News

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis based on positive findings from multiple Phase III trials.

Andrew Mackinnon, Executive GM, Medable, explains how the company’s recent approval in France could support the expansion of digital and decentralized clinical trials across Europe, particularly through enhanced e-consent practices.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, talks traditional research methods in clinical trials and why industry leaders remain reliant on them.

Survey from the Site Council gathered insights from its members on the quality of site coordinator work.

Phase III VERITAC-2 trial results show vepdegestrant significantly improved progression-free survivalcompared to fulvestrant in patients with ESR1-mutant (ESR1m) advanced or metastatic breast cancer, but did not achieve statistical significance in the overall intent-to-treat population.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the industry's willingness to adopt technology.

Understanding the benefits and concerns associated with implementing datasets into clinical trial workflows.

Phase III IMvoke010 trial found that maintenance treatment with Tecentriq (atezolizumab) did not significantly improve survival compared with placebo in patients with locally advanced squamous cell carcinoma of the head and neck following multimodal definitive treatment.

Andrew Mackinnon, executive GM, Medable, explains how the company ensures high patient participation and data accuracy in decentralized trials.

COVID-19 not only advanced scientific boundaries, but also transformed research methodologies and accelerated adaptive clinical trial design.

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

The pivotal Phase III study in myasthenia gravis met its primary endpoint with meaningful improvements in MG-ADL across both higher and lower dose arms.

Phase III DIPPER trial shows that adjuvant camrelizumab administered after induction-concurrent chemoradiotherapy significantly improved event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma, along with a favorable safety profile.

In this video interview, Cameron Breze, product manager, Inovalon, discusses the need for accurate information in creating useful clinical data.

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.

FDA grants Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for the treatment of moderate-to-severe Sjögren’s disease, which could be the first FcRn blocker ever approved for the autoimmune condition.

In this video interview, Cameron Breze, product manager, Inovalon, talks clinical technology and how the industry is working to increase comfortability with its implementation.

New data from the Phase II RAINFOL-01 study shows rinatabart sesutecan (Rina-S), an investigative antibody-drug conjugate, demonstrated a confirmed objective response rate of 55.6%.

In this video interview, Cameron Breze, product manager, Inovalon, discusses current challenges with patient recruitment and how a combination of technology and manual effort can help improve efficiency.

In the Phase III MIRASOL trial, Elahere (mirvetuximab soravtansine-gynx) significantly improved progression-free survival and overall survival compared to chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer.

Addressing data integrity and compliance concerns.

The BRAVE-AA-PEDS trial found that once-daily baricitinib significantly improved hair regrowth on the scalp, eyebrows, and eyelashes in adolescents with severe alopecia areata after 36 weeks, with faster response rates compared to adults.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how newly emerging data from patients can help the industry improve its recruitment strategies.

The combination demonstrated non-inferiority to comparator antiretroviral therapies, meeting the primary efficacy success criterion in both trials.

Phase I trial results show the potential of once-yearly lenacapavir as a long-acting PrEP option for HIV, supporting further clinical development in a more diverse population.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, talk technology and how it can save time in the recruitment process.

Icotrokinra met all primary endpoints in the studies, demonstrating significant skin clearance and clinical remission.

A meta-analysis of 11 trials shows that Padcev (enfortumab vedotin-ejfv), both alone and in combination with Keytruda (pembrolizumab), significantly improves response rates and survival outcomes compared to conventional chemotherapy in metastatic urothelial carcinoma.