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Category: Medicine

Epkinly Demonstrates Encouraging Efficacy in Phase II Trial for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Medicine

Epkinly Demonstrates Encouraging Efficacy in Phase II Trial for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

adminSeptember 5, 2025September 5, 2025

Image Credit: Adobe Stock Images/J lee Topline Findings Outpatient Treatment Potential: Epkinly may allow safe administration of relapsed or refractory…

2025 Veeva R&D and Quality Summit Clinical Opening Keynote
Medicine

2025 Veeva R&D and Quality Summit Clinical Opening Keynote

adminSeptember 4, 2025

Jim Reilly, president, Development Cloud, and EVP, global strategy, Veeva Image Credit: Andy Studna In the opening keynote of the…

Merck’s Oral PCSK9 Inhibitor Demonstrates Efficacy in Hypercholesterolemia
Medicine

Merck’s Oral PCSK9 Inhibitor Demonstrates Efficacy in Hypercholesterolemia

adminSeptember 4, 2025September 4, 2025

Image Credit: Adobe Stock Images/Olga Gorkun Topline Findings Oral PCSK9 Inhibitor Innovation: Enlicitide decanoate is the first oral macrocyclic peptide…

Roche, Alnylam Launch Phase III Trial for Novel RNAi Therapeutic in Uncontrolled Hypertension
Medicine

Roche, Alnylam Launch Phase III Trial for Novel RNAi Therapeutic in Uncontrolled Hypertension

adminSeptember 3, 2025September 3, 2025

Image Credit: Adobe Stock Images/wutzkoh Roche and Alnylam are launching the Phase III ZENITH cardiovascular outcomes trial (CVOT) to evaluate…

Merck’s Verquvo Fails to Meet Primary Endpoint in Phase III Trial for Chronic Heart Failure and Reduced Ejection Fraction
Medicine

Merck’s Verquvo Fails to Meet Primary Endpoint in Phase III Trial for Chronic Heart Failure and Reduced Ejection Fraction

adminSeptember 3, 2025

Image Credit: Adobe Stock Images/lovelyday12 Topline Findings Verquvo in chronic heart failure and reduced ejection fraction (HFrEF): Verquvo (vericiguat) continues…

Top Questions on Funding Cuts in Clinical Research
Medicine

Top Questions on Funding Cuts in Clinical Research

adminSeptember 2, 2025

© photon_photo – © photon_photo – stock.adobe.com What clinops professionals need to know Funding cuts in clinical research are tightening…

Supreme Court Ruling, VK2735 Obesity Trial, and Padcev-Keytruda Survival Gains
Medicine

Supreme Court Ruling, VK2735 Obesity Trial, and Padcev-Keytruda Survival Gains

adminSeptember 2, 2025September 2, 2025

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three…

Theravance Biopharma Completes Phase III CYPRESS Trial Enrollment for Novel Norepinephrine Reuptake Inhibitor in Multiple System Atrophy
Medicine

Theravance Biopharma Completes Phase III CYPRESS Trial Enrollment for Novel Norepinephrine Reuptake Inhibitor in Multiple System Atrophy

adminSeptember 1, 2025September 1, 2025

Image Credit: Adobe Stock Images/Fitry Topline Findings Phase III CYPRESS Enrollment Completed: Theravance Biopharma finishes open-label patient enrollment in the…

How Research Sites Balance Funding Cuts and Efficiency Pressures
Medicine

How Research Sites Balance Funding Cuts and Efficiency Pressures

adminSeptember 1, 2025

Lipset: Clearly, this is a very polarizing time politically for a lot of folks, but I think objectively, most would…

Evrysdi Helps Presymptomatic Infants with Spinal Muscular Atrophy Sit, Stand, and Walk in Phase II Trial
Medicine

Evrysdi Helps Presymptomatic Infants with Spinal Muscular Atrophy Sit, Stand, and Walk in Phase II Trial

adminAugust 31, 2025August 31, 2025

Credit: Dzmitry | stock.adobe.com Infants with spinal muscular atrophy (SMA) administered early treatment with Evrysdi (risdiplam) demonstrated motor milestone achievements that…

An Evidence-Based Framework for Assessing Site Selection Decisions
Medicine

An Evidence-Based Framework for Assessing Site Selection Decisions

adminAugust 31, 2025

Credit: photon_photo | stock.adobe.com Background Clinical trial success depends on selecting appropriate clinical sites. Poor site selection can lead to…

Why Clinical Trial Innovations Take Years to Gain Adoption
Medicine

Why Clinical Trial Innovations Take Years to Gain Adoption

adminAugust 30, 2025

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of…

Reimagining Clinical Trials for Remote Populations
Medicine

Reimagining Clinical Trials for Remote Populations

adminAugust 30, 2025August 30, 2025

Credit: kentoh | stock.adobe.com Decentralized clinic trials are more than a mere trend, they are a revolution in the ways…

Addressing the Digital Divide in Decentralized Trials
Medicine

Addressing the Digital Divide in Decentralized Trials

adminAugust 29, 2025

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of…

Navigating CGM and BGM Decisions in GLP-1 Clinical Trials
Medicine

Navigating CGM and BGM Decisions in GLP-1 Clinical Trials

adminAugust 29, 2025August 29, 2025

Credit: Proxima Studio | stock.adobe.com As GLP-1 therapies expand from diabetes into obesity, cardiovascular disease, and rare conditions, clinical trial…

FDA Authorizes New COVID Vaccines with Restrictions on Eligibility
Medicine

FDA Authorizes New COVID Vaccines with Restrictions on Eligibility

adminAugust 28, 2025

Image Credit: © JHVEPhoto – stock.adobe.com For individuals who fall outside of the conditions listed under the new CDC recommendations,…

Phase III NIMBLE Trial Demonstrates Cemdisiran Efficacy in Generalized Myasthenia Gravis
Medicine

Phase III NIMBLE Trial Demonstrates Cemdisiran Efficacy in Generalized Myasthenia Gravis

adminAugust 28, 2025

Image Credit: Adobe Stock Images/Robin What clinops professionals need to know The Phase III NIMBLE trial demonstrated that cemdisiran, given…

Why Decentralized Trials Face Slow Adoption Despite Strong Data
Medicine

Why Decentralized Trials Face Slow Adoption Despite Strong Data

adminAugust 27, 2025

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of…

Phase I/II RAINFOL-01 Trial Results Lead to FDA Breakthrough Designation for Genmab’s Rina-S for Advanced Endometrial Cancer
Medicine

Phase I/II RAINFOL-01 Trial Results Lead to FDA Breakthrough Designation for Genmab’s Rina-S for Advanced Endometrial Cancer

adminAugust 27, 2025

Image Credit: Adobe Stock Images/MKS The FDA has granted Breakthrough Therapy Designation (BTD) to Genmab’s Rina-S (rinatabart sesutecan) for the…

FDA Expands Transparency With Daily Adverse Event Reporting
Medicine

FDA Expands Transparency With Daily Adverse Event Reporting

adminAugust 26, 2025

Image Credit: © JHVEPhoto – stock.adobe.com What clinops professionals need to know The FDA will now publish FAERS adverse event…

Bias Starts Early in Research. So Can AI.
Medicine

Bias Starts Early in Research. So Can AI.

adminAugust 26, 2025

Image Credit: © Shuo – stock.adobe.com What clinops professionals need to know Early-stage research is vulnerable to bias due to…

How Flexible Site Models Can Cut Recruitment Costs and Timelines
Medicine

How Flexible Site Models Can Cut Recruitment Costs and Timelines

adminAugust 25, 2025

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network…

NCX 470 Meets Phase III Goal in Glaucoma With Strong Intraocular Pressure Reductions
Medicine

NCX 470 Meets Phase III Goal in Glaucoma With Strong Intraocular Pressure Reductions

adminAugust 25, 2025

Image Credit: © Pixel-Shot – stock.adobe.com Nicox has shared positive results from the Phase III Denali clinical trial (NCT04630808) evaluating…

