Focus on Fundamentals for Better Collaboration Across Research Sites and Sponsors
Has the explosion of clinical trial technology made study execution too complex? For clinical research sites meeting and treating patients…
Category: Medicine
What Digital Technologies are Being Used to Enhance Clinical Trial Enrollment and Diversity?
Image Credit: © Blue Planet Studio – stock.adobe.com The authors of a recent study published in Sage Journals conducted a…
Phase III Trial Data Show Jardiance Falls Short of Statistical Significance in Reducing Risk of Heart Failure Hospitalization, Death Following Heart Attack
Image credit: peterschreiber.media | stock.adobe.com Findings from the Phase III EMPACT-MI trial show that compared with placebo, patients administered Jardiance (empagliflozin;…
Digital biomarkers show early clinical validity and provide greater confidence in Movement Disorder clinical trials
Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing insights into treatment efficacy.…
Digital Biomarkers Solution shows pathway to reduced clinical trial sample sizes, shorter durations
April 5th 2024 Article Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing…
How Expert Recommendations on Data Collection, Data Flow, Standards and AI can Transform Outcomes
In the past decade, clinical trials have embraced new innovations, including digital technologies like wearables, eCOA, and eSource. These advancements…
Phase III Trial to Evaluate Novel KRAS G12C Covalent Inhibitor Plus Keytruda for NSCLC
Image credit: yodiyim | stock.adobe.com Merck is launching a Phase III clinical trial to analyze the investigational therapy MK-1084 plus…
First-Patient Dosed in Phase II Clinical Trial Evaluating NBI-1070770 in Adults with Major Depressive Disorder
Image Credit: © photon_photo – stock.adobe.com The first patient has been randomized in a Phase II clinical trial which is…
Technology-Enabled Real-World Data and Clinical Research Data Integration in a Clinical Registry Ecosystem for Foundations
Real-world data (RWD) and real-world evidence (RWE) have become indispensable elements in the current clinical research scenario, intertwining seamlessly with…
Sites Expanded for Acclaim-3 Clinical Study of Reqorsa Therapy in Combination with Tecentriq to Treat Small Cell Lung Cancer
Image Credit: © iDoPixBox – stock.adobe.com Through a collaboration agreement with a large network of integrated, community-based oncology practices, Genprex…
Industry Assessment of Risk-Based Quality Management Emphasizes Value of Adoption
Image Credit: © Murrstock – stock.adobe.com The Tufts Center for the Study of Drug Development (Tufts CSDD), in collaboration with…
Enhancing Diversity Through Trial Design
ACT: What does the clinical research industry need to do better to recruit more underrepresented populations into their trials? Tirisham…
First Patient Dosed in Phase IIa Trial of Regenerative Cell Therapy for End-Stage Liver Disease
Image Credit: © photon_photo – stock.adobe.com The first patient has been dosed in an open-label, dose-escalation Phase IIa clinical trial…
Recognition of Multiple Sclerosis in Non-white Populations
ACT: What do you think has caused the lack of awareness when it comes to the recognition of MS in…
Barriers Impacting Patient Enrollment in Lung Cancer Trials
Image Credit: © Andrii Yalanskyi – stock.adobe.com A recent study published in the European Journal of Oncology Nursing (EJON) aimed…
Examining the Current Use of Artificial Intelligence in Clinical Research
Image Credit: © putilov_denis – stock.adobe.com A commentary recently published in the Singapore Medical Journal examined opportunities for the application…
Two Year Trial Data Show Long-Term Efficacy of Izervay for Geographic Atrophy Secondary to Age-Related Macular Degeneration
Image credit: RFBSIP | stock.adobe.com Astellas Pharma Inc. has filed a supplemental New Drug Application (sNDA) with the FDA to…
Designing Clinical Studies in Pain Management
ACT: What should industry be keeping top of mind when it comes to designing and executing pain clinical trials? Greg…
What is Elysium Therapeutics’ O2P?
ACT: Could you tell our audience a bit about O2P and its development journey? Greg Sturmer: O2P, another acronym. We’re…
How High-Quality, Curated Real-World Data from Clinical Data Registries Helps Improve Drug Trials
Image credit: Dmitry | stock.adobe.com A clinical trial is only as good as how well it is designed. For rare…
How Does Elysium Therapeutics’ Hydrocodone Prodrug, O2P, Work?
ACT: Could you tell our audience a bit about O2P and its development journey? Greg Sturmer: When you look at…
Are New Templates Needed to Fill Master Protocols for Integrated Research Platform Trials?
Image Credit: © photon_photo – stock.adobe.com Integrated research platform trials have recently generated more awareness in light of upcoming changes…
Krazati Monotherapy Shows Significant Survival Benefit in KRAS G12C-Mutated NSCLC Per Phase III KRYSTAL-12 Trial Data
Image credit: Dr_Microbe | stock.adobe.com Findings from the Phase III KRYSTAL-12 trial demonstrated that Krazati (adagrasib; Bristol Myers Squibb) monotherapy led…
CSL Behring and Takeda Discuss Advancing Clinical Development and the Future of Trials
At the Veeva R&D and Quality Summit in Boston, Pharmaceutical Executive and Applied Clinical Trials spoke with three industry leaders…
Potential First in Class Treatment for Cirrhosis Shows Positive Results in Phase II Trial
Image credit: klickit24 | stock.adobe.com Data from a Phase II trial (NCT04874350) showed promising topline findings for Lipocine Inc’s potential…
How Often are Retracted microRNA Biomarker Articles Cited in Future Research?
