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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1. Criterion 2.

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News from AACR 2024: Sunday’s highlights

Drug Discovery World

Aviv Regev, Head and Executive Vice President of Research and Early Development at Genentech, opened the session with a discussion of how advances in genomic sequencing are fostering the development of data-rich cell atlases and what that data could mean for new insights into cancer biology and novel therapeutics.

In-Vivo 52
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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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New analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirm robust efficacy and long-term prevention

The Pharma Data

Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset. In both PROVENT and Paraphernalia, AZD7442 was generally well permitted.

Trials 52
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Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19

The Pharma Data

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

Trials 52
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Vir awarded $1 billion multi-year BARDA influenza contract

pharmaphorum

The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.

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AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo.

Trials 52