MedicalResearch.com offers the latest news, interviews, and insights in medical research, covering topics like a, cancer research, addiction, fitness and health.
Pharmaceutical Companies, Pharmacology / 02.05.2025

Effective Medicine Distribution Center   Running a medicine distribution center isn’t just about moving boxes from point A to point B. You’re dealing with products that save lives, so there’s no room for guesswork.  Every pill, vial, and package needs to be handled with care, tracked precisely, and delivered fast. You’ve got to think like a health worker, a warehouse manager, and a logistics expert—all at once.  If you mess up, people don’t get the meds they need. But when you do it right, you become a silent hero in the healthcare chain.  In this article, you’ll find smart, practical ways to run a distribution center that actually works—keeping meds safe, fresh, and on time, every time. 
  1. Optimize Your Inventory Management
You can’t run a smooth medicine center if you don’t know what’s on your shelves. Imagine getting an urgent order for insulin—only to realize you ran out last week. That’s a nightmare.  To avoid chaos, you need a smart inventory system that tracks every item in real time. Barcode scanners, digital dashboards, and simple forecasting tools can save your day—and your reputation. Set alerts for low stock, expiration dates, and fast-moving items.  Don’t let medicine collect dust or go to waste. Rotate stock regularly (first in, first out), and make room for incoming deliveries by keeping your shelves organized. If it feels like a game of Tetris, you’re doing it right.  The more you stay ahead of the numbers, the fewer emergencies you’ll face. And that means faster service, fewer headaches, and a smoother operation all around. Keep things tight, and your center will run like clockwork. (more…)
Pharmaceutical Companies, Pharmacology / 14.02.2025

Although each rare disease is uncommon on its own, together, they represent a major global health challenge. With over 7,000 known rare diseases, the global impact is substantial. Currently, around 300 million people worldwide are living with a rare disease.  Unlike more prevalent conditions, rare diseases often receive less research funding, making drug development a lengthy and challenging process. However, recent advancements in antibody drug discovery are transforming this landscape, offering new hope to millions of patients. Antibody drug discovery is an advanced biotechnology field that utilizes the immune system to develop precise treatments. Scientists identify and isolate specific antibodies capable of binding to disease-causing targets. This approach enables the creation of drugs that directly address the root cause of rare diseases, ensuring more effective and personalized therapies. In this article, we will explore the transformative impact of antibody drug discovery on rare disease research. 

Precision Targeting for Effective Treatment

A key advantage of antibody-based therapies is their ability to achieve precision targeting, which is essential for treating rare diseases. Since many rare diseases stem from genetic mutations or protein dysregulation, they are well-suited for highly specific and targeted interventions.  Antibodies can be designed to target disease-causing molecules like misfolded proteins, overactive receptors, or harmful cells while preserving healthy tissues. This precision improves treatment effectiveness and minimizes side effects, which is essential for patients with complex or fragile health conditions. To harness this potential, researchers are increasingly relying on advanced antibody discovery services. These services employ advanced technologies like phage display, single B-cell screening, and AI modeling to identify and refine high-affinity, specific antibodies for rare diseases. Partnering with specialized antibody discovery services helps researchers fast-track tailored therapies, offering hope to patients with untreatable conditions. This collaborative approach is revolutionizing rare disease research, leading to innovative treatments that target the root causes of complex disorders. Alloy Therapeutics recommends collaborating with an expert team to develop ranked bispecific candidates tailored to specific targets. Their comprehensive approach combines advanced technologies with proprietary workflows. This ensures the delivery of precise, high-quality bispecific leads for effective therapeutic development. (more…)
Laboratories, Medical Research Centers, Pharmaceutical Companies / 12.02.2025

Clinical trials are a fundamental part of medical research, ensuring the safety and efficacy of new drugs, medical devices, and treatments. A Clinical Research Organization (CRO) plays a pivotal role in managing and conducting these trials efficiently. From regulatory compliance to data management, CROs provide expertise that helps sponsors navigate the complexities of clinical research.

What is a Clinical Trials CRO?

A Clinical Research Organization (CRO) is a specialized service provider that assists pharmaceutical companies, biotech firms, and medical device manufacturers in conducting clinical trials. These organizations offer comprehensive services, including study design, patient recruitment, monitoring, regulatory compliance, data collection, and statistical analysis. CROs streamline the clinical trial process, reducing time and costs while ensuring compliance with regulatory authorities such as the FDA and EMA.

