reach the market, more attention will be given to issues such as cost-effectiveness evaluations, biosimilars, and price controls. The value ­biologic therapies bring to the healthcare system may take years to ­appreciate in full — perhaps only when policy decisions allow for their economic effects to be understood.
Erwin A. Blackstone, PhD, and Joseph P. Fuhr Jr., PhD

Diagnostics

A Wish List for Molecular Tests

Companion diagnostics improve health outcomes, say developers, who are willing to work with payers to develop medical policies for coverage. Payers and clinicians want more evidence of long-term benefit. The FDA, meanwhile, is jostling for regulatory control. How long will patients have to wait? Part 2 of 2
Bob Carlson, MHA

Regulatory

Lower Cost and Faster Product Approval Through Proper Software Design Controls

The market success of a medical device depends in large part on how well its software is programmed. Focusing heavily on the device while treating the software as an afterthought can lead to costly recalls and liability concerns.
Kevin Stevens and Anthony Johnson

Latest Biotechnology News

Palifosfamide Receives Orphan Drug Status in the Treatment of Soft Tissue Sarcoma

05/09/08 – Ziopharm Oncology, Inc. announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to palifosfamide in the treatment of Soft Tissue Sarcoma (STS). The United States Orphan Drug Act of 1983 was created to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States.

Phase 3 Study Shows That Tocilizumab Can Inhibit Progression of Joint Damage in Rheumatoid Arthritis

05/09/08 – Roche today announced one-year results from a new two-year phase 3 study showing that tocilizumab (Actemra) can significantly inhibit progression of structural damage to joints in patients with rheumatoid arthritis (RA), a critical measure of effectiveness of an RA treatment. The study also demonstrated that ACTEMRA reduces disease signs and symptoms at one year. The LITHE study is the fifth international phase 3 Actemra trial to successfully meet its primary endpoints in patients with moderate to severe RA.

Higher Immune Response Seen in Menveo Vaccine Compared to Menactra

05/06/08 – New phase 3 data for MenACWY-CRM (Menveo) show that the vaccine produced a greater immune response against meningococcal serogroups A, C, W-135 and Y in adolescents 11-18 years of age compared to Menactra. Infection with any of these four vaccine-preventable serogroups can lead to bacterial meningitis, an infection of the membrane around the brain and spinal cord, or sepsis, a serious infection of the blood stream.

Phase 4 Study Initiated for Ambrisentan

05/06/08 – Gilead Sciences, Inc. announced the initiation of ATHENA-1, a phase 4, randomized, double-blind, placebo-controlled study evaluating ambrisentan (Letairis) in patients with pulmonary arterial hypertension (PAH) demonstrating a sub-optimal response to sildenafil monotherapy. ATHENA-1 is the first of several phase 4 Letairis studies Gilead plans to initiate in 2008 and 2009. Letairis is currently approved as a once-daily treatment for PAH (WHO Group 1) in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening.

Advisory Committee Recommends Approval of C1 Inhibitor for Hereditary Angioedema

05/06/08 – Lev Pharmaceuticals, Inc. announced that the Blood Products Advisory Committee to the Food and Drug Administration (FDA) today voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of C1 inhibitor (Cinryze) for the prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency.