Category: Medicine

ACT: Where does the clinical research industry currently stand when it comes to integrating artificial intelligence (AI)? Stephen Pyke: Where are we seeing the uses […]

Image Credit: © Blue Planet Studio – stock.adobe.com The authors of a recent study published in Sage Journals conducted a cross-disciplinary review of 614 articles […]

Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing insights into treatment efficacy. Learn more about these exploratory […]

April 5th 2024 Article Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing insights into treatment efficacy. Learn […]

In the past decade, clinical trials have embraced new innovations, including digital technologies like wearables, eCOA, and eSource. These advancements generate vast amounts of data, […]

Image credit: yodiyim | stock.adobe.com Merck is launching a Phase III clinical trial to analyze the investigational therapy MK-1084 plus Keytruda (pembrolizumab) in certain patients […]

Real-world data (RWD) and real-world evidence (RWE) have become indispensable elements in the current clinical research scenario, intertwining seamlessly with traditional methodologies. Disease foundations are […]

Image Credit: © photon_photo – stock.adobe.com The first patient has been randomized in a Phase II clinical trial which is evaluating NBI-1070770 in adults with […]

Image Credit: © Murrstock – stock.adobe.com The Tufts Center for the Study of Drug Development (Tufts CSDD), in collaboration with CluePoints and PwC, has released […]

Image Credit: © iDoPixBox – stock.adobe.com Through a collaboration agreement with a large network of integrated, community-based oncology practices, Genprex has expanded the site network […]

Image Credit: © photon_photo – stock.adobe.com The first patient has been dosed in an open-label, dose-escalation Phase IIa clinical trial (NCT04496479) evaluating a first-in-class allogenic […]

ACT: What does the clinical research industry need to do better to recruit more underrepresented populations into their trials? Tirisham Gyang: The issue with clinical […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com A recent study published in the European Journal of Oncology Nursing (EJON) aimed to identify prominent trends in […]

ACT: What do you think has caused the lack of awareness when it comes to the recognition of MS in non-white populations? Tirisham Gyang: So […]

Image credit: ra2 studio | stock.adobe.com Of the technologies now widely used in clinical trials, electronic clinical outcomes assessments (eCOA) solutions are the most common […]

Image Credit: © putilov_denis – stock.adobe.com A commentary recently published in the Singapore Medical Journal examined opportunities for the application of artificial intelligence (AI) in […]

ACT: What should industry be keeping top of mind when it comes to designing and executing pain clinical trials? Greg Sturmer: I guess the first […]

ACT: Could you tell our audience a bit about O2P and its development journey? Greg Sturmer: O2P, another acronym. We’re an acronym rich industry. O2P […]

At the Veeva R&D and Quality Summit in Boston, Pharmaceutical Executive and Applied Clinical Trials spoke with three industry leaders who discussed their experiences pushing […]

ACT: Could you tell our audience a bit about O2P and its development journey? Greg Sturmer: When you look at the key features of O2P, […]

Image Credit: © photon_photo – stock.adobe.com Integrated research platform trials have recently generated more awareness in light of upcoming changes to the International Council for […]

Image credit: Dr_Microbe | stock.adobe.com Findings from the Phase III KRYSTAL-12 trial demonstrated that Krazati (adagrasib; Bristol Myers Squibb) monotherapy led to a survival benefit in […]

Image credit: Dmitry | stock.adobe.com A clinical trial is only as good as how well it is designed. For rare diseases or conditions, specifically, real-world […]

Image credit: klickit24 | stock.adobe.com Data from a Phase II trial (NCT04874350) showed promising topline findings for Lipocine Inc’s potential first in class therapy for […]

Image credit: pressmaster | stock.adobe.com The FDA has granted Fast Track designation (FTD) Johnson & Johnson’s nipocalimab to lower the risk of fetal neonatal alloimmune […]

Image Credit: © Sergey Nivens – stock.adobe.com A recent study published in JAMA Network Open aimed to determine whether postretraction citations of microRNA (mRNA) biomarker […]

Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about: Specific challenges women with chronic illnesses […]

Image credit: neirfy | stock.adobe.com Results from the Phase III NextCOVE (NCT05815498) trial demonstrated the efficacy of Moderna’s next-generation COVID-19 vaccine, mRNA-1283. Data show the […]

Image credit: WrightStudio | stock.adobe.com The complexity and number of clinical trials have significantly increased over the past 15 years. According to surveys for the […]

Image Credit: © iDoPixBox – stock.adobe.com In combination with chemotherapy, Tagrisso (osimertinib) has showed consistent benefit after disease progression in patients with locally advanced or […]

Associate Editor, Miranda Schmalfuhs, and uMotif’s Chief Product Officer, Julia Lakeland, discuss: What kinds of technologies can be developed to improve patient engagement and reduce […]

Beyond the data gap for pregnancy, what other specific challenges do women with chronic illnesses face when it comes to accessing appropriate treatment and participating […]

Image credit: Feng Yu | stock.adobe.com Many pitfalls are associated with clinical trials of pain therapeutics, accounting for disappointing study results over the past decade. […]

Image credit: ryanking999 | stock.adobe.com Biopharmaceutical companies developing vision-improving therapeutics are increasingly focused on drugs to target rare eye diseases. As a result, it is […]

Looking towards the future, what are your thoughts on the role of technology in addressing the data gap in women’s health research? Innovative digital technologies […]

Image Credit: © photon_photo – stock.adobe.com A study recently published on JAMA Network Open found that a group of randomized platform clinical trials were often […]

UCB’s Women of Childbearing Age Program is a commendable initiative. Can you tell me more about it and elaborate on some of the program’s most […]

Image Credit: © putilov_denis – stock.adobe.com Top-line data from the Phase II/III HEALEY amyotrophic lateral sclerosis (ALS) clinical trial showed a 13% improvement in function […]

Image Credit: © Blue Planet Studio – stock.adobe.com A study recently published in JAMA Network Open suggested a large language model (LLM) can be used […]

Image credit: Crystal light | stock.adobe.com First-line combination immunotherapy with Opdivo (nivolumab) plus Yervoy (ipilimumab) achieved the primary endpoint of overall survival (OS) in the […]

Image credit: catalin | stock.adobe.com Citius Pharmaceuticals, Inc. has resubmitted a biologics license application (BLA) to the FDA for Lymphir (denileukin diftitox-cxdl) to treat patients […]

Image Credit: © LASZLO – stock.adobe.com Analysis of results from the DUO-E Phase III trial have reinforced the potential of Imfinzi (durvalumab) plus platinum-based chemotherapy […]

SCRS West: Clinical Tech & Innovation Summit June 3-4, 2024 Scottsdale, Arizona https://www.scrswest.com/ Explore the potential of clinical technology at SCRS West – an exclusive […]

SCRS Global Site Solutions Summit September 27-29, 2024 Hollywood, Florida https://sitesolutionssummit.com/ The Global Site Solutions Summit provides a unique hub where sites, sponsors, CROs, and […]

Image Credit: © lidiia – stock.adobe.com PCM Trials has announced the acquisition of EmVenio Research, according to a press release.1 Effective immediately, the acquisition strengthens […]

Image credit: sveta | stock.adobe.com The advent of electronic study records has dramatically slowed the growth of paper study records. Nevertheless, there are probably millions […]

Image Credit: © tippapatt – stock.adobe.com Flatiron Health has announced a collaboration with the Medical University of South Carolina (MUSC), bringing its oncology support platform […]

Image Credit: © peshkova – stock.adobe.com A study recently published in the British Medical Journal sought to evaluate the correlation between FDA drug approvals from […]