Image Credit: © Sergey Nivens – stock.adobe.com A recent study published in JAMA Network Open aimed to determine whether postretraction…
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
Image credit: pressmaster | stock.adobe.com The FDA has granted Fast Track designation (FTD) Johnson & Johnson’s nipocalimab to lower the…
Including Women of Childbearing Age in Clinical Research
Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about: Specific…
Phase III NextCOVE Trial Data Show Efficacy of Moderna’s Next-Generation COVID-19 Vaccine
Image credit: neirfy | stock.adobe.com Results from the Phase III NextCOVE (NCT05815498) trial demonstrated the efficacy of Moderna’s next-generation COVID-19…
Data Management Efficiencies Through Risk-Based Approaches and Innovations
Image credit: WrightStudio | stock.adobe.com The complexity and number of clinical trials have significantly increased over the past 15 years.…
Results From FLAURA2 Phase III Trial Show Great Benefit from Tagrisso/Chemotherapy Combination in Lung Cancer Patients
Image Credit: © iDoPixBox – stock.adobe.com In combination with chemotherapy, Tagrisso (osimertinib) has showed consistent benefit after disease progression in…
Improving Engagement While Maintaining Data Integrity & Validity
Associate Editor, Miranda Schmalfuhs, and uMotif’s Chief Product Officer, Julia Lakeland, discuss: What kinds of technologies can be developed to…
Challenges in Trial Treatment and Access for Women with Chronic Illnesses
Beyond the data gap for pregnancy, what other specific challenges do women with chronic illnesses face when it comes to…
Unknowns That Can Make or Break a Non-Opioid Analgesic Clinical Trial
Image credit: Feng Yu | stock.adobe.com Many pitfalls are associated with clinical trials of pain therapeutics, accounting for disappointing study…
Five Critical Qualities for Identifying a Partner to Globally Scale Ophthalmology Clinical Trials
Image credit: ryanking999 | stock.adobe.com Biopharmaceutical companies developing vision-improving therapeutics are increasingly focused on drugs to target rare eye diseases.…
The Future of Women’s Health Research
Looking towards the future, what are your thoughts on the role of technology in addressing the data gap in women’s…
Evaluating the Current State of Randomized Platform Clinical Trials
Image Credit: © photon_photo – stock.adobe.com A study recently published on JAMA Network Open found that a group of randomized…
UCB’s Women of Childbearing Age Program
UCB’s Women of Childbearing Age Program is a commendable initiative. Can you tell me more about it and elaborate on…
Top-Line Data of Phase II/III HEALEY ALS Platform Trial Shows Improvements in Function and Mortality
Image Credit: © putilov_denis – stock.adobe.com Top-line data from the Phase II/III HEALEY amyotrophic lateral sclerosis (ALS) clinical trial showed…
Utilizing Generative Artificial Intelligence to Increase the Understandability of Inpatient Discharge Summaries
Image Credit: © Blue Planet Studio – stock.adobe.com A study recently published in JAMA Network Open suggested a large language…
Opdivo plus Yervoy Shows Survival Benefit in Patients with Hepatocellular Carcinoma in Phase III CheckMate -9DW Trial
Image credit: Crystal light | stock.adobe.com First-line combination immunotherapy with Opdivo (nivolumab) plus Yervoy (ipilimumab) achieved the primary endpoint of…
Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma
Image credit: catalin | stock.adobe.com Citius Pharmaceuticals, Inc. has resubmitted a biologics license application (BLA) to the FDA for Lymphir…
Phase III Trial Data Reinforce Potential of Imfinzi and Lynparza and Imfinzi Regimen for Endometrial Cancer
Image Credit: © LASZLO – stock.adobe.com Analysis of results from the DUO-E Phase III trial have reinforced the potential of…
SCRS Global Site Solutions Summit (9/27
SCRS Global Site Solutions Summit September 27-29, 2024 Hollywood, Florida https://sitesolutionssummit.com/ The Global Site Solutions Summit provides a unique hub…
Phase III Trial Data Show Meaningful Survival Improvements with Jemperli Combinations for Endometrial Cancer
Image credit: LASZLO | stock.adobe.com Survival data from the Phase III RUBY/ENGOT-EN6/GOG3031/NSGO trial demonstrated statistically significant and clinically meaningful outcomes…
PCM Trials Acquires EmVenio Research
Image Credit: © lidiia – stock.adobe.com PCM Trials has announced the acquisition of EmVenio Research, according to a press release.1…
Let’s Destroy Our Obsolete Paper Study Records
Image credit: sveta | stock.adobe.com The advent of electronic study records has dramatically slowed the growth of paper study records.…
Medical University of South Carolina and Flatiron Health Announce Collaboration
Image Credit: © tippapatt – stock.adobe.com Flatiron Health has announced a collaboration with the Medical University of South Carolina (MUSC),…
Is Drug Development More Aligned With Burden of Disease in the United States or Globally?