Key Services Offered by Clinical Trials CROs

  1. Protocol Development – Designing a scientifically sound and regulatory-compliant study protocol.
  2. Regulatory Compliance – Ensuring adherence to FDA, EMA, and other global regulatory requirements.
  3. Patient Recruitment and Management – Identifying and enrolling eligible patients for clinical trials.
  4. Site Selection and Monitoring – Identifying qualified research sites and ensuring compliance with Good Clinical Practice (GCP).
  5. Data Management and Biostatistics – Collecting, analyzing, and interpreting trial data.
  6. Safety Monitoring – Assessing adverse events and ensuring patient safety throughout the trial.
  7. Quality Assurance – Conducting audits and inspections to maintain data integrity and protocol adherence.
  8. Medical Writing and Reporting – Preparing regulatory submissions, study reports, and scientific publications.
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Pharmaceutical Companies / 08.02.2025

Pharmacovigilance and drug safety are critical aspects of the pharmaceutical industry, ensuring that medicines are both effective and safe for public use. At the heart of these efforts is regulatory writing, a specialized field that plays a vital role in documenting, analyzing, and communicating safety data to regulatory authorities. From clinical trial reports to post-marketing safety updates, regulatory writing helps pharmaceutical companies maintain compliance with global health regulations. Understanding Regulatory Writing in Pharmacovigilance Regulatory writing in pharmacovigilance involves the creation of structured, scientifically accurate, and regulatory-compliant documents. These documents serve multiple purposes, including reporting adverse events, assessing drug risk-benefit profiles, and maintaining transparency with regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global authorities. Pharmacovigilance documentation must adhere to strict guidelines such as ICH E2E (Pharmacovigilance Planning) and ICH E2C(R2) (Periodic Benefit-Risk Evaluation Reports), ensuring that pharmaceutical companies provide accurate and timely safety updates. (more…)
Hematology, Legal-Malpractice, Pharmaceutical Companies / 04.01.2025

Oxbryta, a groundbreaking treatment for sickle cell disease, brought hope to patients suffering from this debilitating condition. Approved by the FDA in 2019, the drug was designed to improve hemoglobin levels and reduce the painful complications associated with the disease. However, recent legal claims have sparked concern among patients and the pharmaceutical industry. Allegations surrounding the drug's safety and efficacy have led to a wave of lawsuits, potentially altering the landscape of sickle cell treatment. The emergence of Oxbryta injury lawsuits raises serious questions about the accountability of pharmaceutical companies and the adequacy of drug safety protocols. Patients who relied on Oxbryta to improve their quality of life now face uncertainty, with some alleging that the medication caused unexpected side effects or failed to deliver promised results. For many, these lawsuits represent a quest for justice and compensation for the harm endured, while for the broader healthcare industry, they highlight the critical need for transparency and rigorous testing. This article sheds light on the impact of Oxbryta lawsuits on patients and the pharmaceutical industry, addressing key concerns and implications for both parties. (more…)
Pharmaceutical Companies, Technology / 24.12.2024

1. The widespread use of machine learning

In recent years, we have seen the growing prevalence of generative artificial intelligence, as well as devices and platforms powered by machine learning. The healthcare sector isn’t spared from such disruptions as major brands and public institutions are harnessing AI to aid in conducting more accurate and ethical clinical tests and developing new drugs.    There’s no room for downplaying AI’s value to pharmaceutical research as it helps with analyzing molecular structures and patient data to come up with optimal formulations without compromising patient safety. While this would still require companies to tap into their existing knowledge bases, AI can help reduce the time it takes to formulate, test, and approve new products. 

2. Regulatory and ethical challenges remain

The emergence of generative AI in medical research doesn’t come without resistance coming from regulators. Considering that the technology is still at its most primitive despite its impressive capabilities, there is a growing need to enforce regulations addressing AI’s limitations and overreliance. Calls for greater equity in the pharmaceutical sector are also growing as stakeholders demand more affordable products.    The recent assassination of United Health CEO Brian Thompson highlights inequities that are also observed in the pharmaceutical industry, where quality vaccines and life-saving medication remain inaccessible to most low- and middle-income nations. Aside from this, there is also the need for companies to do their part in environmental protection by using technologies such as an effluent decontamination system for compliance and investing in sustainable manufacturing processes. (more…)
Author Interviews, JAMA, Pharmaceutical Companies / 11.10.2024

MedicalResearch.com Interview with:

David-Dan Nguyen MDCM MPH Doctoral Student Institute of Health Policy Management and Evaluation and Resident Physician Division of Urology University of Toronto

