DEA Greenlights Epidiolex Launch with Drug Schedule Reclassification

Earlier this year, we wrote that GW Pharmaceuticals was poised to receive the first approval from the U.S. Food and Drug Administration (FDA) for a drug derived from the cannabis plant — Epidiolex (cannabidiol, also known as CBD), a treatment… Read »

First RNAi Drug Hits the Market — At a Very High Price

On August 13, the U.S. Food and Drug Administration (FDA) approved Alnylam’s Onpattro (patisiran), rapidly followed by that product’s approval in Europe three weeks later.  Onpattro, which we previously wrote about, is the first RNAi-based treatment to reach the marketplace…. Read »

Innovations in Electronic Health Records

Increasingly, hospital and health systems have moved from paper charts to electronic health records (EHRs). EHRs offer ways to streamline clinical workflows, reduce medical errors and increase patient safety, and provide stronger support for clinical decision-making. However, linking such records… Read »

Gene Therapy Update Part 2

Last week we wrote about recent news in the field of CRISPR/Cas9 research. But CRISPR is not the only approach to gene editing under development, nor the most advanced.   First Human Gene Editing Data — But Not from CRISPR… Read »

Gene Therapy Update Part 1: Big Advances and Big Questions for CRISPR

The gene therapy field has seen several developments in recent months, especially around CRISPR, with both significant achievements and further controversies about the safety of the gene editing approach.   CRISPR Cure for Duchenne’s Muscular Dystrophy (DMD) in Dogs  … Read »

Seminal Immuno-oncology Discoveries Honored by 2018 Nobel Prize

Seemingly spontaneous remissions from terminal cancers are known to occur on rare occasions.  For over 100 years, this observation has spurred scientists to attempt to engage the immune system to fight cancer, with little success. But on October 1, the… Read »

The Growing Influence of ICER

We have previously written about the Institute for Clinical and Economic Review (ICER), the independent watchdog whose mission is to offer an objective evaluation of the clinical and economic value of prescription drugs, medical tests, and other healthcare innovations.  … Read »

U.S. Drug Spending: Where the Money Goes

Two recently published analyses are providing a more in-depth picture of prescription drug spending in the United States. Such evaluations illustrate the complexities facing policy makers and regulators seeking to help reduce patient and payer drug costs. In addition, they… Read »

FDA Issues Set of Guidelines on Gene Therapy

Back in December, the U.S. Food and Drug Administration (FDA) granted its first approval for a gene therapy product, Spark Therapeutics’ Luxturna. According to the Alliance for Regenerative Medicine, as many as 50 more such treatments — addressing a diverse… Read »

As Brexit Approaches, Concerns about Impacts Abound

On March 29, 2019, the United Kingdom is scheduled to leave the European Union (EU). Since the UK passed the referendum in 2016 to leave the economic bloc, there have been plenty of uncertainties on how this will affect not… Read »

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