Image Credit: © peshkova – stock.adobe.com A study recently published in the British Medical Journal sought to evaluate the correlation…
Ethical Considerations for Collecting and Analyzing Patient Data with New Technologies
What ethical considerations need to be addressed when developing and implementing new technologies for collecting and analyzing patient data in…
Phase III KEYNOTE-A18 Trial Data Show Keytruda Plus Chemoradiotherapy Improves Overall Survival in High-Risk Cervical Cancer
Image credit: ibreakstock | stock.adobe.com Results from the Phase III KEYNOTE-A18 trial (NCT04221945) show that Merck’s Keytruda (pembrolizumab) plus chemoradiotherapy…
Personalizing the Trial Experience for Diverse Populations
How can new technologies personalize the clinical trial experience for diverse patient populations, considering factors like age, access to resources,…
Phase III THARROS Trial to Evaluate Impact of Breztri Aerosphere on Cardiopulmonary Outcomes in COPD
Image credit: Crystal light | stock.adobe.com AstraZeneca has announced plans to launch the Phase III THARROS trial to evaluate Breztri…
New Technologies Enhancing Transparency Between Patients and Researchers
How are you leveraging your background in digitalization and logistics in the development of new technologies to enhance communication and…
Merck Announces Clinical Trial Programs to Assess Novel Multi-Type HPV Vaccine, New Single-Dose Gardasil 9 Formulation
Image credit: Naeblys | stock.adobe.com Merck has announced multiple clinical trial programs seeking to develop a new multi-valent vaccine that…
A Need for Action
Mike Hennessy Jr, president and CEO, MJH Life Sciences® In recent years, Applied Clinical Trials has featured an issue theme…
New Legislation is Driving Diversity in Clinical Research
Rohit Nambisan, CEO and Co-Founder, Lokavant The scientific method is most effective when testing a hypothesis on data that best…
Yunu Co-founders Discuss the Future of Improving the Clinical Trial Imaging Landscape
ACT: Looking towards the future, what role do you see Yunu playing in further streamlining and improving the clinical trial…
eCOA Libraries: An untapped Opportunity?
Image Credit: © Sergey Nivens – stock.adobe.com The process of migrating translated and linguistically validated clinical outcome assessments (COAs) into…
Patient and Site Personnel Perceptions of Retail Pharmacy Involvement in Clinical Research
Image credit: Zamrznuti tonovi | stock.adobe.com During the past three years, retail pharmacies have entered the clinical research enterprise in…
Phase III DREAMM-8 Trial Shows Efficacy of Blenrep Combo Over Standard of Care for Relapsed/Refractory Multiple Myeloma
Image credit: freshidea | stock.adobe.com GSK’s Blenrep (belantamab mafodotin) combined with pomalidomide plus dexamethasone (PomDex) achieved the primary endpoint of progression-free…
Results From Phase II Study of Islatravir and Lenacapavir Combination Show Viral Suppression in Patients With HIV
Image Credit: © Ezume Images – stock.adobe.com Gilead Sciences and Merck have announced results from a Phase II clinical trial…
Yunu Co-Founders Talk Adapting to the Specific Needs of a Clinical Trial and Facilitating Reliable Imaging
ACT: How does your platform adapt to the specific needs and considerations of trials with cardiac, neuro, and pulmonary specialties…
Calling Out ‘Check-the-Box’ Patient Engagement
Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of…
Beyond the Iron Triangle: Behavioral Science Strategies
Brian S. McGowan, PhD, FACEHP,Chief Learning Officer and Co-Founder at ArcheMedX, Inc. The challenges with contemporary clinical trials are due…
Changing the Face—and Faces—of Clinical Research
Natalia Husby, Solutions Manager, Curavit Clinical Research Throughout history, clinical trials have often unintentionally marginalized the perspectives and experiences of…
Diversity in Clinical Trials: Strategies and Challenges
Jamie Harper, MHA, CCRP, Vice President, Site Solutions and Engagement, WCG The importance of diversity, equity, and inclusion (DE&I) within…
New Real-World Data Supports Use of Antiviral Therapy for Patients Hospitalized With COVID-19
Image Credit: © Production Perig – stock.adobe.com Gilead Sciences hast announced new data from three real-world retrospective studies involving its…
The Need to Take Action
Gadi Saarony, CEO of Advarra examines the current state of diversity in clinical research. He discusses the need for industry…
Four-Steps to Accelerate Study Start-up Cycles
Anusha Shetty, director, strategy, site startup, and engagement at Veeva Completing study start-up in clinical trials takes determination, coordination, and…
FDA Lifts Partial Clinical Hold on Phase II Trial of Novel Tumor Infiltrating Lymphocyte Cell Therapy for NSCLC
Image credit: Crystal light | stock.adobe.com The FDA has removed a partial clinical hold on a Phase II trial evaluating…
