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Category: Clinical Trials


Clinical Trials, Research and Development

Accelerating Clinical Trials in the EU (ACT EU) initiative launch

January 14, 2022

Via: European Pharmaceutical Review

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) […]


Clinical Trials, Research and Development

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

January 12, 2022

Via: Biopharm International

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 […]


Clinical Trials, Research and Development

Medicare limits Aduhelm coverage to clinical trial participants

January 12, 2022

Via: Pharmaphorum

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 […]


Clinical Trials, Research and Development

Leveraging print and digital communications for patient-centric clinical trials

January 10, 2022

Via: Biopharma Dive

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 […]


Clinical Trials, Research and Development

10 clinical trials to watch in the first half of 2022

January 3, 2022

Via: Biopharma Dive

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 […]


Clinical Trials, Research and Development

2022 forecast: Pharma has the tools. Will clinical trials be less white in 2022?

December 22, 2021

Via: FierceBiotech

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 […]


Clinical Trials, Research and Development

Digital transformation will improve clinical trial process, say experts

December 17, 2021

Via: European Pharmaceutical Review

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 […]


Clinical Trials, Research and Development

Sotio Biotech, MSD Enter Clinical Trial Collaboration & Supply Agreement

December 8, 2021

Via: Contract Pharma

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 […]


Clinical Trials, Research and Development

Merck pauses 2 more trials of backbone HIV drug over red flag, raising doubts about multipronged R&D strategy

December 7, 2021

Via: FierceBiotech

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 […]


Clinical Trials, Research and Development

Early Epinephrine Therapy Leads to Better Cardiac Arrest Recovery

November 9, 2021

Via: Genetic Engineering and Biotechnology News

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 […]


Clinical Trials, Research and Development

Clinical trials face increasing challenges

November 8, 2021

Via: Biopharma Dive

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 […]


Clinical Trials, Research and Development

Is there a faster way to build clinical trials?

November 4, 2021

Via: Pharmaphorum

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 […]