Building Partnerships to Better Serve Underrepresented Trial Communities
Medicine

Building Partnerships to Better Serve Underrepresented Trial Communities

adminAugust 24, 2025

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network…

Supreme Court Upholds NIH Funding Cuts Affecting DEI in Clinical Research
Medicine

Supreme Court Upholds NIH Funding Cuts Affecting DEI in Clinical Research

adminAugust 24, 2025

Image Credit: © WESTOCK – stock.adobe.com What clinops professionals need to know Recent NIH funding cuts tied to DEI policies…

Dynavax Technologies’ Investigational Shingles Vaccine Achieves Complete Antibody Response in Phase I/II Shingles Trial
Medicine

Dynavax Technologies’ Investigational Shingles Vaccine Achieves Complete Antibody Response in Phase I/II Shingles Trial

adminAugust 23, 2025

Image Credit: Adobe Stock Images/Suriyawut Topline Findings Z-1018 Shingles Vaccine Shows Comparable Immunity: In part 1 of the Phase I/II…

DEI & Clinical Trials: Navigating Policy Shifts
Medicine

DEI & Clinical Trials: Navigating Policy Shifts

adminAugust 23, 2025August 23, 2025

This presentation was generated based on two articles written by Rebecca Johnson, PhD: The Impact of DEI Ban On Clinical…

Phase II Trial Launches of Anktiva in Long COVID Patients
Medicine

Phase II Trial Launches of Anktiva in Long COVID Patients

adminAugust 22, 2025August 22, 2025

Image Credit: © Production Perig – stock.adobe.com ImmunityBio has initiated a new Phase II study, COVID-4.019-Long (NCT07123727), to evaluate the…

Celldex Therapeutics’ Novel Humanized Monoclonal Antibody Falls Short in Phase II Trial Treating Eosinophilic Esophagitis
Medicine

Celldex Therapeutics’ Novel Humanized Monoclonal Antibody Falls Short in Phase II Trial Treating Eosinophilic Esophagitis

adminAugust 22, 2025

Image Credit: Adobe Stock Images/Ti Studio Topline Findings Primary Endpoint Not Met: Barzolvolimab did not improve eosinophilic esophagitis (EoE) symptoms,…

How Digital Twins and AI Are Reshaping Clinical Trials
Medicine

How Digital Twins and AI Are Reshaping Clinical Trials

adminAugust 21, 2025

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three…

FDA Lifts Clinical Hold on Rocket Pharmaceuticals’ Phase II Novel Investigative Gene Therapy Trial for Danon Disease
Medicine

FDA Lifts Clinical Hold on Rocket Pharmaceuticals’ Phase II Novel Investigative Gene Therapy Trial for Danon Disease

adminAugust 21, 2025

Image Credit: Adobe Stock Images/nature_photo by ice Topline Findings FDA lifts clinical hold on RP-A501 trial: Rocket Pharmaceuticals’ pivotal Phase…

How In-Home and Community Strategies Boost Recruitment and Diversity
Medicine

How In-Home and Community Strategies Boost Recruitment and Diversity

adminAugust 20, 2025

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network…

Phase II Trial Launches to Evaluate Hepzato in Liver-Dominant Colorectal Cancer
Medicine

Phase II Trial Launches to Evaluate Hepzato in Liver-Dominant Colorectal Cancer

adminAugust 20, 2025

Image Credit: © Dr_Microbe – stock.adobe.com What clinops professionals need to know The Phase II trial is evaluating Hepzato in…

The Reality of Operational Flexibility for Trial Sites
Medicine

The Reality of Operational Flexibility for Trial Sites

adminAugust 19, 2025

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network…

Phase II Trial Data Lead to FDA Breakthrough Therapy Designation for Ifinatamab Deruxtecan in Extensive-Stage Small Cell Lung Cancer
Medicine

Phase II Trial Data Lead to FDA Breakthrough Therapy Designation for Ifinatamab Deruxtecan in Extensive-Stage Small Cell Lung Cancer

adminAugust 19, 2025

Image Credit: Adobe Stock Images/Bartek Topline Findings FDA Breakthrough Therapy Designation (BTD): I-DXd (ifinatamab deruxtecan) receives FDA BTD for pretreated…

How AI Is Reshaping Clinical Operations and Study Feasibility
Medicine

How AI Is Reshaping Clinical Operations and Study Feasibility

adminAugust 18, 2025

Rohit Nambisan, CEO, Lokavant Jonathan Crowther, head of predictive analytics, Pfizer Summary AI adoption in clinical operations is accelerating, with…

Future-Proofing Trial Protocols to Avoid CRLs
Medicine

Future-Proofing Trial Protocols to Avoid CRLs

adminAugust 18, 2025

In a recent video interview with Applied Clinical Trials, Meri Beckwith, Co-CEO, Lindus Health, discussed the evolving perception of breakthrough…

The Critical Role of Clinical Ops Teams in Maintaining Clinical Trial Integrity
Medicine

The Critical Role of Clinical Ops Teams in Maintaining Clinical Trial Integrity

adminAugust 17, 2025

In a recent interview with Applied Clinical Trials, Ron Lanton, partner at Lanton Law, discussed the pivotal role clinical operations…

Embracing Proactive Multi-Indication Development for Metabolic Therapies
Medicine

Embracing Proactive Multi-Indication Development for Metabolic Therapies

adminAugust 17, 2025

Alan Baldridge, MD, Senior Director, Gastroenterology and Hepatology, Drug Development Solutions, ICON What clinops professionals need to know A 2025…

Apreo Health Launches Pivotal BREATHE-3 Trial for Severe Emphysema
Medicine

Apreo Health Launches Pivotal BREATHE-3 Trial for Severe Emphysema

adminAugust 16, 2025

Image Credit: Adobe Stock Images/Vii Topline Findings First Patient Treated: Apreo Health has enrolled the first patient in the pivotal…

Phase II Trial Demonstrates Vision Gains in Stargardt Disease With MCO-010
Medicine

Phase II Trial Demonstrates Vision Gains in Stargardt Disease With MCO-010

adminAugust 16, 2025

Image Credit: © Pixel-Shot – stock.adobe.com What clinops professionals need to know The Phase II STARLIGHT trial evaluated a single…

Phase II B-SUPREME Trial Launches for ALG-000184 in Chronic Hepatitis B
Medicine

Phase II B-SUPREME Trial Launches for ALG-000184 in Chronic Hepatitis B

adminAugust 15, 2025

Image credit: © Destina – stock.adobe.com What clinops professionals need to know The Phase II B-SUPREME trial is evaluating ALG-000184,…

Vedanta’s Microbiome-Based Candidate Fails to Meet Primary Endpoint in Phase II Trial for Mild-to-Moderate Ulcerative Colitis
Medicine

Vedanta’s Microbiome-Based Candidate Fails to Meet Primary Endpoint in Phase II Trial for Mild-to-Moderate Ulcerative Colitis

adminAugust 15, 2025

Image Credit: Adobe Stock Images/Sean Topline Findings VE202 Phase II Results: Vedanta Biosciences’ VE202 did not meet the trial’s primary…

Breaking Down Data Silos to Accelerate Clinical Trials
Medicine

Breaking Down Data Silos to Accelerate Clinical Trials

adminAugust 14, 2025

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three…

Enhancing Clinical Trial Integrity Through AI and Digital Twin Technologies
Medicine

Enhancing Clinical Trial Integrity Through AI and Digital Twin Technologies

adminAugust 14, 2025

In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed…

Phase III VAYHIT2 Trial Demonstrates Ianalumab Plus Eltrombopag Extends Disease Control in Primary Immune Thrombocytopenia
Medicine

Phase III VAYHIT2 Trial Demonstrates Ianalumab Plus Eltrombopag Extends Disease Control in Primary Immune Thrombocytopenia

adminAugust 13, 2025

Image Credit: © AkuAku – stock.adobe.com Summary The Phase III VAYHIT2 trial evaluated ianalumab plus eltrombopag versus placebo plus eltrombopag…