Analyzing Industry’s Current Perceptions of Parallel-Group Cluster-Randomized Trials
Image Credit: © Andrii Yalanskyi – stock.adobe.com A recent study published by the National Library of Medicine aimed to evaluate…
Results of Phase III Trial Show Promise of Potential First-in-Class Treatment for Dry Eye Disease
Image credit: herraez | stock.adobe.com A novel therapy for dry eye disease (DED) achieved clinically meaningful and statistically significant results…
UCB Seeks Approval of Bimzelx Across Multiple Indications Based on Favorable Trial Data
UCB has filed supplemental biologics license applications (sBLA) to the FDA for Bimzelx (bimekizumab-bkzx) across three new indications for psoriatic arthritis,…
Improving Diversity in Clinical Trials
A lack of diversity in clinical trials is a critical issue, as racial and ethnic subgroups may respond differently to…
Accelerating Time to Treatment in Rare Disease
Chris Moore, president, Veeva Europe Rare diseases aren’t actually rare. Every year, people’s lives are turned upside down by a…
Matching Adjusted Indirect Comparison of Trial Data Indicate Survival Advantage with Brukinsa Over Calquence for CLL
Image credit: Dr_Microbe | stock.adobe.com BeiGene’s Brukinsa (zanubrutinib) showed superiority to Calquence (acalabrutinib) in a matching adjusted indirect comparison (MAIC)…
Creating a Framework for Increased Accessibility in Palliative Care Research
Image Credit: © BillionPhotos.com – stock.adobe.com A recent study published by the National Library of Medicine has proposed a revised…
The Current State of Diversity in Randomized Clinical Trials for Peripheral Artery Disease
Image Credit: © Jakub Krechowicz – stock.adobe.com A recent study published by the National Library of Medicine reviewed diversity in…
Generational Differences Among African Americans, Their Experiences with the Healthcare System
Image credit: DC Studio | stock.adobe.com A large-scope research project outlined ahead identified and compared generational differences among African American…
Results of Phase II Clinical Trial Show Promise for Potential Obesity Treatment
Image Credit: © putilov_denis – stock.adobe.com Viking Therapeutics has announced positive top-line results from its Phase II clinical trial of…
Clinical Trial Matching Solutions: Understanding the Landscape
Image credit: Egor | stock.adobe.com The idea of using technology to find patients who meet the eligibility criteria for clinical…
FDA Grants Priority Review to Epkinly for Follicular Lymphoma Based on Data From Phase I/II EPCORE NHL-1 Trial
Image credit: Lisa | stock.adobe.com. The FDA has granted Priority Review status to a supplemental Biologics License Application (sBLA) filed…
Artificial Intelligence Drives Industry Response to Project Optimus
Image credit: Kaikoro | stock.adobe.com The FDA released its draft guidance in support of Project Optimus in January 2023. It…
FDA Reaches Agreement on Endpoints for Approval of Budiodarone for the Management of Atrial Fibrillation
Image Credit: © photon_photo – stock.adobe.com XYRA has announced that it has reached an agreement with FDA on the key…
GLP-1 Receptor Agonist Shows Significant Improvements in Treatment of Metabolic Dysfunction-Associated Steatohepatitis in Phase II Trial
Image credit: Rasi | stock.adobe.com Survodutide, Boehringer Ingelheim’s glucagon-like peptide-1 (GLP-1) receptor dual agonist, demonstrated what the company described as…
Advarra CEO Discusses Implementing Technology in Diverse Clinical Trials
ACT: It seems like AI is on everyone’s mind currently. How can AI along with some of the latest technology…
How AI is Changing Early Drug Development
Ramji Vasudevan, Senior Engineering Leader, Altimetrik Innovations in drug development lead to life-saving medicines that improve and extend people’s lives.…
Advarra CEO Discusses Improving Diversity In Clinical Trials
ACT: Where do you think industry currently is with improving diversity in clinical trials? Saarony: It’s not where it needs…
FDA Issues Cautionary Reminder to Medical Device Manufacturers Regarding Data Submitted from Third-Party Laboratories
Image Credit: Adobe Stock Images/tippapatt The FDA this week issued a warning to companies that manufacture medical devices regarding the…
Data from Phase III NOTUS and BOREAS Trials Lead to Priority Review of Dupixent for COPD
Image credit: peterschreiber.media | stock.adobe.com. The FDA has granted Priority Review status to a supplemental Biologics License Application (sBLA) submitted…
Therapeutic Vaccine for Chronic Hepatitis B Enters Clinical Trial
Image Credit: © photon_photo – stock.adobe.com Following 12 years of research, the first-in-human clinical trial of TherVacB, a therapeutic vaccine…
A Cross-Sectional Study of Patient Perspectives on Clinical Trial Participation in a Large Community-Based Research Facility