MedicalResearch.com: What is the background for this study? Response: Peer reviewers are crucial to the academic publishing process. While there’s been significant scrutiny of potential conflicts of interest among authors and editors of major journals, the potential for conflicts of interest among peer reviewers has been relatively unexplored. As such, our study aimed to quantify and characterize industry payments made to peer reviewers of top medical journals—The BMJ, JAMA, The Lancet, and The New England Journal of Medicine—to better understand the extent of these financial relationships.  (more…)
Pharmaceutical Companies / 25.04.2024

Introduction

pills-counterfeit-medicineThe pharmaceutical industry serves as a cornerstone in the healthcare systems of the United States and the European Union, ensuring the safety and efficacy of drugs is paramount. However, the rise of substandard or falsified drugs poses a significant threat to public health, challenging the regulatory and industry safeguards put in place. Understanding how these illicit products manage to circumvent the established systems is crucial for developing effective countermeasures.

Supply Chain Vulnerabilities

One of the primary avenues for substandard or falsified drugs to infiltrate the market is through weaknesses in the pharmaceutical supply chain. The intricate network of manufacturers, distributors, and retailers creates opportunities for unauthorized parties to introduce compromised products. In both the US and EU, regulatory bodies struggle to monitor every step of this expansive supply chain, making it susceptible to infiltration by counterfeiters. Globalization further complicates the issue, as pharmaceutical ingredients and finished products often cross international borders. The diversity of regulatory standards and enforcement capabilities worldwide allows substandard or falsified drugs to exploit regulatory gaps, entering the market through regions with weaker oversight. (more…)
Pharmaceutical Companies / 05.03.2024

In today's fast-paced society, advancements in technology, changes in patient demographics, and shifts in healthcare policies are continuously reshaping the role of pharmacists. To stay relevant and effective in your profession, it's essential to stay ahead of the curve and adapt to these emerging trends. Pharmacy TrendsAs a future pharmacist, you are positioned at the forefront of patient care, entrusted with ensuring the safe and effective use of medications. To fulfill this role effectively, you must remain informed and adaptable to the latest advancements in pharmacy practice. Before delving into these trends, let’s first look at some relevant statistics. With the industry witnessing constant evolution, the demand for pharmacists continues to soar even more. In the first three quarters of 2023, there were about 60,882 job postings for pharmacists. This marked an increase of 17.9% from 2022, indicating a significant push in demand for these professionals. The data from AACP’s Pharmacy Demand Report indicates that the time is opportune to enter the industry and gain a competitive edge. However, you must be aware of the prevalent trends to reap the benefits.  Utilizing free MPJE practice questions can also help you prepare effectively for your licensure exam. In this blog, we'll explore a few essential trends that every aspiring pharmacist should know. (more…)
Author Interviews, Mental Health Research, Pharmaceutical Companies / 14.01.2024

MedicalResearch.com Interview with: Lauren Davis Lauren C. Davis, MBS Department of Medical Education Geisinger Commonwealth School of Medicine Scranton, PA 19409   MedicalResearch.com: What is the background for this study? Response: Financial conflicts of interest (COIs) resulting from ties between academia and industry have been under scrutiny for their potential to hinder the integrity of medical research. COIs can lead to implicit bias, compromise the research process, and erode public trust (1-6). The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM), standardizes symptom criteria and codifies psychiatric disorders. This manual contributes to the approval of new drugs, extensions of patent exclusivity, and can influence payers and mental health professionals seeking third-party reimbursements. Given the implications of the DSM on public health, it is paramount that it is free of industry influence. Previous research has shown a high prevalence of industry ties among panel and task force members of the DSM-IV-TR and DSM-5, despite the implementation of a disclosure policy for the DSM-5 (7,8). This study (9) determined the extent and type of COIs received by panel and task-force members of the DSM-5-TR (2022) (10). As the DSM-5-TR did not disclose COI, we used the Center for Medicare and Medicaid Services Open Payments (OP) database (11) to quantify them. (more…)
Author Interviews, Moderna, NEJM, Pharmaceutical Companies, Respiratory, Vaccine Studies / 13.12.2023

MedicalResearch.com Interview with: Eleanor Wilson, M.D Moderna, 200 Technology Sq. Cambridge, MA 02139 MedicalResearch.com: What is the background for this study? What are the main findings and side effects (if any)? Response: The ConquerRSV trial is a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-associated lower respiratory tract disease (RSV-LRTD) defined as either two or more symptoms, or three or more symptoms of disease. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Most adverse reactions were mild to moderate in severity and included injection site pain, fatigue, headache, myalgia, and arthralgia. (more…)
Author Interviews, Eli Lilly, Gastrointestinal Disease / 03.11.2023

