News

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high U.S. revenues to fund biopharmaceutical R&D. Payers and insurers have become more aggressive in demanding clear evidence of value for high-priced medicines and are rejecting old models for coverage and reimbursement.

In early January, Novartis selected Qualcomm Life as a global digital health collaborator for its Trials of The Future program. That program is designed to leverage healthcare technology to improve the experience of clinical trial participants and patients using Novartis products.

Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences, today announced a strategic collaboration with Garmin International Inc.

ClinPlan provides automated, efficient, and accurate way to assess and reassess trial expenses over time throughout the life of the trial.

Clinverse, Inc., provider of automated financial management technology solutions for clinical trials, announced today that it has expanded its suite of products with the addition of ClinPlan™, purpose-built software for clinical trial budget management and forecasting.

Peer Review Article

Astellas Pharma Inc. (Tokyo: 4503, "Astellas") announced today that the company will now make trial data available through www.clinicalstudydatarequest.com,

ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced it has agreed, subject to certain customary closing conditions, to acquire MediMedia Pharma Solutions for a cash consideration of $120 million.

ERT, a leading provider of technology solutions and services that increase the reliability and efficiency of high-quality patient data collection, today announced that its electronic Suicide Risk Assessment (SRA) system – AVERT® – will be implemented by Rutgers University

The "discussion draft" for legislation to speed "21st Century Cures" to patients emerged very quietly on Capitol Hill recently, muted by an absence of bipartisan support which had generated considerable enthusiasm for this effort to promote biomedical research and streamline regulation.

Efforts are escalating to encourage sponsors, research institutions, and clinical investigators to accept oversight for multi-center studies by central institutional review boards (IRBs), as seen in several discussions of this topic at the December conference on "Advancing Ethical Research" sponsored by Public Responsibility in Medicine & Research.

In early January, Novartis selected Qualcomm Life as a global digital health collaborator for its Trials of The Future program.

The World Health Report 2013 argues that universal health coverage cannot be achieved without the evidence from scientific research, and in order to better manage healthcare, clinical research needs to keep up-to-date and advance in line with society in general.

A surge in review activity at the FDA in December resulted in a near-record approval of 41 new drugs and biologics last year, the most since a record 56 approvals in 1996.

Agency proposes new standards in hopes of capitalizing on 2014 surge in new drug approvals.

The five-year figure doesn't always determine which cancer types are most commonly being studied in late-phase trials.

Sites: Integrated Clinical Research Boosting the Investigator Pool Trial Design: Remote Patient-Centered Studies Risk-Based Monitoring in Action Also in this issue: New Drug Approval Momentum mHealth in Clinical Trials Simplifying Protocol Design

The developed markets of North America and Europe together saw approximately 81% of the Phase I trial share in 2013 which is a 6% increase from 2012. Trials

The Clinical Trials Transformation Initiative (CTTI) has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials.

The idea is great: when an investigator submits a grant to any NIH institute, if the study will involve more that one performance site, the grant must include a plan to rely on one single IRB.

One way to reduce off-label prescribing of treatments for cancer and other conditions is for manufacturers to test additional indications and file supplemental applications to add those uses to approved labeling