Image credit: Halfpoint | stock.adobe.com ABSTRACT We investigated patient perceptions of cancer clinical trials and the consent process through a…
ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial
Image Credit: © Aerial Mike – stock.adobe.com ImmunityBio has announced that enrollment and initial follow-up has been completed for the…
Worldwide Clinical Trials Expands Clinical Pharmacology Unit
Image Credit: © ipopba – stock.adobe.com Worldwide Clinical Trials has announced an expansion of the pharmacy at its Clinical Pharmacology…
First Subject Dosed in Phase I Clinical Trial of Investigational Protein Degrader for Neurodegenerative Disease
Image Credit: © putilov_denis – stock.adobe.com Arvinas has announced that the first subject was dosed in its Phase I clinical…
Phase III INDIGO Trial Data Lead to FDA Priority Review for Vorasidenib in IDH-Mutant Gliomas
Image credit: freshidea | stock.adobe.com. The FDA has granted Priority Review status to a New Drug Application (NDA) for vorasidenib,…
First Patient Randomized in Phase II Gene Therapy Trial for Congestive Heart Failure
Image Credit: © photon_photo – stock.adobe.com Bayer AG and Asklepios BioPharmaceutical (AskBio) announced that the first patient in the GenePHIT…
Navigating Evolving DEI Measures in Clinical Patient Recruitment: A Deep Dive
Image credit: Dzmitry | stock.adobe.com. Embarking on a journey through the ever-evolving landscape of clinical patient recruitment, it is important…
Colagen cu vitamina D3 – un beneficiu dublu pentru sănătatea oaselor și a pielii
un beneficiu dublu pentru sănătatea oaselor și a pielii Pe măsură ce îmbătrânim, nivelul de colagen al corpului scade în…
YPrime CEO, Jim Corrigan Speaks About the Company and Addressing Uncertainty in Clinical Trials
Applied Clinical Trials: Could you tell our audience a bit about YPrime? Jim Corrigan: First, thanks so much for having…
Citius Pharmaceuticals Resubmits Biologics License Application for Immunotherapy Following FDA’s Complete Response Letter
Image credit: Araki Illustrations | stock.adobe.com Citius Pharmaceuticals has resubmitted a biologics license application (BLA) to the FDA for Lymphir (denileukin…
Positive Evidence From TRILUMINATE Clinical Trial Leads to FDA Endorsement of Tricuspid Regurgitation Device
Image Credit: © Murrstock – stock.adobe.com Abbott has announced that an FDA advisory committee officially voted in favor of its…
Study Shows Potential of Predictive Modeling in Personalized Medicine
Image credit: photon_photo | stock.adobe.com. Researchers are beginning to realize the potential of artificial intelligence to predict the safety and…
FDA Upgrades Tepmetko to Full Approval for Metastatic NSCLC Based on VISION Trial Data
Image credit: iDoPixBox | stock.adobe.com. EMD Serono, Merck KGaA’s biopharmaceutical business, scored a traditional approval for Tepmetko (tepotinib) to treat…
Bridging the Recruitment Gap for Socioeconomically Disadvantaged Groups in Clinical Trials
Image credit: putilov_denis | stock.adobe.com It should not be surprising that clinical trials remain largely inaccessible to the vast majority…
Phase III OUtMATCH Trial Findings Lead to FDA Approval of Xolair to Treat Multiple Food Allergies
Image credit: bit24 | stock.adobe.com. The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the…
FDA Clears First Fingertip Pulse Oximeter for OTC Sale
Image Credit: Adobe Stock Images/New Africa Earlier this week, Masimo announced the FDA clearance of the MightySat Fingertip Pulse Oximeter,…
New Technology Springs Innovation in Clinical Trials Space
Image credit: dizain | stock.adobe.com. Many recognize that clinical trials can benefit from transformation–namely, digital transformation. For decades, various segments…
FDA Priority Review Granted to Augtyro for Solid Tumors Based on Phase I/II TRIDENT-1 Trial Data
Image credit: peterschreiber.media | stock.adobe.com. Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) has been granted Priority…
FDA Approves Aurlumyn as First Treatment for Severe Frostbite
Image credit: Szymon Bartosz | stock.adobe.com The FDA announced that it has officially approved Actelion Pharmaceuticals’ Aurlumyn (iloprost) injection, the…
Todd Everhart of Signant Health Discusses DCTs and Site Burden
Applied Clinical Trials: What have been some of the biggest changes you’ve noticed in the decentralized clinical trial (DCT) space…
Steve Young of CluePoints Discusses RBQM and Key Risk Indicators
ACT: Where do you think the industry currently is with adopting RBQM? Is there a growing level of comfort with…
Promising Phase II Trial Data Lead to FDA Fast Track Designation for Bepirovirsen to Treat Hepatitis B
Image credit: Destina | stock.adobe.com. The FDA has granted Fast Track designation to GSK’s novel antisense oligonucleotide (ASO) bepirovirsen to…
Beyond Can We…Where and When Should We?