Phase III EV-303/KEYNOTE-905 Shows Padcev Plus Keytruda Improves Event-Free and Overall Survival in Muscle-Invasive Bladder Cancer
Medicine

Phase III EV-303/KEYNOTE-905 Shows Padcev Plus Keytruda Improves Event-Free and Overall Survival in Muscle-Invasive Bladder Cancer

adminAugust 13, 2025

Image Credit: © Matthieu – stock.adobe.com Summary The Phase III EV-303/KEYNOTE-905 trial showed that Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab),…

Understanding FDA and EMA Guidance on AI and Digital Twin Applications in Trials
Medicine

Understanding FDA and EMA Guidance on AI and Digital Twin Applications in Trials

adminAugust 12, 2025

In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed…

Biogen, Stoke Therapeutics Launch Phase III Trial of Investigational Antisense Therapy for Dravet Syndrome
Medicine

Biogen, Stoke Therapeutics Launch Phase III Trial of Investigational Antisense Therapy for Dravet Syndrome

adminAugust 11, 2025August 11, 2025

Image Credit: Adobe Stock Images/Magnimage Topline Findings First Patient Dosed: Biogen and Stoke Therapeutics initiate Phase III EMPEROR trial of…

Tegoprazan Shows Superior Maintenance of Healing in Phase III TRIUMpH Study of Gastroesophageal Reflux Disease
Medicine

Tegoprazan Shows Superior Maintenance of Healing in Phase III TRIUMpH Study of Gastroesophageal Reflux Disease

adminAugust 11, 2025

Image Credit: © Satjawat – stock.adobe.com Summary The TRIUMpH Phase III program demonstrated that tegoprazan maintained healing in GERD patients…

Eli Lilly’s Investigational Oral GLP-1 Receptor Agonist Demonstrates Significant Weight Loss
Medicine

Eli Lilly’s Investigational Oral GLP-1 Receptor Agonist Demonstrates Significant Weight Loss

adminAugust 10, 2025

Image Credit: Adobe Stock Images/freebird7977 Topline Findings Orforglipron delivers strong weight loss results: Lilly’s oral GLP-1 candidate achieved up to…

Best Practices for Operational Alignment in Decentralized Trials
Medicine

Best Practices for Operational Alignment in Decentralized Trials

adminAugust 10, 2025

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed…

AI-Powered Non-Interventional Research Delivers What DCTs Promised
Medicine

AI-Powered Non-Interventional Research Delivers What DCTs Promised

adminAugust 9, 2025

Image Credit: © Kaikoro – stock.adobe.com Summary AI-powered, unified digital platforms are streamlining non-interventional studies by removing site dependencies, accelerating…

Zusduri Demonstrates Sustained Efficacy in Phase III ENVISION Trial for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Medicine

Zusduri Demonstrates Sustained Efficacy in Phase III ENVISION Trial for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

adminAugust 9, 2025

Image Credit: © Matthieu – stock.adobe.com Summary The Phase III ENVISION trial 24-month update shows Zusduri maintained a 72.2% duration…

Genmab’s Epkinly Shows Major Survival Benefit in Relapsed, Refractory Follicular Lymphoma
Medicine

Genmab’s Epkinly Shows Major Survival Benefit in Relapsed, Refractory Follicular Lymphoma

adminAugust 8, 2025August 8, 2025

Image Credit: Adobe Stock Images/Johannes Topline Findings Positive Phase III Trial Results: Genmab’s Epkinly (epcoritamab) combined with Rituxan (rituximab) and…

The Power of Digital Twins in Predicting Outcomes for Clinical Trials
Medicine

The Power of Digital Twins in Predicting Outcomes for Clinical Trials

adminAugust 8, 2025

In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed…

Breaking Down Data Silos to Enable Real-Time Trial Oversight
Medicine

Breaking Down Data Silos to Enable Real-Time Trial Oversight

adminAugust 7, 2025

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed…

FDA Supports Continued Development of Eftilagimod Alfa in PD-L1–Negative Head and Neck Cancer
Medicine

FDA Supports Continued Development of Eftilagimod Alfa in PD-L1–Negative Head and Neck Cancer

adminAugust 7, 2025

Credit: Lars Neumann | stock.adobe.com Summary The FDA has endorsed further development of Immutep’s eftilagimod alfa (efti) in combination with…

HHS Cancellation of $500M in BARDA mRNA Vaccine Contracts May Lead to Stricter Trial Design Oversight, Funding
Medicine

HHS Cancellation of $500M in BARDA mRNA Vaccine Contracts May Lead to Stricter Trial Design Oversight, Funding

adminAugust 6, 2025August 6, 2025

Image Credit: © Tada Images – stock.adobe.com Summary HHS has canceled 22 BARDA-funded mRNA vaccine contracts, totaling $500 million, as…

Strategies to Accelerate Modern Clinical Trials
Medicine

Strategies to Accelerate Modern Clinical Trials

adminAugust 6, 2025

Cindy Henderson, chief strategy officer, Veristat Summary Protocol complexity is rising across therapeutic areas, driving costly delays and frequent amendments—now…

How Remote Monitoring Enhances Trial Efficiency and Patient Safety
Medicine

How Remote Monitoring Enhances Trial Efficiency and Patient Safety

adminAugust 5, 2025

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed…

Why Real-Time Data Visibility Is Essential for Biotech Clinical Trials
Medicine

Why Real-Time Data Visibility Is Essential for Biotech Clinical Trials

adminAugust 5, 2025

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed…

Clinical Trial Failure Isn’t an Inevitable Risk—It’s Insurable and Opening the Door to New Investors
Medicine

Clinical Trial Failure Isn’t an Inevitable Risk—It’s Insurable and Opening the Door to New Investors

adminAugust 4, 2025

Image Credit: © photon_photo – stock.adobe.com Key takeaways Nearly 70% of Phase II trials fail, often due to preventable issues…

Placebos, Politics, and the Ethics of Vaccine Trials
Medicine

Placebos, Politics, and the Ethics of Vaccine Trials

adminAugust 4, 2025August 4, 2025

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three…

Cardiff Reports 49% Response Rate With Onvansertib in RAS-Mutated Colorectal Cancer
Medicine

Cardiff Reports 49% Response Rate With Onvansertib in RAS-Mutated Colorectal Cancer

adminAugust 3, 2025

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Key takeaways The 30 mg onvansertib arm demonstrated a 49% confirmed ORR versus…

Adapting to a Changing Research Funding Landscape
Medicine

Adapting to a Changing Research Funding Landscape

adminAugust 3, 2025

In a recent video interview with Applied Clinical Trials, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research…

FDA Clears Alphamab’s Anti-HER2 Biparatopic Antibody-Drug Conjugate for Phase II Ovarian Cancer Trial
Medicine

FDA Clears Alphamab’s Anti-HER2 Biparatopic Antibody-Drug Conjugate for Phase II Ovarian Cancer Trial

adminAugust 2, 2025

Image Credit: Adobe Stock Images/Pete Key Takeaways FDA Approval for JSKN003 Trial: Alphamab Oncology received FDA approval to start a…

Monthly Ivermectin Cuts Malaria Infection by 26% in Kenyan Phase III BOHEMIA Trial
Medicine

Monthly Ivermectin Cuts Malaria Infection by 26% in Kenyan Phase III BOHEMIA Trial

adminAugust 2, 2025

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Monthly ivermectin administration reduced malaria incidence by 26% versus albendazole, meeting WHO…

Obicetrapib Shows Alzheimer’s Biomarker Reduction in Phase III BROADWAY Trial
Medicine

Obicetrapib Shows Alzheimer’s Biomarker Reduction in Phase III BROADWAY Trial

adminAugust 1, 2025

Image Credit: Adobe Stock Images/MUdaylah Key takeaways Obicetrapib 10 mg significantly reduced plasma p-tau217 levels over 12 months in both…

