The Future of BYOD Adoption
In the third and final part of this video interview, Sam Liu, VP of marketing, Vivalink looks forward in the BYOD space and forecasts potential advancements for consumer devices.
Data From Phase III PALOMA-3 Study for NSCLC Presented at ASCO Show Five-Fold Reduction in Infusion-Related Reactions
Results showed non-inferior efficacy and pharmacokinetics for subcutaneous amivantamab combined with lazertinib compared to intravenous administration.
Tagrisso Shows Significant Improvement in Progression-Free Survival in EGFRm NSCLC in Phase III Trial
Tagrisso (osimertinib; AstraZeneca) reduced the risk of disease progression or death by 84% in patients with unresectable, stage III epidermal growth factor receptor-mutated (non-small cell lung cancer with tumors that harbor exon 19 deletions or exon 21 (L858R) mutations.
AI-Enabled Clinical Trials: A Multiomic Roadmap to Success
How artificial intelligence can aid in selecting patients, leveraging safety insights, and optimizing combination therapies.
Differentiating Consumer- and Medical-Grade Wearables
In part 2 of this video interview, Sam Liu, VP of marketing, Vivalink discusses the key differences between consumer- and medical-grade wearables and their uses in clinical settings.
Clinical Trial Data Presented at ASCO Show Efficacy of Opdivo-Based Combinations Treating Lung Cancer
Results of the Phase III CheckMate -77T, CheckMate -816, and CheckMate -9LA trials show the potential of Opdivo to improve survival among patients with early and advanced stages of lung cancer.
ConcertAI Introduces New Artificial Intelligence Solutions Powered by Real-World Data at ASCO 2024
New solution, CARA AI, will aid in the exploration of real-world data and leverage workflows such as imaging and cohort generation.
Breyanzi Gets FDA Approval to Treat Relapsed/Refractory Mantle Cell Lymphoma
Approval of Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory mantle cell lymphoma was based on findings from the open-label, multicenter, pivotal TRANSCEND NHL 001 trial.
FDA Extends PDUFA Date for Dupixent in COPD, Requesting Additional Data From BOREAS and NOTUS Trials
Dupixent (dupilumab) was previously granted priority review status as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease.
Optimizing Technology Implementation to Improve Diversity in Clinical Research
Three key considerations for deploying technology to help increase diversity in trials.
Challenges With BYOD in Clinical Trials
In part 1 of this video interview, Sam Liu, VP of marketing, Vivalink touches on concerns with data accuracy and security in bring-your-own-device models.
Datopotamab Deruxtecan Achieves Superior Survival Compared to Chemo in Advanced Nonsquamous NSCLC
Patients with locally advanced or metastatic non-small cell lung cancer who were previously administered at least one line of therapy showed superior overall survival compared to docetaxel.
An Overview of FDA Diversity-Related Documents for Clinical Trials
There is significant potential in decentralized models and digital health technology to expand diversity in clinical trials.
Lexicon Pharmaceuticals Selects Medidata to Aid in Advancing Phase IIb Trial of Non-Opioid Drug for Neuropathic Pain
Lexicon will utilize Medidata’s decentralized clinical trial solutions to accelerate study of LX9211 in diabetic peripheral neuropathic pain.
FDA Grants Priority Review to Sarclisa Combo for Patients with Newly Diagnosed Multiple Myeloma Based on IMROZ Trial Findings
Sarclisa (isatuximab-irfc) could become the first anti-CD38 therapy indicated in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for a transplant.
Phase II Triple Combo Trial of Osemitamab for Gastric/Gastroesophageal Adenocarcinoma Produces Encouraging Results
Results showed median progression-free survival reached 12.6 months in patients with CLDN18.2 high or medium expression, including in patients with PD-L1 CPS<5.
Navigating Robotic Process Automation, ICH E6(R3) Changes, and Outsourcing in Clinical Trials
Six trends to help guide trial master file strategy.
KEYNOTE-522 Trial Results Show Neoadjuvant Keytruda Plus Chemo Improves Overall Survival in Triple-Negative Breast Cancer
Keytruda (pembrolizumab; Merck) plus chemotherapy administered as neoadjuvant treatment and then as monotherapy postsurgery produced a statistically significant improvement in overall survival in patients with high-risk early-stage triple-negative breast cancer.
The Impact of Wearables in Clinical Research: Q&A with Jeremy Wyatt, CEO of ActiGraph
Wyatt discusses how these devices are changing patient monitoring in clinical trials.
Innovating Beyond the Lab: The Critical Role of Contracting in Research
Biotechs can successfully overcome bottlenecks in time-to-market for new drugs by embracing contracting innovations with the same passion applied to research breakthroughs.
Clario Partners With Emsere, Extends Ophthalmic Medical Imaging Capabilities
New collaboration offers end-to-end solution, supplying and training sites on ophthalmic medical imaging equipment.
Nimbus’ Phase 1/2 Trial for NDI-101150 Shows Promise in Treating Advanced Solid Tumors
Results of the trial found that monotherapy led to clinical benefit in 16.7% of patients, including complete and partial responses in renal cell carcinoma (RCC) patients.
Boehringer Ingelheim and OSE Immunotherapeutics Announce Expansion of Two Solid Tumor Programs
Expanded collaboration seeks to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases.
Sanofi’s Phase II Trial of Rilzabrutinib Shows Clinically Meaningful Reduction in Loss of Asthma Control
Study results showed a 36% and 25% reduction in loss of asthma control (LOAC) with high and low doses of rilzabrutinib.
Phastar and Beaconcure Announce Partnership, Enhance Data Review in Clinical Trials
New agreement leverages Beaconcure’s technology to streamline review processes.
Identifying Relevant Randomized Clinical Trial Questions for Hospitalized Children
Newly published consensus statement outlines RCT questions ranked according to importance and feasibility.
Edgewood Oncology Doses First Two Patients in Phase IIa Study for BTX-A51, a Potential Treatment for Metastatic Breast Cancer
BTX-A51 aims to address GATA3 mutations, which affect around 15% of breast cancer patients.
Prioritizing Patients: Strategies and eCOA Best Practices in Drug Development
A more user-centered design can allow increased flexibility in the development of eCOA platforms, driving better engagement and participation.
GSK Presents Positive Results from SWIFT-1 and SWIFT-2, Phase III Trials Evaluating Depemokimab in Adults and Adolescents with Severe Asthma
Results from both trials demonstrated a significant reduction in annual asthma exacerbations over 52 weeks.
US Pharma and Biotech Summit 2024: Evolving Clinical Research
ICON plc CEO Steve Cutler discussed how strategic partnerships are driving advancements in clinical trials.