Image Credit: Andy Studna A panel at the Summit for Clinical Ops (SCOPE) 2024 in Orlando, Florida discussed where industry…
New Collaboration Seeks to Accelerate Development of Antibody-Drug Conjugates
Image credit: Juan Gärtner | stock.adobe.com Samsung Biologics, a contract development and manufacturing organization (CDMO), and LegoChem Biosciences, a biotech…
Phase II Trial of Narcolepsy Treatment Shows Significant Improvements in Wakefulness
Image credit: ibreakstock | stock.adobe.com. The results of a Phase IIb trial for Takeda’s novel therapy for narcolepsy type 1…
Bringing AI Out of the Shadows and into the Physical World of Drug Development
Image credit: AndSus | stock.adobe.com. Artificial intelligence (AI) has been secretly controlling our digital world for decades. It curates our…
eCOA Flexibility in Clinical Trials: The Site Perspective
Image Credit: © Sergey Nivens – stock.adobe.com As medical product development drives advances in medical knowledge, clinical trials continue to…
15 ‘Shades’ of Change in Clinical Trial Start-Up and Execution
Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder at ArcheMedX, Inc. The No. 1 question I get from…
Vepdegestrant Granted FDA Fast Track Designation for ER-Positive/HER2-Negative Breast Cancer
Image credit: LASZLO | stock.adobe.com. The FDA has granted Fast Track designation to Arvinas’ and Pfizer’s vepdegestrant (ARV-471) monotherapy for…
Advancing Efforts to Reduce the Racial Gap in Clinical Research
Image credit: Prostock-studio | stock.adobe.com “Years ago, my aunt Sherri was diagnosed with breast cancer. Though she ultimately ended up…
Johnson & Johnson Reveals Promising Results from Clinical Trial Targeting Autoantibody-Driven Diseases
Image Credit: Adobe Stock Images/huenstructurebio.com Johnson & Johnson (J&J) has announced positive results from its clinical trials on nipocalimab, a…
Interim Analysis of DREAMM-7 Phase III Trial Shows Significant Survival Benefit With Blenrep in Multiple Myeloma
Image credit: LASZLO | stock.adobe.com Data from an interim analysis of the Phase III DREAMM-7 trial (NCT04246047) show that treatment…
Biosense Webster Announces Results From inspIRE and admIRE Clinical Trials
Image Credit: © photon_photo – stock.adobe.com Biosense Webster has announced late-breaking data from company-sponsored inspIRE and admIRE clinical trials, which…
Phase II NIPU Trial Data Lead to FDA Fast Track Designation for Cancer Vaccine in Mesothelioma Treatment
Mesothelial cells in body fluid sample. Image credit: toeytoey | stock.adobe.com The FDA has granted Fast Track Designation to Ultimovacs…
Takeda, Protagonist Partner to Advance Late-Stage Polycythemia Vera Drug
Image credit: Dr_Microbe | stock.adobe.com Takeda and Protagonist Therapeutics have entered a global license and collaboration agreement to develop and…
FDA Approves New Process to Accelerate CAR T-Cell Therapy Manufacturing
Image Credit: Adobe Stock Images/AIGen.com The FDA has approved a manufacturing process change that will result in a shorter manufacturing…
Phase II SPEARHEAD-1 Trial Data Lead to FDA Priority Review for Novel T-Cell Therapy
Image credit: MdBabul | stock.adobe.com The FDA has granted Priority Review status to Adaptimmune Therapeutics’ biologics license application (BLA) for…
FDA Fast Tracks Early Stage Novel Tumor-Infiltrating Lymphocyte Therapy
Image credit: Rasi | stock.adobe.com The FDA has granted Fast Track designation to Biosyngen’s BST02, a novel T-cell therapy for…
FDA Clears Investigational New Drug Application for Dual Oxyntomodulin Analog Agonist, DA-1726
Image Credit: © Aerial Mike – stock.adobe.com NeuroBo Pharmaceuticals has announced that the FDA has cleared its Investigational New Drug…
AstraZeneca Head of Immuno-Oncology and Gastrointestinal Tumors Franchise Discusses Key Phase III Trial Results in Hepatocellular Carcinoma
ACT: AstraZeneca recently announced positive results from its Phase 3 trial in patients with hepatocellular carcinoma (HCC) who are eligible…
Collaboration to Explore Clinical, Research Potential of Liquid Biopsy Platform
Image credit: Nathan Devery com | stock.adobe.com DELFI Diagnostics announced the official launch of its fragmentome-based research use only (RUO)…
Q&A With Peyton Howell, Chief Operating and Growth Officer, Parexel
Peyton Howell, Chief Operating and Growth Officer, Parexel At the 42nd annual J.P. Morgan Healthcare Conference which was recently held…
Phase III PERSEUS Trial Data Show Darzalex Faspro Combo Improves Survival in Newly Diagnosed Multiple Myeloma
Image credit: David A Litman | stock.adobe.com The FDA will evaluate Johnson & Johnson’s supplemental Biologics License Application (sBLA) for…
Combining Strategic Protocol Planning with Accurate Real-world Data
Image Credit: © Jakub Krechowicz – stock.adobe.com Sanofi has been partnering with TriNetX, a global health research network that propels…
FDA Fast Tracks First Clinical Stage RNA Exon Editor for Stargardt Disease
Image Credit: © Aerial Mike – stock.adobe.com Ascidian Therapeutics has announced that the FDA has cleared its investigational new drug…
Can Machine Learning be Efficient in Organizing Patient Safety Event Reports?