AI Summary Test
Medicine

AI Summary Test

adminAugust 1, 2025

AI Summary Test

Kisunla Slows Cognitive and Functional Decline Over Three Years in Phase III Alzheimer Long-Term Extension Trial
Medicine

Kisunla Slows Cognitive and Functional Decline Over Three Years in Phase III Alzheimer Long-Term Extension Trial

adminJuly 31, 2025

Image Credit: Adobe Stock Images/Orawan Key Takeaways Sustained Benefit Over Three Years: Kisunla continued to slow cognitive and functional decline…

VYNE Ends Phase IIb Vitiligo Trial of Repibresib After Missing Primary Endpoint
Medicine

VYNE Ends Phase IIb Vitiligo Trial of Repibresib After Missing Primary Endpoint

adminJuly 31, 2025

Image Credit: © Axel Bueckert – stock.adobe.com Key takeaways Repibresib missed both primary and key secondary endpoints in Phase IIb,…

AbbVie Reports Positive Phase III Results for Upadacitinib in Severe Alopecia Areata
Medicine

AbbVie Reports Positive Phase III Results for Upadacitinib in Severe Alopecia Areata

adminJuly 30, 2025

Credit: Alex Papp | stock.adobe.com Key takeaways Robust primary endpoint success: Upadacitinib achieved ≥80% scalp hair coverage in over half…

AbbVie Submits sNDA to FDA for Venclexta-Acalabrutinib Combo in Frontline CLL
Medicine

AbbVie Submits sNDA to FDA for Venclexta-Acalabrutinib Combo in Frontline CLL

adminJuly 30, 2025

Image Credit: © chayantorn – stock.adobe.com Key takeaways The AMPLIFY trial supports a fixed-duration, all-oral regimen of venetoclax and acalabrutinib,…

J&J Submits sBLA to FDA for Tremfya Label Expansion Based on PsA Joint Damage Inhibition Data
Medicine

J&J Submits sBLA to FDA for Tremfya Label Expansion Based on PsA Joint Damage Inhibition Data

adminJuly 29, 2025

Credit: and.one | stock.adobe.com Key takeaways J&J has submitted an sBLA to the FDA seeking to update Tremfya’s label to…

Ilumya Achieves Positive Phase III Results in Psoriatic Arthritis Trials
Medicine

Ilumya Achieves Positive Phase III Results in Psoriatic Arthritis Trials

adminJuly 29, 2025

Credit: Andrii | stock.adobe.com Key takeaways Ilumya demonstrated statistically significant ACR20 responses at Week 24 in both biologic-experienced and biologic-naïve…

Rethinking Oncology Trials With a Statistical Methodology That Puts Patients First
Medicine

Rethinking Oncology Trials With a Statistical Methodology That Puts Patients First

adminJuly 28, 2025

Rudradev Sengupta, Senior Trial Design Lead at One2Treat Key takeaways Net treatment benefit (NTB) provides a more holistic, multidimensional assessment…

Tagrisso Plus Chemotherapy Significantly Improves Overall Survival in EGFR-Mutated NSCLC, FLAURA2 Final Results Show
Medicine

Tagrisso Plus Chemotherapy Significantly Improves Overall Survival in EGFR-Mutated NSCLC, FLAURA2 Final Results Show

adminJuly 28, 2025

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Key takeaways Final FLAURA2 data show Tagrisso plus chemotherapy significantly improves overall survival…

Clinical Trial Searches Delay Treatment for Nearly 75% of Physicians
Medicine

Clinical Trial Searches Delay Treatment for Nearly 75% of Physicians

adminJuly 27, 2025July 27, 2025

Image Credit: Adobe Stock Images/jam Key Takeaways Clinical trial searches are delaying treatment: Around 72% of physicians in the United…

Balancing DEI Reporting With Legal Risk
Medicine

Balancing DEI Reporting With Legal Risk

adminJuly 27, 2025

In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the…

Performing Risk Assessments Amid Shifting Federal Guidelines
Medicine

Performing Risk Assessments Amid Shifting Federal Guidelines

adminJuly 26, 2025

In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the…

Alexion’s Dual-Binding Nanobody Demonstrates Statistically Significant Improvements in Generalized Myasthenia Gravis
Medicine

Alexion’s Dual-Binding Nanobody Demonstrates Statistically Significant Improvements in Generalized Myasthenia Gravis

adminJuly 26, 2025

Image Credit: Adobe Stock Images/Robin Key Takeaways Gefurulimab shows promise in generalized myasthenia gravis (gMG) treatment: Phase III PREVAIL trial…

What July’s CRLs to Replimune and Capricor Mean for Sponsors
Medicine

What July’s CRLs to Replimune and Capricor Mean for Sponsors

adminJuly 25, 2025

Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways Expect heightened scrutiny of trial design: Recent CRLs underscore that even previously…

Obefazimod Achieves Clinical Remission in Phase III Ulcerative Colitis Trials
Medicine

Obefazimod Achieves Clinical Remission in Phase III Ulcerative Colitis Trials

adminJuly 25, 2025

Image Credit: Adobe Stock Images/Bungon Key Takeaways Obefazimod delivers statistically significant clinical remission in Ulcerative Colitis (UC): The 50 mg…

Astegolimab Shows Mixed Results in COPD Trials, Meeting Endpoint in ALIENTO but Not in ARNASA
Medicine

Astegolimab Shows Mixed Results in COPD Trials, Meeting Endpoint in ALIENTO but Not in ARNASA

adminJuly 24, 2025July 24, 2025

Image Credit: © peterschreiber.media – stock.adobe.com Key takeaways The ALIENTO Phase IIb study met its primary endpoint, demonstrating a 15.4%…

FDA’s Elsa AI Tool Raises Accuracy and Oversight Concerns
Medicine

FDA’s Elsa AI Tool Raises Accuracy and Oversight Concerns

adminJuly 24, 2025

Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways FDA’s internal AI assistant, Elsa, has experienced accuracy issues, including generating false…

The Quiet Risks of Ignoring Executive Orders in Research
Medicine

The Quiet Risks of Ignoring Executive Orders in Research

adminJuly 23, 2025

In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the…

Understanding Executive Orders and Trial Compliance
Medicine

Understanding Executive Orders and Trial Compliance

adminJuly 23, 2025

In a recent video interview with Applied Clinical Trials, Kate Gallin, Heffernan, life sciences attorney, Epstein Becker Green, discussed the…

What Clinical Researchers Need to Know About Global Obesity Drug Development
Medicine

What Clinical Researchers Need to Know About Global Obesity Drug Development

adminJuly 22, 2025

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics…

Viatris Updates Phase III Blepharitis Trial of MR-139, Highlights Progress in Presbyopia and Night Vision Programs
Medicine

Viatris Updates Phase III Blepharitis Trial of MR-139, Highlights Progress in Presbyopia and Night Vision Programs

adminJuly 22, 2025

Image Credit: © Pixel-Shot – stock.adobe.com Key takeaways The MR-139 blepharitis trial missed its primary endpoint, prompting reevaluation of future…

Social Media Outperforms Traditional Methods for Recruiting Patients with Depression in Clinical Trials
Medicine

Social Media Outperforms Traditional Methods for Recruiting Patients with Depression in Clinical Trials

adminJuly 21, 2025

Image Credit: Adobe Stock Images/Jorm Sangsorn Key Takeaways Online recruitment boosts trial efficiency and diversity: Social media platforms such as…

How Parexel Supports Cross Functional Trials for Emerging GLP-1 Therapies
Medicine

How Parexel Supports Cross Functional Trials for Emerging GLP-1 Therapies

adminJuly 21, 2025

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of…

Advice for CROs and Sponsors Partnering With Retail Trial Sites
Medicine

Advice for CROs and Sponsors Partnering With Retail Trial Sites

adminJuly 20, 2025

In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone…

The Future of Clinical Trials in Community-Based Settings
Medicine

The Future of Clinical Trials in Community-Based Settings

adminJuly 20, 2025

In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone…

Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
Medicine

Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence

adminJuly 19, 2025

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of…

Phase IIIb VOLITION Trial Shows Strong Patient Preference for Long-Acting HIV Therapy After Rapid Suppression on Oral Treatment
Medicine