Image credit: ibreakstock | stock.adobe.com Results from the Phase III KEYNOTE-A18 trial (NCT04221945) show that Merck’s Keytruda (pembrolizumab) plus chemoradiotherapy achieved the study’s primary endpoint […]

What ethical considerations need to be addressed when developing and implementing new technologies for collecting and analyzing patient data in clinical trials, while ensuring patient […]

Image credit: Crystal light | stock.adobe.com AstraZeneca has announced plans to launch the Phase III THARROS trial to evaluate Breztri Aerosphere—a single-inhaler, fixed-dose, triple-combination therapy—in […]

How can new technologies personalize the clinical trial experience for diverse patient populations, considering factors like age, access to resources, and cultural needs—while ensuring inclusivity […]

Image credit: Naeblys | stock.adobe.com Merck has announced multiple clinical trial programs seeking to develop a new multi-valent vaccine that will protect against multiple types […]

How are you leveraging your background in digitalization and logistics in the development of new technologies to enhance communication and transparency between patients and researchers […]

Rohit Nambisan, CEO and Co-Founder, Lokavant The scientific method is most effective when testing a hypothesis on data that best represents the population. While this […]

Mike Hennessy Jr, president and CEO, MJH Life Sciences® In recent years, Applied Clinical Trials has featured an issue theme in its editorial calendar solely […]

ACT: Looking towards the future, what role do you see Yunu playing in further streamlining and improving the clinical trial imaging landscape, and how is […]

Pamela Tenaerts, MD, Chief Scientific Officer, Medable Technology is a double-edged sword when it comes to increasing representativeness in clinical trials. When fully decentralized and […]

Image credit: Zamrznuti tonovi | stock.adobe.com During the past three years, retail pharmacies have entered the clinical research enterprise in earnest, offering decentralized approaches supporting […]

Image credit: freshidea | stock.adobe.com GSK’s Blenrep (belantamab mafodotin) combined with pomalidomide plus dexamethasone (PomDex) achieved the primary endpoint of progression-free survival (PFS) compared with standard […]

Image Credit: © Ezume Images – stock.adobe.com Gilead Sciences and Merck have announced results from a Phase II clinical trial evaluating the investigational combination of […]

Brian S. McGowan, PhD, FACEHP,Chief Learning Officer and Co-Founder at ArcheMedX, Inc. The challenges with contemporary clinical trials are due to the complexities of change […]

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine Listening to conversations and […]

ACT: How does your platform adapt to the specific needs and considerations of trials with cardiac, neuro, and pulmonary specialties compared to oncology trials? Sorenson: […]

Jamie Harper, MHA, CCRP, Vice President, Site Solutions and Engagement, WCG The importance of diversity, equity, and inclusion (DE&I) within clinical trials continues to be […]

Natalia Husby, Solutions Manager, Curavit Clinical Research Throughout history, clinical trials have often unintentionally marginalized the perspectives and experiences of minority groups, resulting in a […]

Image Credit: © Production Perig – stock.adobe.com Gilead Sciences hast announced new data from three real-world retrospective studies involving its antiviral therapy for patients hospitalized […]

Image credit: zinkevych | stock.adobe.com Zilebesiran achieved the primary endpoint of the Phase II KARDIA-2 study (NCT05103332) evaluating Roche’s and Alnylam’s novel RNA interference therapeutic […]

Anusha Shetty, director, strategy, site startup, and engagement at Veeva Completing study start-up in clinical trials takes determination, coordination, and continuous process improvement. The average […]

Image Credit: © putilov_denis – stock.adobe.com Elysium Therapeutics has announced positive results from a Phase I study (O2P-001) investigating the company’s proprietary Oral Overdose Protected […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com A recent study published by the National Library of Medicine aimed to evaluate researchers’ experiences with the trial […]

Image Credit: © Egor – stock.adobe.com NeuroBo Pharmaceuticals announced that it has received first site Institutional Review Board (IRB) approval to proceed with the Phase […]

