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How biopharmas are advancing their pharmacovigilance operations.

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

In this video interview, Dipanwita Das, CEO & co-founder at Sorcero, discusses challenges such as high costs and long timelines in executing clinical trials.

Phase III HELIOS-B trial found that Amvuttra (vutrisiran) also preserved functional capacity and quality of life in patients with transthyretin amyloidosis with cardiomyopathy.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, discusses how EDC and EHR data can be streamlined to increase efficiency at sites.

In the study, Calquence plus chemotherapy reduced the risk of disease progression or death by 27%.

Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability profile, further establishing its efficacy in obesity treatment.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, highlights how data standards are empowering the use of artificial intelligence.

In the pivotal trial, patients treated with Omvoh experienced significant improvements in clinical remission and endoscopic response at one year.

An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, talks protocol submission formats and how data interoperability can support artificial intelligence.

A focus on data and process excellence advances product development.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, discusses historical challenges with long protocol development timelines and how they can be addressed.

Pilot trial shows that a user-friendly electronic patient-reported outcome (ePRO) monitoring system significantly improves patient-centered cardiovascular care by enhancing patient-physician communication, increasing clarity in treatment explanations, and empowering patients with better knowledge of their conditions.

Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.

Recent research from the Tufts CSDD gauged progress in the context of the “Chief Diversity Officer” role at top pharmaceutical companies.

Results from the TROPION-Lung05 and TROPION-Lung01 clinical trials show the promise of datopotamab deruxtecan, a novel TROP2-directed antibody-drug conjugate, for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

In this video interview, Sujay Jadhav, CEO of Verana Health, talks external control arms and how they can increase study feasibility and inclusivity.

While there has been a number of recent initiatives put into place to support diversity, equity, and inclusion in clinical trials, there is still a considerable amount of room for improvement.

The emerging solution helps assess how much a therapy being evaluated in a clinical trial can benefit an individual patient.

Phase III IRAKLIA trial shows that subcutaneous Sarclisa delivered via an on-body delivery system is as effective and safe as intravenous administration in treating relapsed or refractory multiple myeloma.

In this video interview, Sujay Jadhav, CEO of Verana Health, highlights the role of real-world evidence alongside unstructured and structured data in better understanding the patient journey.

In the study, nipocalimab plus standard of care demonstrated superiority in activities of daily living for patients with generalized myasthenia gravis.

A Phase Ib/II dose escalation and expansion trial shows promising antitumor activity and durable responses with Talvey (talquetamab) plus Tecvayli (teclistamab) in the treatment of relapsed or refractory multiple myeloma, but a higher incidence of grade 3 or 4 infections.

In this video interview, Sujay Jadhav, CEO of Verana Health, discusses how using genomic data and real-world evidence can provide added context to traditional factors such as Gleason scores and PSA levels.

Initial data from Phase I clinical trial showed encouraging single agent activity in patients with different types of PD-1 resistant tumors.

Study finds the typical cost of clinical research for developing new drugs is lower than previously estimated, with median costs providing a more accurate reflection than mean costs.

In this video interview, Sujay Jadhav, CEO of Verana Health, talks AI and its role in optimizing trial design.

Unlocking the full potential of artificial intelligence requires these stakeholders to ensure their data are accessible and secure.