Phase IIIb VOLITION Trial Shows Strong Patient Preference for Long-Acting HIV Therapy After Rapid Suppression on Oral Treatment

adminJuly 19, 2025

Image Credit: © Ezume Images – stock.adobe.com Key takeaways 89% of eligible participants in the VOLITION trial chose to switch…

ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma
Medicine

ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma

adminJuly 18, 2025

Image Credit: Adobe Stock Images/Khella Key Takeaways ODAC vote raises safety concerns over Blenrep combinations: FDA advisory panel cited significant…

Gilead’s Yeztugo Demonstrates Strong HIV Prevention Results in Underserved Populations
Medicine

Gilead’s Yeztugo Demonstrates Strong HIV Prevention Results in Underserved Populations

adminJuly 18, 2025

Image Credit: Adobe Stock Images/Nurillo Key Takeaways Twice-yearly pre-exposure prophylaxis (PrEP) shows strong efficacy: Yeztugo prevented HIV infections in pregnant…

Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
Medicine

Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis

adminJuly 17, 2025

Image Crddit: © yanapopovaiv – stock.adobe.com Key takeaways The Phase III CARES program evaluating anselamimab did not meet its primary…

SurVaxM Shows Continued Promise in Glioblastoma as Phase IIb SURVIVE Trial Progresses
Medicine

SurVaxM Shows Continued Promise in Glioblastoma as Phase IIb SURVIVE Trial Progresses

adminJuly 17, 2025

Image Credit: © stockdevil – stock.adobe.com Key takeaways Interim analysis from the randomized Phase IIb SURVIVE trial supports continued evaluation…

Imugene’s Azer-Cel Shows Promise in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Medicine

Imugene’s Azer-Cel Shows Promise in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

adminJuly 16, 2025

Image Credit: Adobe Stock Images/Green Creator Key Takeaways Azer-cel shows strong response rates in relapsed/refractory diffuse large B-cell lymphoma (DLBCL):…

GLP-1 Avexitide Continues to Show Promise in Reducing Hypoglycemia After Bariatric Surgery in Phase II Trials
Medicine

GLP-1 Avexitide Continues to Show Promise in Reducing Hypoglycemia After Bariatric Surgery in Phase II Trials

adminJuly 16, 2025

Image Credit: © cacaroot – stock.adobe.com Key takeaways Phase II data show avexitide significantly reduces Level 2 and 3 hypoglycemic…

Building Clinical Trial Infrastructure Inside Pharmacies
Medicine

Building Clinical Trial Infrastructure Inside Pharmacies

adminJuly 15, 2025

In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone…

Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
Medicine

Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527

adminJuly 15, 2025

Image Credit: © Ezume Images – stock.adobe.com Key takeaways Merck has launched the Phase III EXPrESSIVE program to evaluate MK-8527,…

Walgreens’ Clinical Trials Journey: Three Years In
Medicine

Walgreens’ Clinical Trials Journey: Three Years In

adminJuly 14, 2025

In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone…

Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
Medicine

Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management

adminJuly 14, 2025

Image Credit: © Proxima Studio – stock.adobe.com Key takeaways Once-weekly efsitora may streamline insulin initiation for insulin-naïve type 2 diabetes…

EMBARK Trial Shows Xtandi Combination Demonstrates Significant Overall Response in Non-Metastatic Hormone-Sensitive Prostate Cancer
Medicine

EMBARK Trial Shows Xtandi Combination Demonstrates Significant Overall Response in Non-Metastatic Hormone-Sensitive Prostate Cancer

adminJuly 13, 2025

Image Credit: Adobe Stock Images/MohammedElAmine Key Takeaways Xtandi plus leuprolide significantly improves overall survival: In patients with non-metastatic hormone-sensitive prostate…

Designing Trials Around the Full Patient Journey
Medicine

Designing Trials Around the Full Patient Journey

adminJuly 13, 2025July 13, 2025

In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and…

New FDA Initiative Reveals Common Reasons for Drug Application Rejection
Medicine

New FDA Initiative Reveals Common Reasons for Drug Application Rejection

adminJuly 12, 2025

Image Credit: Adobe Stock Images/Tada Images Key Takeaways FDA publishes over 200 complete response letters (CRLs): The agency released CRLs…

How AI Teammates Will Finally Bring Us Into the Modern Era
Medicine

How AI Teammates Will Finally Bring Us Into the Modern Era

adminJuly 12, 2025

Gaurav Bhatnagar, Chief Growth Officer, Tilda Research In an era where artificial intelligence (AI) writes poetry, self-driving cars navigate complex…

Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
Medicine

Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances

adminJuly 11, 2025

Image Credit: © Matthieu – stock.adobe.com Key takeaways Orphan drug designation for quemliclustat highlights regulatory momentum and unmet need in…

Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
Medicine

Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+

adminJuly 11, 2025

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Large-Scale, Multinational Trial Design: The P304 study enrolled over 40,000 participants across…

Removing Financial Barriers to Boost Trial Diversity
Medicine

Removing Financial Barriers to Boost Trial Diversity

adminJuly 10, 2025

In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and…

Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
Medicine

Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor

adminJuly 10, 2025

Image Credit: © Aerial Mike – stock.adobe.com Key takeaways Long-term ENLIVEN data reinforce the value of extended follow-up in rare…

KEYNOTE-689 Trial Shows Perioperative Keytruda Significantly Improves Survival in Resectable Locally Advanced HNSCC
Medicine

KEYNOTE-689 Trial Shows Perioperative Keytruda Significantly Improves Survival in Resectable Locally Advanced HNSCC

adminJuly 9, 2025

Credit: steph photographies | stock.adobe.com Key Takeaways Perioperative Immunotherapy Boosts EFS. The KEYNOTE-689 trial demonstrated that adding neoadjuvant and adjuvant…

Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment
Medicine

Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment

adminJuly 9, 2025July 9, 2025

Christine Senn, PhD, FACRP is the SVP of Site-Sponsor Innovation at Advarra Key takeaways Modernize processes for site-initiated ads: Sponsors…

Removing Barriers for Underserved Patients
Medicine

Removing Barriers for Underserved Patients

adminJuly 8, 2025

In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and…

FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
Medicine

FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results

adminJuly 8, 2025

Credit: magicmine | stock.adobe.com Key takeaways The expanded FDA approval of Farapulse introduces a non-thermal ablation option for persistent AF,…

Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success
Medicine

Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success

adminJuly 7, 2025

Credit: Egor | stock.adobe.com Key Takeaways AI and Machine Learning Are Revolutionizing Trial Design. Artificial intelligence (AI) and machine learning…

The Impact of ICH E6(R3) on Biospecimen Management
Medicine

The Impact of ICH E6(R3) on Biospecimen Management

adminJuly 7, 2025

With the EMA adopting ICH E6(R3) in July, sponsors with EU trial operations must now meet stricter regulations that directly…

How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials
Medicine

How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials

adminJuly 6, 2025July 6, 2025

In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient…

Leveraging remote-based regional hubs in FSP partnerships
Medicine

Leveraging remote-based regional hubs in FSP partnerships

adminJuly 6, 2025

April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA…

Phase III GEMZ Trial Meets Primary Endpoint for Fenfluramine in CDKL5 Deficiency Disorder
Medicine

Phase III GEMZ Trial Meets Primary Endpoint for Fenfluramine in CDKL5 Deficiency Disorder

adminJuly 5, 2025

Image Credit: © rost9 – stock.adobe.com Key takeaways Rare disease trial design requires careful structuring: The GEMZ trial’s two-part, multi-phase…