Image Credit: © Sergey Nivens – stock.adobe.com Patient safety event reports (PSEs) play an integral role in hospitals for keeping…
Phase II MOMENTUM Trial Shows Positive Findings Treating Duchenne Muscular Dystrophy
Image credit: luchschenF | stock.adobe.com Data from the Phase II MOMENTUM (Study SRP-5051-201) trial show a favorable risk-benefit profile for…
A New Horizon for Data Sharing with Truthful Statistics
Image Credit: © Egor – stock.adobe.com The need to preserve data quality, uphold transparency, and mitigate potential biases is underlined…
Biologics License Application for F8 Formulation of Tesamorelin Rejected by FDA
Image credit: RAJCREATIONZS | stock.adobe.com The FDA has issued a complete response letter (CRL) to Theratechnologies Inc. in response to…
FDA Approves New Drug Application to Expand Indication for Zynrelef
Credit: Heron Therapeutics, Inc The FDA has approved Heron Therapeutics, Inc’s supplemental New Drug Application (NDA) to expand the indication…
The Evolving Role of AI in Shifting the Bottleneck in Early Drug Discovery
Image credit: Tierney | stock.adobe.com The cost of drug discovery—the process of R&D that brings new drugs to patients to…
The Twists and Turns in Biopharma Dealmaking: 2024 Trends
Spikes and valleys in M&A and dealmaking activity have been fairly routine and expected occurrences over the years in the…
Standardizing Global Medicinal Product Documentation for Enhanced Patient Safety, Regulatory Efficiency in the Pharmaceutical Industry
Image credit: Mike Mareen | stock.adobe.com The pharmaceutical industry is characterized by a multitude of products with varying complexities and…
Micah Lieberman of ClinEco and CHI Speaks on the SCOPE Conference
Applied Clinical Trials: SCOPE Europe was held in Barcelona, Spain last October. Could you give our audience an overview of…
How to Improve Quality of Study Delivery? Work with Technology-enabled Sites
Image Credit: © photon_photo – stock.adobe.com While a lot has changed in the past five years in clinical research, the…
FDA Expands Indication for Dupixent in Eosinophilic Esophagitis to Include Children Under 12 Years
Image credit: Yurii Kibalnik | stock.adobe.com The FDA has approved an expanded indication for Regeneron Pharmaceuticals’ and Sanofi’s Dupixent (dupilumab) to treat…
Rare Disease Summit, 3/19-3/21/24
March 19-21, 2024 Philadelphia, PA Unite with the rare disease community to create powerful partnerships, advance orphan therapeutics and deliver…
Life Sciences Accounting & Reporting Congress, 3/26-3/28/24
March 26-28, 2024 Hilton at Penns Landing | Philadelphia, PA Access the Latest Intelligence, Accounting Reporting Standards, Regulatory Changes and…
Bringing the Clinical Trials Industry Together
Micah Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) shares the origin story of ClinEco…
Prilenia Announces Plans to Initiate Global Phase III Study of Novel ALS Treatment
Image Credit: © Aerial Mike – stock.adobe.com Prilenia Therapeutics B.V. has announced it will present clinical data supporting a future…
Early Phase Trial Shows Promise of CAR T-Cell Therapy for Pancreatic, Gastric Cancers
Image credit: AIGen | stock.adobe.com CARsgen Therapeutics Holdings Limited, an organization working with chimeric antigen receptor (CAR) T-cell therapies for…
Q&A with Fran Gregory, VP of Emerging Therapies, Cardinal Health
Fran Gregory, Vice President of Emerging Therapies at Cardinal Health What are some of the recent trends in the cell and…
FDA Grants Fast Track Designation to Novel BTK Inhibitor for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Image credit: LASZLO | stock.adobe.com The FDA has granted Fast Track Designation to Nurix Therapeutics, Inc’s investigational Bruton’s tyrosine kinase…
Novocure Files for PMA Based on Positive Phase III Trial Data for TTFields Therapy for Lung Cancer
Image credit: appledesign | stock.adobe.com The FDA has accepted Novocure’s premarket approval (PMA) application for the addition of tumor-treating fields…
Phase III Trial Data Show Significant Progression-Free Survival Benefit With Lutathera for GEP-NETs
Image credit: Design Cells | stock.adobe.com Phase III trial data for Novartis’ Lutathera (INN: lutetium [177Lu] oxodotreotide/USAN: lutetium Lu 177 dotatate)…
Q&A With Sofia Baig, President of Clinical Solutions at Precision for Medicine
Sofia Baig, President of Clinical Solutions at Precision for Medicine As clinical trial protocols have become more complex in recent…
Coming to Terms with Fair Market Value
Norman M. Goldfarb, Executive Director of the Site Council and Executive Director of the Clinical Research Interoperability Standards Initiative (CRISI)…
Balversa Approved by FDA for FGFR3+ Urothelial Carcinoma
Image credit: Matthieu | stock.adobe.com The FDA has approved Janssen’s Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial…
Evaluation of Different NLP Models for Parsing and Extraction of Clinical Data from Scientific Articles
Image credit: AREE | stock.adobe.com In the realm of medical research, the extraction of relevant clinical data from scientific articles…
Micah Lieberman of ClinEco Speaks on the Company’s Clinical Trials Ecosystem
Applied Clinical Trials: Could you tell our audience about ClinEco? Micah Lieberman: ClinEco is our new business. When I say,…