Image credit: herraez | stock.adobe.com A novel therapy for dry eye disease (DED) achieved clinically meaningful and statistically significant results in the pivotal Phase III […]

UCB has filed supplemental biologics license applications (sBLA) to the FDA for Bimzelx (bimekizumab-bkzx) across three new indications for psoriatic arthritis, non-radiographic axial spondylarthritis, and ankylosing […]

A lack of diversity in clinical trials is a critical issue, as racial and ethnic subgroups may respond differently to therapies, potentially undermining efficacy and […]

Chris Moore, president, Veeva Europe Rare diseases aren’t actually rare. Every year, people’s lives are turned upside down by a diagnosis of one of 10,000 […]

Image credit: Dr_Microbe | stock.adobe.com BeiGene’s Brukinsa (zanubrutinib) showed superiority to Calquence (acalabrutinib) in a matching adjusted indirect comparison (MAIC) evaluating the efficacy of these […]

Image Credit: © BillionPhotos.com – stock.adobe.com A recent study published by the National Library of Medicine has proposed a revised framework for increasing accessibility to […]

Image credit: DC Studio | stock.adobe.com A large-scope research project outlined ahead identified and compared generational differences among African American adults and their experiences with […]

Image Credit: © Jakub Krechowicz – stock.adobe.com A recent study published by the National Library of Medicine reviewed diversity in randomized clinical trials (RCTs) for […]

Image credit: Egor | stock.adobe.com The idea of using technology to find patients who meet the eligibility criteria for clinical trials sounds straightforward. A patient […]

Image Credit: © putilov_denis – stock.adobe.com Viking Therapeutics has announced positive top-line results from its Phase II clinical trial of VK2735, a potential therapy for […]

Image credit: Lisa | stock.adobe.com. The FDA has granted Priority Review status to a supplemental Biologics License Application (sBLA) filed by Genmab A/S and AbbVie […]

Image credit: Kaikoro | stock.adobe.com The FDA released its draft guidance in support of Project Optimus in January 2023. It offers clear direction for industry […]

Image Credit: © photon_photo – stock.adobe.com XYRA has announced that it has reached an agreement with FDA on the key studies that will form the […]

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 “groundbreaking” results in the treatment […]

Ramji Vasudevan, Senior Engineering Leader, Altimetrik Innovations in drug development lead to life-saving medicines that improve and extend people’s lives. Bringing a new drug to […]

Image credit: Halfpoint | stock.adobe.com ABSTRACT We investigated patient perceptions of cancer clinical trials and the consent process through a 13-year cross-sectional study involving 340 […]

ACT: Where do you think industry currently is with improving diversity in clinical trials? Saarony: It’s not where it needs to be. I say this […]

Image Credit: Adobe Stock Images/tippapatt The FDA this week issued a warning to companies that manufacture medical devices regarding the quality of data submitted from […]

Image Credit: © photon_photo – stock.adobe.com Following 12 years of research, the first-in-human clinical trial of TherVacB, a therapeutic vaccine for the treatment of hepatitis […]

Image credit: peterschreiber.media | stock.adobe.com. The FDA has granted Priority Review status to a supplemental Biologics License Application (sBLA) submitted by Regeneron Pharmaceuticals and Sanofi […]

Image Credit: © Aerial Mike – stock.adobe.com ImmunityBio has announced that enrollment and initial follow-up has been completed for the safety portions of a cancer […]

Image Credit: © Egor – stock.adobe.com NeuroSense Therapeutics has announced the reporting of additional positive data from its Phase IIb PARADIGM trial of NeuroSense’s lead […]

Image Credit: © putilov_denis – stock.adobe.com Arvinas has announced that the first subject was dosed in its Phase I clinical trial of ARV-102, according to […]

Image Credit: © ipopba – stock.adobe.com Worldwide Clinical Trials has announced an expansion of the pharmacy at its Clinical Pharmacology Unit (CPU) in San Antonio, […]