How Sites and Sponsors Are Adapting to Clinical Trial Budget Cuts
Medicine

How Sites and Sponsors Are Adapting to Clinical Trial Budget Cuts

adminJuly 5, 2025

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts…

FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
Medicine

FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial

adminJuly 4, 2025

Credit: samunella | stock.adobe.com Key takeaways Early trial termination for efficacy signals strong clinical benefit: The ZENITH trial was halted…

AI Levels the Playing Field in Trial Recruitment
Medicine

AI Levels the Playing Field in Trial Recruitment

adminJuly 4, 2025

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts…

The Next Leap in Clinical Trial Delivery
Medicine

The Next Leap in Clinical Trial Delivery

adminJuly 3, 2025

Image Credit: © putilov_denis – stock.adobe.com Key takeaways Automation must evolve into intelligence: Traditional automation has reached its limits—future-ready trials…

Amgen’s Bemarituzumab-Chemotherapy Combination Significantly Improves Overall Survival in Unresectable Locally Advanced or Metastatic G/GEJ Cancer
Medicine

Amgen’s Bemarituzumab-Chemotherapy Combination Significantly Improves Overall Survival in Unresectable Locally Advanced or Metastatic G/GEJ Cancer

adminJuly 3, 2025

Image Credit: Adobe Stock Images/mi_viri Key Takeaways Bemarituzumab Shows Survival Benefit: The Phase III FORTITUDE-101 trial met its primary endpoint,…

How AI Can Ease Recruitment Burdens in Resource-Strained Trials
Medicine

How AI Can Ease Recruitment Burdens in Resource-Strained Trials

adminJuly 2, 2025July 2, 2025

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts…

Using Real-World Data to Bridge the Clinical Trial Divide
Medicine

Using Real-World Data to Bridge the Clinical Trial Divide

adminJuly 2, 2025

Image Credit: © photon_photo – stock.adobe.com Key takeaways Clinical trial populations often don’t reflect the diversity or complexity of real-world…

REDEFINE 1 Trial Finds Cagrilintide–Semaglutide Combo Delivers Over 20% Weight Loss in Majority of Patients
Medicine

REDEFINE 1 Trial Finds Cagrilintide–Semaglutide Combo Delivers Over 20% Weight Loss in Majority of Patients

adminJuly 1, 2025

Credit: Daniel Krasoń | stock.adobe.com. Key Takeaways Unprecedented Weight Loss Outcomes. In the REDEFINE 1 trial, 60% of participants receiving…

How Funding Cuts Are Undermining Patient Recruitment in Clinical Trials
Medicine

How Funding Cuts Are Undermining Patient Recruitment in Clinical Trials

adminJuly 1, 2025

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts…

Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
Medicine

Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy

adminJune 30, 2025

Credit: Crystal light | stock.adobe.com Key Takeaways First Phase III Trial for Felzartamab in PMN: Biogen has initiated dosing in…

Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships
Medicine

Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships

adminJune 30, 2025

April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA…

2025 FSP Trends Report
Medicine

2025 FSP Trends Report

adminJune 29, 2025

April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA…

Efruxifermin Shows Long-Term Promise in MASH-Related Cirrhosis Despite Missing Primary Endpoint in Phase IIb Trial
Medicine

Efruxifermin Shows Long-Term Promise in MASH-Related Cirrhosis Despite Missing Primary Endpoint in Phase IIb Trial

adminJune 29, 2025June 29, 2025

Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways Missed Primary Endpoint at 36 Weeks. Efruxifermin did not significantly reduce fibrosis without…

Funding Cuts Threaten Diversity in Clinical Research
Medicine

Funding Cuts Threaten Diversity in Clinical Research

adminJune 28, 2025

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts…

Key Examples From ASCO 2025
Medicine

Key Examples From ASCO 2025

adminJune 28, 2025

Shadi Cinpinski, MHA, Director, Therapeutic Strategy, Oncology, IQVIA Jim Routt, Vice President and Unit Head, Oncology Global Therapeutic Delivery, IQVIA…

Talvey and Tecvayli Combo Shows Strong, Durable Responses in High-Risk Multiple Myeloma with Extramedullary Disease in Phase II Trial
Medicine

Talvey and Tecvayli Combo Shows Strong, Durable Responses in High-Risk Multiple Myeloma with Extramedullary Disease in Phase II Trial

adminJune 27, 2025

Credit: David A Litman | stock.adobe.com. Key Takeaways High Overall Response Rate. Talvey and Tecvayli combination achieved a 78.9% overall…

Pfizer Reports Strong Phase III Results for Hympavzi in Hemophilia Patients with Inhibitors
Medicine

Pfizer Reports Strong Phase III Results for Hympavzi in Hemophilia Patients with Inhibitors

adminJune 27, 2025

Image Credit: © Design Cells – stock.adobe.com Key takeaways Strong Prophylactic Efficacy: Hympavzi achieved a 93% reduction in annualized bleeding…

AI-Augmented Data, Processes, and People
Medicine

AI-Augmented Data, Processes, and People

adminJune 26, 2025

Key takeaways Data and AI are redefining clinical trial operations, requiring end-to-end data strategies, trustworthy AI frameworks, and a shift…

STEP UP Trial Shows Higher Dose of Wegovy Produces Significant Weight Loss in Adults With Obesity Without Diabetes
Medicine

STEP UP Trial Shows Higher Dose of Wegovy Produces Significant Weight Loss in Adults With Obesity Without Diabetes

adminJune 26, 2025

Credit: Key design | stock.adobe.com. Higher-Dose Semaglutide Shows Enhanced Efficacy Key Takeaways Higher-Dose Semaglutide Shows Enhanced Efficacy. The investigational 7.2…

How CRO Partnerships Are Evolving to Meet Changing Industry Demands
Medicine

How CRO Partnerships Are Evolving to Meet Changing Industry Demands

adminJune 25, 2025

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent…

The Unsexy Plumbing of Clinical Research
Medicine

The Unsexy Plumbing of Clinical Research

adminJune 25, 2025

Image Credit: © putilov_denis – stock.adobe.com Key takeaways Tokenization enhances real-world evidence integration: Tokenization enables researchers to securely link clinical…

MariTide Shows Up to 20% Weight Loss in Phase II Trial for Obesity, Type 2 Diabetes
Medicine

MariTide Shows Up to 20% Weight Loss in Phase II Trial for Obesity, Type 2 Diabetes

adminJune 24, 2025

Credit: New Africa | stock.adobe.com Key Takeaways Up to 20% Weight Loss Achieved with Monthly Dosing. MariTide demonstrated mean weight…

How Human-Centered Design Unlocks AI’s Promise in Pharma
Medicine

How Human-Centered Design Unlocks AI’s Promise in Pharma

adminJune 24, 2025

Eric Karofsky is an award-winning CX, UX, and employee engagement industry expert who leads VectorHX, a human experience agency. Key…

Fostering a Unified Team Culture in Sponsor and CRO Partnerships
Medicine

Fostering a Unified Team Culture in Sponsor and CRO Partnerships

adminJune 23, 2025

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent…

FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
Medicine

FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies

adminJune 23, 2025

Credit: Tada Images | stock.adobe.com Key Takeaways FDA fast-tracks reviews for priority drugs: The new Commissioner’s National Priority Voucher (CNPV)…

The Truth About AI Adoption Speed in Clinical Research
Medicine

The Truth About AI Adoption Speed in Clinical Research

adminJune 22, 2025

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the…

Building Strong CRO-Sponsor Partnerships to Improve Clinical Trial Success
Medicine

Building Strong CRO-Sponsor Partnerships to Improve Clinical Trial Success

adminJune 22, 2025

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent…

Why AI and Automation Are Set to Become the New Normal in Clinical Research
Medicine

Why AI and Automation Are Set to Become the New Normal in Clinical Research

adminJune 21, 2025June 21, 2025

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the under-recognized but impactful role of the public sector—particularly the…

