Category: Clinical Trials

January 14, 2022

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform clinical trials within the European Union (EU). The Aim of Accelerating Clinical Trials in the EU (ACT EU) […]

January 12, 2022

In a highly unusual decision for a therapy approved by FDA, the Centers for Medicare and Medicaid Services (CMS) took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab). The CMS National Coverage Determination […]

January 12, 2022

Biogen and partner Eisai had been hoping for good news from the review of Aduhelm (aducanumab) by the Centre for Medicare and Medicaid Services (CMS), but the draft decision means broad coverage of the drug will have to wait for […]

January 10, 2022

One of the strongest trends in clinical trials is patient centricity, which is to say, making the patient experience as easy and accessible as possible. During the height of the COVID-19 pandemic, this became even more of a focus because […]

January 3, 2022

One year ago, the biotechnology sector was in the middle of a record run. The successful development of coronavirus vaccines and drugs had helped slow the pandemic and propelled investment into new companies going public at a historic rate. Biotech […]

December 22, 2021

The data are clear: White patients are taking up the majority of clinical trials. About 130 million Americans across various races are “being somewhat ignored, [or] deprioritized, in clinical trials” that support regulatory approval, said Yele Aluko, M.D., chief medical […]

December 17, 2021

A total 35 percent of healthcare professionals worldwide believe that digital transformation — involving the use of technologies such as artificial intelligence (AI), big data, cloud computing, application programming interfaces (API) and digital platforms — would improve both pre-clinical and […]

December 8, 2021

Sotio Biotech, a clinical stage immuno-oncology company owned by PPF Group, has entered into a clinical trial collaboration and Supply Agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., through its subsidiaries, to evaluate the combination of […]

December 7, 2021

Are the foundations of Merck’s broad HIV development program crumbling? Having already paused combination work in response to a red flag, Merck has now temporarily stopped enrollment in phase 3 studies that are testing the backbone of its HIV strategy […]

November 9, 2021

Earlier epinephrine treatment during a cardiac arrest is linked to better recovery compared to later treatment, according to preliminary research to be presented at the American Heart Association’s Resuscitation Science Symposium (ReSS) 2021. The virtual meeting will be held November […]

November 8, 2021

The COVID-19 pandemic emerged at a time when the clinical trial landscape had reached a peak in complexity. Global trials are now commonplace as drug makers seek to establish efficacy in diverse populations. Many of the therapies in clinical studies […]

November 4, 2021

As you know, clinical trials can be complex. Industry standards are now required for clinical trial submission. This means even more associated costs, resources, time, and effort. The Formedix ryze clinical metadata repository (MDR) can help! So what can it […]