Image Credit: © photon_photo – stock.adobe.com Bayer AG and Asklepios BioPharmaceutical (AskBio) announced that the first patient in the GenePHIT (Gene PHosphatase Inhibition Therapy) clinical […]

Image credit: freshidea | stock.adobe.com. The FDA has granted Priority Review status to a New Drug Application (NDA) for vorasidenib, Servier’s targeted therapy for isocitrate […]

Applied Clinical Trials: Could you tell our audience a bit about YPrime? Jim Corrigan: First, thanks so much for having time here. It’s great to […]

Image credit: Dzmitry | stock.adobe.com. Embarking on a journey through the ever-evolving landscape of clinical patient recruitment, it is important to understand the intricacies of […]

Image Credit: © Murrstock – stock.adobe.com Abbott has announced that an FDA advisory committee officially voted in favor of its TriClip System, designed to address […]

Image Credit: Adobe Stock Images/New Africa Earlier this week, Masimo announced the FDA clearance of the MightySat Fingertip Pulse Oximeter, representing the first FDA-cleared fingertip […]

Image credit: photon_photo | stock.adobe.com. Researchers are beginning to realize the potential of artificial intelligence to predict the safety and efficacy of drugs across different […]

Image credit: iDoPixBox | stock.adobe.com. EMD Serono, Merck KGaA’s biopharmaceutical business, scored a traditional approval for Tepmetko (tepotinib) to treat adults with metastatic non–small cell […]

Image credit: bit24 | stock.adobe.com. The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the first medication indicated to reduce […]

Image credit: putilov_denis | stock.adobe.com It should not be surprising that clinical trials remain largely inaccessible to the vast majority of patients in the United […]

Image credit: dizain | stock.adobe.com. Many recognize that clinical trials can benefit from transformation–namely, digital transformation. For decades, various segments of this domain were unchanged. […]

Image credit: peterschreiber.media | stock.adobe.com. Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) has been granted Priority Review status by the FDA […]

Image credit: Szymon Bartosz | stock.adobe.com The FDA announced that it has officially approved Actelion Pharmaceuticals’ Aurlumyn (iloprost) injection, the first treatment cleared for severe […]

Image credit: Matthieu | stock.adobe.com. The FDA has approved Ipsen’s Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) for the first-line […]

ACT: Where do you think the industry currently is with adopting RBQM? Is there a growing level of comfort with it? Young: The short answer […]

Helen Yeardley, Senior Vice President, Global Clinical Operations, ICON plc The role of the clinical research associate (CRA) is fundamentally important to the success of […]

Image Credit: Andy Studna A panel at the Summit for Clinical Ops (SCOPE) 2024 in Orlando, Florida discussed where industry currently is with utilizing generative […]

Image credit: Matthieu | stock.adobe.com. The FDA has approved Takeda’s Eohilia (budesonide oral suspension) for the treatment of patients aged 11 years and older with […]

Image credit: Juan Gärtner | stock.adobe.com Samsung Biologics, a contract development and manufacturing organization (CDMO), and LegoChem Biosciences, a biotech company, announced a partnership focused […]

Image credit: ibreakstock | stock.adobe.com. The results of a Phase IIb trial for Takeda’s novel therapy for narcolepsy type 1 (NT1) produced statistically significant and […]

Image credit: AndSus | stock.adobe.com. Artificial intelligence (AI) has been secretly controlling our digital world for decades. It curates our online searches, understands our virtual […]

Image Credit: © Sergey Nivens – stock.adobe.com As medical product development drives advances in medical knowledge, clinical trials continue to become increasingly complex, potentially adding […]

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder at ArcheMedX, Inc. The No. 1 question I get from clinical research professionals who have […]

Image credit: Daniel Krasoń | stock.adobe.com Amgen’s novel weight loss drug candidate maridebart cafraglutide (MariTide) showed significant promise in a Phase I trial (NCT04478708), with […]