Bridging Communication Gaps to Strengthen CRO-Sponsor Collaboration
Medicine

Bridging Communication Gaps to Strengthen CRO-Sponsor Collaboration

adminJune 21, 2025June 21, 2025

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent…

Phase III OASIS-4 Trial Shows Elinzanetant Significantly Reduces Endocrine Therapy–Related Vasomotor Symptoms in Patients with HR-Positive Breast Cancer
Medicine

Phase III OASIS-4 Trial Shows Elinzanetant Significantly Reduces Endocrine Therapy–Related Vasomotor Symptoms in Patients with HR-Positive Breast Cancer

adminJune 20, 2025

Credit: steph photographies | stock.adobe.com Key Takeaways Elinzanetant Significantly Reduces Vasomotor Symptoms. Patients receiving elinzanetant experienced a statistically significant reduction…

Preparing Operational Teams for AI Workflows in Drug Development
Medicine

Preparing Operational Teams for AI Workflows in Drug Development

adminJune 20, 2025

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the…

Phase II TRANSCEND FL Shows Breyanzi Achieves Strong Efficacy, Durable Response in Relapsed Marginal Zone Lymphoma
Medicine

Phase II TRANSCEND FL Shows Breyanzi Achieves Strong Efficacy, Durable Response in Relapsed Marginal Zone Lymphoma

adminJune 19, 2025June 19, 2025

Credit: Lisa | stock.adobe.com Key Takeaways Breyanzi Achieves High Overall Response Rate in R/R MZL. In the Phase II TRANSCEND FL…

Designing Patient Friendly Digital Health Solutions
Medicine

Designing Patient Friendly Digital Health Solutions

adminJune 19, 2025

In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient…

How Wearable ECGs Enhance Patient Monitoring in Drug Trials
Medicine

How Wearable ECGs Enhance Patient Monitoring in Drug Trials

adminJune 18, 2025

Image Credit: © photon_photo – stock.adobe.com Key takeaways Wearable ECG devices are transforming cardiac safety monitoring by enabling continuous, real-world…

Public Sector Sets the Pace for AI in Drug Discovery and Approval
Medicine

Public Sector Sets the Pace for AI in Drug Discovery and Approval

adminJune 18, 2025

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the…

How Clinical Operations Teams Are Adapting to Oncology Trial Challenges
Medicine

How Clinical Operations Teams Are Adapting to Oncology Trial Challenges

adminJune 17, 2025

In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer…

Putting Patients at the Center of Trial Design and Decision-Making
Medicine

Putting Patients at the Center of Trial Design and Decision-Making

adminJune 17, 2025

ACT: What are some of the most exciting themes or trends in clinical research you’re looking to explore at this…

How Central Labs Are Powering Decentralized and Hybrid Clinical Trials
Medicine

How Central Labs Are Powering Decentralized and Hybrid Clinical Trials

adminJune 16, 2025

Megan Bailey, EVP and president of central laboratories and international, Labcorp Key takeaways Central labs are becoming strategic trial partners,…

Understanding the Challenges Preventing Cancer Patients from Joining Trials
Medicine

Understanding the Challenges Preventing Cancer Patients from Joining Trials

adminJune 16, 2025June 16, 2025

In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer…

Detecting Fraud in Clinical Trials Using Statistical Data Monitoring
Medicine

Detecting Fraud in Clinical Trials Using Statistical Data Monitoring

adminJune 15, 2025

Image Credit: © Murrstock – stock.adobe.com “Identifying … potential data manipulation and data integrity problems” are an International Council for…

Empowering Clinicians to Communicate Clinical Trial Opportunities Effectively
Medicine

Empowering Clinicians to Communicate Clinical Trial Opportunities Effectively

adminJune 15, 2025

In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer…

Phase III POETYK PsA Trials Show Significant Clinical Benefit with Sotyktu in Psoriatic Arthritis
Medicine

Phase III POETYK PsA Trials Show Significant Clinical Benefit with Sotyktu in Psoriatic Arthritis

adminJune 14, 2025

Credit: Andrii | stock.adobe.com Key Takeaways Sotyktu Meets Primary Endpoint in POETYK PsA-1 Trial. In the Phase III POETYK PsA-1…

What Actually Moves the Needle on Inclusive Research
Medicine

What Actually Moves the Needle on Inclusive Research

adminJune 14, 2025June 14, 2025

Rebecca Johnson, PhD, Clinical Research Recruitment and Inclusion Executive and Strategist Key Takeaways Progress toward inclusive trials without mandates. Even…

Science is Moving—Clinical Trials Must Catch Up
Medicine

Science is Moving—Clinical Trials Must Catch Up

adminJune 13, 2025June 13, 2025

Allison Cuff Shimooka, Chief Operating Officer, TransCelerate BioPharma Key Takeaways Clinical trial processes lag behind scientific and technological advances. While…

Navigating the Intersection of Accessibility and Measurement Integrity in eCOA
Medicine

Navigating the Intersection of Accessibility and Measurement Integrity in eCOA

adminJune 13, 2025

Over the last half a century or so, clinical research has progressively shifted from a somewhat paternalistic focus on physiological…

Rethinking Feasibility in the Attention Economy
Medicine

Rethinking Feasibility in the Attention Economy

adminJune 12, 2025June 12, 2025

Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen Key Takeaways Eligibility ≠ participation. While many users meet trial eligibility criteria,…

Preparing to Achieve with Joint Clinical Assessments
Medicine

Preparing to Achieve with Joint Clinical Assessments

adminJune 12, 2025June 12, 2025

Graham Bell Director, Global Regulatory Strategy, ICON plc Key Takeaways Joint Clinical Assessment is now a parallel requirement under HTAR.Health…

Phase IIIb APEX Trial Finds Tremfya Significantly Slows Joint Damage Progression in Psoriatic Arthritis
Medicine

Phase IIIb APEX Trial Finds Tremfya Significantly Slows Joint Damage Progression in Psoriatic Arthritis

adminJune 11, 2025

Credit: and.one | stock.adobe.com Key Takeaways Tremfya Reduces Structural Joint Damage in PsA. Phase IIIb APEX trial results show that…

First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
Medicine

First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer

adminJune 11, 2025June 11, 2025

Image Credit: © LASZLO – stock.adobe.com Key takeaways Phase III Trial Explores Enhertu Combo in Endometrial Cancer: DESTINY-Endometrial01 is assessing…

How Sponsors, CROs, and Sites Can Align
Medicine

How Sponsors, CROs, and Sites Can Align

adminJune 10, 2025

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed…

Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting
Medicine

Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting

adminJune 10, 2025

Image Credit: © putilov_denis – stock.adobe.com Key takeaways Transparent FMV practices are critical: Open and collaborative FMV calculations help build…

Unlocking the Full Potential of MCRCs in Clinical Development
Medicine

Unlocking the Full Potential of MCRCs in Clinical Development

adminJune 9, 2025

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed…

How Trump’s Most Favored Nation Policy Could Impact Funding for Clinical Development
Medicine

How Trump’s Most Favored Nation Policy Could Impact Funding for Clinical Development

adminJune 9, 2025

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed…

Lessons from a Multicentric Study in India
Medicine

Lessons from a Multicentric Study in India

adminJune 8, 2025

Image Credit: © photon_photo – stock.adobe.com Key takeaways Early regulatory engagement prevents delays: Proactively managing protocol amendments and aligning with…

Enhancing Obesity Trials with Integrated eCOA and Digital Endpoint Technologies
Medicine

Enhancing Obesity Trials with Integrated eCOA and Digital Endpoint Technologies

adminJune 8, 2025June 8, 2025

Join us for an insightful session IQVIA experts Anthony Mikulaschek and Michael Bruhns will share their experience on harnessing the…

Phase III IRAKLIA and Phase II IZALCO Trials Support Sarclisa On-Body Delivery for Relapsed/Refractory Multiple Myeloma
Medicine

Phase III IRAKLIA and Phase II IZALCO Trials Support Sarclisa On-Body Delivery for Relapsed/Refractory Multiple Myeloma

adminJune 7, 2025June 7, 2025

Credit: Saiful52 | stock.adobe.com Key Takeaways On-body delivery system (OBDS) proves non-inferior to IV Sarclisa in multiple myeloma treatment. Data…