MedicalResearch.com Interview with: Lotus Mallbris, M.D., Ph.D., Senior Vice President of Immunology Development Eli Lilly MedicalResearch.com: Would you briefly describe the condition of Crohn's disease and who is most susceptible to this disease? Response: Crohn's disease is a form of inflammatory bowel disease (IBD) that can cause systemic inflammation manifested as abdominal pain, diarrhea, fever and weight loss. It can lead to intestinal obstruction, fibrosis and other complications. Approximately 900,000 patients in the U.S. and 1 million patients in Europe are currently suffering from Crohn’s disease, and 70% of those have moderate to severe disease. Although the majority of patients are started on conventional therapy such as corticosteroids and immunomodulators, many will unfortunately progress to having moderate to severe disease. Furthermore, current therapies to treat Crohn’s disease often fail to achieve remission for a majority of patients, and of the patients who do achieve remission, a substantial proportion lose it within the first year. (more…)
Author Interviews, Eli Lilly, Gastrointestinal Disease, NEJM / 02.11.2023

MedicalResearch.com Interview with: Marla C. Dubinsky, MD Professor of Pediatrics and Medicine Icahn School of Medicine at Mount Sinai Co- director, Susan and Leonard Feinstein IBD Clinical Center Mount Sinai Health System MedicalResearch.com: What is the background for this study? Would you briefly describe the condition of UC? Response: Lucent 1 and Lucent 2 were the induction and maintenance registration trials studying the efficacy and safety of mirikizumab in patients 18 years and older with moderate to severely active ulcerative colitis. Mirikizumab is a monoclonal antibody targeting the p19 subunit of IL23. Lucent-3 is the open label extension arm for those meeting inclusion criteria after completing Lucent 2. This study evaluated the long term efficacy and safety of mirikizumab in patients with ulcerative colitis who completed a total of 104 weeks of active mirikizumab treatment. Ulcerative colitis is a chronic incurable inflammatory condition of colon. Common symptoms include diarrhea, blood in the stool, abdominal cramping and bowel urgency. Bowel urgency is one of the most burdensome symptoms that a patient with you could experience. (more…)
Author Interviews, Dermatology, Eli Lilly, Immunotherapy / 18.05.2023

MedicalResearch.com Interview with: Lotus Mallbris, MD PhD Dermatologist andSenior Vice President Global Immunology Development and Medical Affairs  Lilly   MedicalResearch.com: What is the background for this study?  Would you briefly describe what is meant by atopic dermatitis and types treated in this study? Response: First, this study specifically evaluated lebrikizumab, a novel, investigational, monoclonal antibody that selectively binds to interleukin 13 (IL-13) with high-affinity and high potency. Inflammation due to over-activation of the IL-13 pathway plays a central role in the pathogenesis of moderate-to-severe atopic dermatitis, commonly called eczema. This secondary analysis focused on patients treated with lebrikizumab from the 16-week induction periods of the ADvocate 1 and ADvocate 2 studies and the ADhere study. In the trials, we assessed the presence or absence of face or hand dermatitis in patients with moderate-to-severe atopic dermatitis. If present at baseline, at 16 weeks, clinicians assessed the change from baseline on a scale of cleared, improved, no change, or worsened. Only patients with face and hand dermatitis were evaluated as part of the analysis. (more…)
Author Interviews, Genetic Research, Neurological Disorders, Novartis / 29.03.2023

MedicalResearch.com Interview with: Sitra Tauscher-Wisniewski, MD Vice President Clinical Development & Analytics Novartis Gene Therapies MedicalResearch.com: What is the background for this study? Would you briefly describe the condition of Spinal muscular atrophy (SMA)? Response: At the 2023 Muscular Dystrophy Association Conference, we presented new data from two of our  Long-Term Follow-Up (LTFU) studies, LT001 and LT002, which show the continued efficacy and durability of Zolgensma across a range of patient populations, with an overall benefit-risk profile that remains favorable. LT001 is a 15-year ongoing observational LTFU study following the Phase 1 START patients, who were the very first patients to receive our gene replacement therapy. LT-002 is a voluntary Phase 4 15-year ongoing follow-up safety and efficacy study of Zolgensma IV and investigational intrathecal (IT) OAV101 in patients previously treated in the Phase 3 IV studies (STR1VE-US, STR1VE-EU, STR1VE-AP, SPR1NT) and the Phase 1 IT study (STRONG). Spinal muscular atrophy (SMA) is a rare, devastating genetic disease that leads to progressive muscle weakness, paralysis, and when left untreated in one of its most severe forms (SMA Type 1), permanent ventilation or death in 90% of cases by age 2. It is caused by a lack of a functional survival motor neuron 1 (SMN1) gene, and in the most severe forms results in the rapid and irreversible loss of motor neurons, affecting muscle functions, including breathing, swallowing and basic movement. (more…)
Author Interviews, Dermatology, Eli Lilly, NEJM / 26.03.2023