Image credit: Prostock-studio | stock.adobe.com “Years ago, my aunt Sherri was diagnosed with breast cancer. Though she ultimately ended up beating it, the challenges she […]

Image credit: LASZLO | stock.adobe.com. The FDA has accepted a pair of regulatory submissions for Bristol Myers Squibb’s Opdivo (nivolumab) plus chemotherapy followed by surgery and […]

Image credit: LASZLO | stock.adobe.com Data from an interim analysis of the Phase III DREAMM-7 trial (NCT04246047) show that treatment with GSK’s Blenrep (belantamab mafodotin) combined […]

Venkatraman “Bala” Balasubramanian, PhD, Senior VP and Global Head of HLS Orion Innovation Large Language Models (LLMs) are the foundation behind GenAI and have become the topic […]

Mesothelial cells in body fluid sample. Image credit: toeytoey | stock.adobe.com The FDA has granted Fast Track Designation to Ultimovacs ASA’s novel cancer vaccine UV1, […]

Kostja Paschalidis, service design lead, Beyond Estelle Ricoux, director of product and strategy for Europe, Beyond Every day, new advancements are being made in the […]

Image Credit: Adobe Stock Images/AIGen.com The FDA has approved a manufacturing process change that will result in a shorter manufacturing time for Yescarta, Kite’s branded […]

Image credit: MdBabul | stock.adobe.com The FDA has granted Priority Review status to Adaptimmune Therapeutics’ biologics license application (BLA) for afamitresgene autoleucel (afami-cel) in the […]

Image credit: Rasi | stock.adobe.com The FDA has granted Fast Track designation to Biosyngen’s BST02, a novel T-cell therapy for all types of liver cancer, […]

Image Credit: © Aerial Mike – stock.adobe.com NeuroBo Pharmaceuticals has announced that the FDA has cleared its Investigational New Drug (IND) application for DA-1726, a […]

ACT: AstraZeneca recently announced positive results from its Phase 3 trial in patients with hepatocellular carcinoma (HCC) who are eligible for embolization at ASCO GI. […]

Image credit: Nathan Devery com | stock.adobe.com DELFI Diagnostics announced the official launch of its fragmentome-based research use only (RUO) cancer monitoring assay, the DELFI-Tumor […]

Peyton Howell, Chief Operating and Growth Officer, Parexel At the 42nd annual J.P. Morgan Healthcare Conference which was recently held January 8-11, 2024, Parexel and […]

Image credit: David A Litman | stock.adobe.com The FDA will evaluate Johnson & Johnson’s supplemental Biologics License Application (sBLA) for Darzalex Faspro (daratumumab and hyaluronidase-fihj) with […]

Image Credit: © Jakub Krechowicz – stock.adobe.com Sanofi has been partnering with TriNetX, a global health research network that propels clinical research and empowers scientific […]

ACT: As we transition into this new year, there’s a lot of talk about AI, technology, multiple data sources, etc. in clinical trials. It seems […]

Image Credit: © Sergey Nivens – stock.adobe.com Patient safety event reports (PSEs) play an integral role in hospitals for keeping accurate records of adverse events […]

Image credit: Saiful52 | stock.adobe.com The FDA has approved Takeda’s intravenous immunoglobulin Gammagard Liquid [immune globulin infusion (human) 10% solution] for the treatment of neuromuscular disability […]

Image Credit: © Egor – stock.adobe.com The need to preserve data quality, uphold transparency, and mitigate potential biases is underlined by new challenges of managing […]

Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s […]

Credit: Heron Therapeutics, Inc The FDA has approved Heron Therapeutics, Inc’s supplemental New Drug Application (NDA) to expand the indication of Zynrelef (bupivacaine and meloxicam) extended-release […]