Cambridge Researchers Develop New Machine Learning Platform to Predict Chemical Reactions
Image Credit: Adobe Stock Images/catalin In collaboration with Pfizer, researchers from the University of Cambridge have created a platform called…
Hyqvia Approved by FDA to Prevent Chronic Inflammatory Demyelinating Polyneuropathy Relapse
Image credit: Chinnapong | stock.adobe.com The FDA has approved Takeda’s Hyqvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase]…
Phesi Releases Annual Analysis of Clinical Development for 2023
Image Credit: © ipopba – stock.adobe.com Phesi has released its annual global analysis of all clinical trials conducted in 2023.1…
Trial Data Show Efficacy of Zoryve Treating Atopic, Seborrheic Dermatitis
Image credit: chaphot | stock.adobe.com Arcutis Biotherapeutics recently shared significant findings from a pair of clinical trials showing the efficacy…
FDA Approves Keytruda Plus Chemoradiation for Stage III to IVA Cervical Cancer
Image credit: Aquir | stock.adobe.com The FDA has approved Merck’s Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients…
Scale Your Top Digital Stars in 2024—Not Just Generate New Ones
Jessica Jarvis and Daniel Blessing One prediction for 2024 that may go unnoticed but should not is that the top…
Former FDA Commissioner Gottlieb Outlines Strategies for Regulating Latest Medical Technologies
Image Credit: © Tierney – stock.adobe.com In a commentary published on the JAMA Forum, former FDA Commissioner Scott Gottlieb, MD,…
Early Phase Trial Results Lead to FDA Fast Track Designation for Acute Myeloid Leukemia Treatment
Image credit: LASZLO | stock.adobe.com The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor…
FDA Grants Clearance to ‘Pioneering’ Non-Invasive Treatment for Painful Diabetic Neuropathy
Image credit: AIGen | stock.adobe.com The FDA has granted clearance to Neuralace Medical’s Axon Therapy, which is a noninvasive treatment…
FDA Fast Tracks Ovarian Cancer Drug Currently in Phase II Trial
Image credit: blueringmedia | stock.adobe.com The FDA has granted Fast Track Designation (FTD) to RemeGen Co. Ltd’s mesothelin-targeting antibody-drug conjugate…
How Often are Registered Clinical Trials Publishing Their Results?
Image Credit: © FlowStudio – stock.adobe.com A commentary recently published on JAMA Network examined how often registered clinical trials are…
Putting Diversity at the Center of Clinical Trials With Real-World Data
Jen Lamppa, Associate Vice President, Clinical Analytics, Inovalon In the realm of clinical research, a highly selective process prevails that…
Recent Study on Multiple Sclerosis Identifies Biomarkers for Long-term Disability in Patients
Image Credit: © Aerial Mike – stock.adobe.com A recent study discovered a combination of 11 proteins that can predict long-term…
Microbiology is Vital to Compliance to Annex 1 and Risk-Based Regulation
Image credit: Yuliia | stock.adobe.com On November 23, 2023, the PDA Ireland Chapter hosted an event on Microbiology – The…
FDA to Evaluate New Drug Application for Unique Injectable Oncology Therapy
Image credit: Iryna | stock.adobe.com The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients…
Promising Trial Results Advance Lutikizumab to Phase III Study in Moderate to Severe Hidradenitis Suppurativa
Image credit: Kristina Blokhin | stock.adobe.com The results of a Phase II trial show that AbbVie’s lutikizumab (ABT-981) 300 mg…
A Discussion of Indegene’s New Study ‘Reshaping Pharmacovigilance in the Age of AI’ with Sameer Lal, Sr. Vice President, Enterprise Medical Solutions
Can you tell me about Indegene’s new study ‘Reshaping Pharmacovigilance in the Age of AI’? Sameer Lal: One part of…
FDA Accepts Biologics License Application for Novel PET Imaging Agent for Renal Cell Carcinoma
Image credit: Saiful52 | stock.adobe.com Telix Pharmaceuticals has filed a biologics license application (BLA) to the FDA for the novel…
Upping the Ante for Predicting the Success of Alzheimer Disease Treatments
Image credit: BillionPhotos.com | stock.adobe.com Over the past 20 years, less than a handful of completed Phase III Alzheimer disease…
Blenrep Shows Promise in DREAMM-7 Phase 3 Trial for Relapsed, Refractory Multiple Myeloma
DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib and dexamethasone…
FDA Warns of Rare But Serious Reaction to Antiseizure Medications
Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam; and clobazam,…
Promising Trial Data Lead to FDA Fast Track Designation for Breast Cancer Combination Therapy
FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative advanced or…
Combination of Keytruda Plus Padcev Gets FDA Priority Review for Urothelial Cancer
Supplemental Biologics License Application submission based on data from the Phase 3 KEYNOTE-A39 trial comparing Keytruda plus Padcev with chemotherapy…
Study Finds Low Representation of Disabled Participants in Cardiac Clinical Trials
Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design. A study recently published in the Journal…
Combining Awareness and Innovation
Published on: December 1, 2023 Jared Baeten, Vice President, Clinical Development, HIV Franchise Head at Gilead Sciences highlights how awareness and…