Highlights from the Current Issue

Cover Story

Managing The Immunomodulators

Dosage and indication "creep" with the new biologics to treat inflammatory diseases have payers enforcing strict utilization policies. Physicians counter that payers can’t dictate treatment. With even more biologics on the horizon, and drug spend spiralling upward, both sides need to seek a middle ground. The question is how?
John Carroll

The Value of Observational Cohort Studies for Cancer Drugs

Randomized controlled trials — the gold standard for clinical drug evaluation — can't always predict adverse events in real-world settings. For the new cancer therapies, observational cohort studies (OCSs) can help evaluate their effects in broader populations and provide valuable information for future clinical trials.
David R. Spigel, MD

Medical Devices: Adapting to the Comparative Effectiveness Landscape

Outcomes research for medical devices has always lagged, with good reason. Comparative effectiveness initiatives, though, will soon spur demand for more and better data, and that means more and better outcomes research training.
Anita Mohandas, MSc, and Kathleen A. Foley, PhD

Departments

Openers

Of Risks and Dreams

Michael D. Dalzell

Editorial

Entry and Exit

David B. Nash, MD, MBA

Personalized Medicine

Surprise District Court Ruling Invalidates Myriad Genetics’ BRCA Patents, But Appeal is Pending

Myriad Genetics’ BRCA patents ruling.
Bob Carlson, MHA

Drug Track

Clinical Trials, Research, and FDA Actions

Amy Krajacic

Specialty Pharmacy

Diagnostics Come of Age

An avalanche of new molecular diagnostics is on the way.
John Carroll

Trends

With Injectable Biologic Therapies on the Rise, Payers Face Tough Reimbursement Issues

The rise of injectable biologics poses tough reimbursement issues for payers.
Katherine T. Adams

Latest Biotechnology News

FDA Recommends Dropping Low Blood Pressure Drug Midodrine Hydrochloride

08/17/10 – The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

Lilly Halts Development of Semagacestat, Potential Treatment for Alzheimer's Disease

08/17/10 – Eli Lilly and Company will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.

Positive Results Announced for Phase 2 Trial of NOV-002 in Stage 2 Breast Cancer Patients

07/13/10 – Novelos Therapeutics, Inc. announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. Alberto Montero, MD, Assistant Professor of Medicine at the Miller School and medical oncologist at Sylvester, is the Principal Investigator.

Phase 3 Meeting Scheduled With US FDA Following Positive Results of Bone Marrow Regeneration Trial

07/13/10 – Australian regenerative medicine company, Mesoblast Limited, announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration (FDA) to discuss a proposed Phase 3 clinical trial program.

CVS Caremark, Generation Health Select 13 Drugs for PGx Alliance

06/02/10 – CVS Caremark and Generation Health announced the 13 drug therapies that will be included in the initial offering of their integrated Genetic Benefit Management service. The firms said that they are offering the industry's first Best Test Genetics Network, which coordinates pharmacogenomic testing for members of CVS Caremark's network.