Image credit: Tierney | stock.adobe.com The cost of drug discovery—the process of R&D that brings new drugs to patients to address unmet medical needs—has grown […]

Spikes and valleys in M&A and dealmaking activity have been fairly routine and expected occurrences over the years in the biopharmaceutical sector. Just when they’ll […]

Image credit: Mike Mareen | stock.adobe.com The pharmaceutical industry is characterized by a multitude of products with varying complexities and properties, each designed to improve […]

Applied Clinical Trials: SCOPE Europe was held in Barcelona, Spain last October. Could you give our audience an overview of that? Micah Lieberman: SCOPE Europe […]

Image Credit: © photon_photo – stock.adobe.com While a lot has changed in the past five years in clinical research, the most common findings from Food […]

Image credit: Yurii Kibalnik | stock.adobe.com The FDA has approved an expanded indication for Regeneron Pharmaceuticals’ and Sanofi’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in patients […]

March 19-21, 2024 Philadelphia, PA Unite with the rare disease community to create powerful partnerships, advance orphan therapeutics and deliver life-changing breakthroughs. The Rare Disease […]

March 26-28, 2024 Hilton at Penns Landing | Philadelphia, PA Access the Latest Intelligence, Accounting Reporting Standards, Regulatory Changes and Transformational Strategies to Advance Your […]

Micah Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) shares the origin story of ClinEco and why he felt the […]

Image Credit: © Aerial Mike – stock.adobe.com Prilenia Therapeutics B.V. has announced it will present clinical data supporting a future Phase III study of the […]

Image credit: AIGen | stock.adobe.com CARsgen Therapeutics Holdings Limited, an organization working with chimeric antigen receptor (CAR) T-cell therapies for the treatment of hematologic malignancies […]

Fran Gregory, Vice President of Emerging Therapies at Cardinal Health What are some of the recent trends in the cell and gene therapy space? This is […]

Image credit: LASZLO | stock.adobe.com The FDA has granted Fast Track Designation to Nurix Therapeutics, Inc’s investigational Bruton’s tyrosine kinase (BTK) inhibitor NX-5948 for adults […]

Image credit: appledesign | stock.adobe.com The FDA has accepted Novocure’s premarket approval (PMA) application for the addition of tumor-treating fields (TTFields) to standard-of-care (SOC) therapies […]

Image credit: Design Cells | stock.adobe.com Phase III trial data for Novartis’ Lutathera (INN: lutetium [177Lu] oxodotreotide/USAN: lutetium Lu 177 dotatate) show first-line therapy with the […]

Sofia Baig, President of Clinical Solutions at Precision for Medicine As clinical trial protocols have become more complex in recent years, institutions are facing new […]

Norman M. Goldfarb, Executive Director of the Site Council and Executive Director of the Clinical Research Interoperability Standards Initiative (CRISI) “Fair market value” (FMV) can […]

Image credit: Matthieu | stock.adobe.com The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease […]

Image credit: AREE | stock.adobe.com In the realm of medical research, the extraction of relevant clinical data from scientific articles is a critical yet challenging […]

Applied Clinical Trials: Could you tell our audience about ClinEco? Micah Lieberman: ClinEco is our new business. When I say, “our,” I mean SCOPE, CHI; […]

Image credit: Chinnapong | stock.adobe.com The FDA has approved Takeda’s HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] as a maintenance therapy to […]

Image Credit: Adobe Stock Images/catalin In collaboration with Pfizer, researchers from the University of Cambridge have created a platform called the chemical reactome that combines […]

Image Credit: © ipopba – stock.adobe.com Phesi has released its annual global analysis of all clinical trials conducted in 2023.1 Using data from its Trial […]

Image credit: chaphot | stock.adobe.com Arcutis Biotherapeutics recently shared significant findings from a pair of clinical trials showing the efficacy of Zoryve (roflumilast) for the […]

Image credit: Aquir | stock.adobe.com The FDA has approved Merck’s Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III […]