Otsuka’s Sibeprenlimab Demonstrates Meaningful Outcomes in Phase III Study for Immunoglobulin A Nephropathy
Medicine

Otsuka’s Sibeprenlimab Demonstrates Meaningful Outcomes in Phase III Study for Immunoglobulin A Nephropathy

adminJune 7, 2025

Image Credit: © Crystal light – stock.adobe.com Key takeaways Promising interim results support APRIL inhibition as a viable IgAN strategy:…

Accelerating Site Activation and Recruitment with MCRC Partnerships
Medicine

Accelerating Site Activation and Recruitment with MCRC Partnerships

adminJune 6, 2025June 6, 2025

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed…

CARTITUDE-1 Trial Shows Carvykti Achieves Durable, Treatment-Free Remissions in Relapsed or Refractory Multiple Myeloma
Medicine

CARTITUDE-1 Trial Shows Carvykti Achieves Durable, Treatment-Free Remissions in Relapsed or Refractory Multiple Myeloma

adminJune 6, 2025

Image Credit: Adobe Stock Images/freshidea Key Takeaways Carvykti Delivers Long-Term Remission: One-third of patients in the CARTITUDE-1 trial achieved at…

Rethinking Clinical Trial Efficiency Amidst Cost Pressures on Pharma
Medicine

Rethinking Clinical Trial Efficiency Amidst Cost Pressures on Pharma

adminJune 5, 2025June 5, 2025

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed…

HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate
Medicine

HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate

adminJune 5, 2025

Image Credit: © Tada Images – stock.adobe.com Key takeaways HHS has pulled a $590M grant from Moderna’s H5N1 mRNA flu…

Phase III BREAKWATER Trial Shows Braftovi-Based Regimen Improves Survival in BRAF V600E-Mutant Metastatic Colorectal Cancer
Medicine

Phase III BREAKWATER Trial Shows Braftovi-Based Regimen Improves Survival in BRAF V600E-Mutant Metastatic Colorectal Cancer

adminJune 4, 2025

Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways First-Line Survival Milestone in BRAF V600E mCRCThe Braftovi (encorafenib) combination regimen is the…

Tecentriq and Zepzelca Combo Demonstrates Significant Survival Benefit in Phase III Study for Extensive-Stage Small Cell Lung Cancer
Medicine

Tecentriq and Zepzelca Combo Demonstrates Significant Survival Benefit in Phase III Study for Extensive-Stage Small Cell Lung Cancer

adminJune 4, 2025

Image Credit: © iDoPixBox – stock.adobe.com Key takeaways Tecentriq plus Zepzelca significantly improved both PFS and OS in ES-SCLC maintenance…

Rising API Tariffs Are Forcing Pharma to Shift R&D Resources
Medicine

Rising API Tariffs Are Forcing Pharma to Shift R&D Resources

adminJune 3, 2025

In a recent video interview with Applied Clinical Trials, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost…

AstraZeneca and Daiichi Sankyo Share Positive Data From Phase III DESTINY-Breast09 Trial of Enhertu Plus Pertuzumab
Medicine

AstraZeneca and Daiichi Sankyo Share Positive Data From Phase III DESTINY-Breast09 Trial of Enhertu Plus Pertuzumab

adminJune 3, 2025

Image Credit: © Crystal light – stock.adobe.com Key takeaways Enhertu plus pertuzumab showed a 44% reduction in disease progression or…

Realtime Electronic Data Capture at Investigator Sites: Laboratory Data and Beyond
Medicine

Realtime Electronic Data Capture at Investigator Sites: Laboratory Data and Beyond

adminJune 1, 2025

Introduction Paper-based data capture has been the standard in clinical trials since their inception. In the 1990s, the FDA kicked…

Clinical Trial Monitoring: Should Randomization Be Included?
Medicine

Clinical Trial Monitoring: Should Randomization Be Included?

adminJune 1, 2025

Jennifer Ross, director of biostatistics, and Kevin Venner, group leader, biostatisticians; both with Almac Clinical Technologies Developing a clinical trial’s…

Investigational MK-1084 Demonstrates Antitumor Activity in Phase I Trial for Colorectal and Non-Small Cell Lung Cancers
Medicine

Investigational MK-1084 Demonstrates Antitumor Activity in Phase I Trial for Colorectal and Non-Small Cell Lung Cancers

adminMay 31, 2025

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Early-phase trial design should anticipate combination therapy pathways, as seen with MK-1084…

The Hidden Impact of Drug Pricing on Government Clinical Trials
Medicine

The Hidden Impact of Drug Pricing on Government Clinical Trials

adminMay 31, 2025

In a recent video interview with Applied Clinical Trials, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost…

Daiichi Sankyo and Merck Pull Back Patritumab Deruxtecan BLA Based on Phase III HERTHENA-Lung02 Outcomes
Medicine

Daiichi Sankyo and Merck Pull Back Patritumab Deruxtecan BLA Based on Phase III HERTHENA-Lung02 Outcomes

adminMay 30, 2025

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Key takeaways BLA withdrawn due to lack of OS benefit: The Phase III…

How to Stay Agile in a Fast-Moving Clinical Trial Ecosystem
Medicine

How to Stay Agile in a Fast-Moving Clinical Trial Ecosystem

adminMay 30, 2025

© photon_photo – © photon_photo – stock.adobe.com. Key takeaways AI and tech expertise are becoming core clin ops requirements: Success…

Gilead’s Trodelvy Meets Primary Endpoint of Progression-Free Survival in Phase III ASCENT-03 Breast Cancer Study
Medicine

Gilead’s Trodelvy Meets Primary Endpoint of Progression-Free Survival in Phase III ASCENT-03 Breast Cancer Study

adminMay 29, 2025

Image Credit: © Crystal light – stock.adobe.com Key takeaways Trodelvy achieves primary endpoint in first-line mTNBC: The ASCENT-03 Phase III…

Pimicotinib Succeeds in Phase III MANEUVER Trial, Demonstrates Meaningful Improvements in Tenosynovial Giant Cell Tumor Patients
Medicine

Pimicotinib Succeeds in Phase III MANEUVER Trial, Demonstrates Meaningful Improvements in Tenosynovial Giant Cell Tumor Patients

adminMay 29, 2025

Image Credit: © Aerial Mike – stock.adobe.com Key takeaways Strong ORR validates trial design and execution: The trial achieved a…

New Phase III Data Show Bayer’s Nubeqa Significantly Improves Quality of Life for Prostate Cancer Patients
Medicine

New Phase III Data Show Bayer’s Nubeqa Significantly Improves Quality of Life for Prostate Cancer Patients

adminMay 28, 2025May 28, 2025

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Quality of life metrics matter in mCSPC trials: Post-hoc ARANOTE data shows…

AI-Powered Predictions and Virtual Patient Models
Medicine

AI-Powered Predictions and Virtual Patient Models

adminMay 27, 2025

In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial…

Accelerating Budget Finalization in Global Clinical Trials
Medicine

Accelerating Budget Finalization in Global Clinical Trials

adminMay 27, 2025

Don’t miss IQVIA Technologies’ webinar on clinical trial budgeting. Gain insights into effective budget-building techniques and explore how IQVIA GrantPlan…

Merck and Daiichi Sankyo Launch Global Phase III Trial of Novel Antibody Drug Conjugate in Advanced Esophageal Squamous Cell Carcinoma
Medicine

Merck and Daiichi Sankyo Launch Global Phase III Trial of Novel Antibody Drug Conjugate in Advanced Esophageal Squamous Cell Carcinoma

adminMay 26, 2025May 26, 2025

Credit: Johannes | stock.adobe.com Key Takeaways Phase III IDeate-Esophageal01 Trial LaunchesMerck and Daiichi Sankyo have initiated a global, multicenter Phase…

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