Jessica Jarvis and Daniel Blessing One prediction for 2024 that may go unnoticed but should not is that the top players in pharma will begin […]

Image Credit: © Tierney – stock.adobe.com In a commentary published on the JAMA Forum, former FDA Commissioner Scott Gottlieb, MD, recalls the lessons he learned […]

Image credit: LASZLO | stock.adobe.com The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of […]

Image credit: AIGen | stock.adobe.com The FDA has granted clearance to Neuralace Medical’s Axon Therapy, which is a noninvasive treatment for chronic pain related to […]

Jen Lamppa, Associate Vice President, Clinical Analytics, Inovalon In the realm of clinical research, a highly selective process prevails that favors patients with the financial […]

Image credit: blueringmedia | stock.adobe.com The FDA has granted Fast Track Designation (FTD) to RemeGen Co. Ltd’s mesothelin-targeting antibody-drug conjugate (ADC) RC88 to treat patients […]

Image Credit: © FlowStudio – stock.adobe.com A commentary recently published on JAMA Network examined how often registered clinical trials are publishing their results.1 The cross-sectional […]

Image Credit: © Aerial Mike – stock.adobe.com A recent study discovered a combination of 11 proteins that can predict long-term disability in patients with multiple […]

Image credit: Yuliia | stock.adobe.com On November 23, 2023, the PDA Ireland Chapter hosted an event on Microbiology – The Key to Compliance with Annex […]

Image credit: Kristina Blokhin | stock.adobe.com The results of a Phase II trial show that AbbVie’s lutikizumab (ABT-981) 300 mg every other week or 300 […]

Image credit: Iryna | stock.adobe.com The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. […]

Can you tell me about Indegene’s new study ‘Reshaping Pharmacovigilance in the Age of AI’? Sameer Lal: One part of my business is very focused […]

Image credit: Saiful52 | stock.adobe.com Telix Pharmaceuticals has filed a biologics license application (BLA) to the FDA for the novel positron emission tomography (PET) imaging […]

Image credit: BillionPhotos.com | stock.adobe.com Over the past 20 years, less than a handful of completed Phase III Alzheimer disease (AD) clinical trials have been […]

Pirtobrutinib (Jaypirca) is a next-generation, highly selected, non-covalent BTK inhibitor that has shown nanomolar potency against wild-type and C481-mutant BTK in cell and enzyme assays. […]

KRP203 (mocravimod) is intended to improve outcomes after hematopoietic stem cell transplantation for the treatment of hematologic malignancies. Priothera Ltd. has announced that the FDA […]

DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib and dexamethasone in patients with relapsed/refractory multiple […]

FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative advanced or metastatic breast cancer. The FDA […]

Supplemental Biologics License Application submission based on data from the Phase 3 KEYNOTE-A39 trial comparing Keytruda plus Padcev with chemotherapy of gemcitabine plus cisplatin or […]

Published on: December 1, 2023 Jared Baeten, Vice President, Clinical Development, HIV Franchise Head at Gilead Sciences highlights how awareness and clinical innovation have transformed research […]

Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design. A study recently published in the Journal of the American Heart Association […]

Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam; and clobazam, under the brand names Onfi […]

Arcutis Biotherapeutics’ supplemental new drug application was supported by significant findings from a trio of Phase 3 trials, a Phase 2 dose ranging trial, and […]

Data from the EMERGENT clinical trial program show Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) produced statistically significant and clinically meaningful improvements in the symptoms of schizophrenia. […]

Patient-first trial design, based around the tenets of adaptability and personalization, has emerged as a key solution to increase diversity and improve trial outcomes for […]

The Elecsys HBeAg quant can detect the presence and quantity of the hepatitis B e antigen (HBeAg) in human serum and plasma. Roche has launched […]

Results from decade-long analysis suggest great improvement is needed in the quality of control groups. A study recently posted in JAMA Network Open examined the […]