MedicalResearch.com Interview with: Jonathan Silverberg, MD, PHD, MPH Professor Director of Clinical Research Director of Patch Testing George Washington University School of Medicine and Health Sciences Washington, DC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lebrikizumab was previously shown to be safe and effective as a treatment for moderate-severe atopic dermatitis in a phase 2 study. These Phase 3 randomized placebo-controlled trials are the largest studies to date of lebrikizumab in AD. They showed that lebrikizumab was safe and highly effective for the treatment of moderate-severe atopic dermatitis. These studies will hopefully support the approval of lebrikizumab in the United States later this year. (more…)
Author Interviews, Cost of Health Care, JAMA, Pharmaceutical Companies, Yale / 22.01.2023

MedicalResearch.com Interview with: Neeraj Patel Medical Student (MS-2), Yale School of Medicine New Haven, CT MedicalResearch.com: What is the background for this study? Response: Direct-to-consumer pharmaceutical advertising has been increasing in popularity for the past two decades or so, particularly via television. But it’s highly controversial. Only two high-income countries (the U.S. and New Zealand) widely permit this type of advertising for prescription drugs. Critics have pointed to a growing body of literature that suggests that direct-to-consumer advertising for prescription drugs can be misleading, lead to inappropriate prescribing, and inflate healthcare costs. Proponents have argued that it improves public health by promoting clinically beneficial prescribing. (more…)
Author Interviews, Biogen, NEJM, Rheumatology / 15.09.2022

MedicalResearch.com Interview with: Nathalie Franchimont, M.D., Ph.D. Senior Vice President, Head of Multiple Sclerosis and Immunology Head of the Multiple Sclerosis and Immunology Development Unit Biogen MedicalResearch.com: What is the background for this study? What are the main findings? Response: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects multiple organ systems. Rash and arthritis are among the most frequent manifestations of the disease and severe organ damage can also occur especially when organs like the kidney are affected. Litifilimab (known as BIIB059) is a monoclonal antibody being studied for the potential treatment of SLE and cutaneous lupus erythematosus (CLE). The Phase 2 LILAC study evaluated litifilimab versus placebo in two parts: Part A in participants who have SLE with active joint and skin manifestations; and Part B in participants with active CLE, including chronic and subacute subtypes, with or without other organ involvement. Results from the SLE portion of the study (Part A) show litifilimab met the study’s primary endpoint by significantly reducing total active joint count compared to placebo. Total active joint count was defined as the total number of tender or swollen joints. Litifilimab was generally well tolerated, with most reported adverse events (AEs) rated as mild or moderate. Note, this Phase 2 trial was not powered to assess secondary endpoints. Based on these positive Phase 2 results, Biogen is currently enrolling participants into the Phase 3 TOPAZ-1 and TOPAZ-2 studies, which will evaluate the efficacy and safety of litifilimab in participants with active SLE worldwide. Part B results from LILAC were published separately in NEJM on July 28, 2022 and expand the body of evidence supporting litifilimab as a potential first-in-class therapy for cutaneous lupus erythematosus in addition to SLE. (more…)
Author Interviews, Cost of Health Care, JAMA, Pharmaceutical Companies / 31.08.2022

MedicalResearch.com Interview with: Prof. Katharina Blankart, PhD Faculty of Economics and Business Administration University of Duisburg-Essen Essen, Germany MedicalResearch.com: What is the background for this study? Response: Given the high drug prices and policy discussions, we were interested whether the US may miss opportunities from medical innovation in availability of medicines compared to Germany. Since 2011, Germany has a unique way to determine value of new medicines after regulatory approval and to negotiate prices. We aimed to find out differences in availability of medicines in these two countries and timing of availability. We evaluated the differences in timing of availability and to characterize medicines not available to one of the two countries. (more…)
Author Interviews, Education, JAMA, Pharmaceutical Companies / 06.07.2022

MedicalResearch.com Interview with: SooYoung VanDeMark, MBS Geisinger Commonwealth School of Medicine Scranton, Pennsylvania MedicalResearch.com:  What is the background for this study?   Response: Health care providers utilize subscription-based, point-of-care databases such as DynaMed and UpToDate to provide clinical care guidance and remain current on the latest evidence-based findings. Both of these websites maintain this content through a cadre of physician contributors who write and edit articles for these sites. These physician contributors are required to self-report any conflicts of interest (COI) as outlined by the respective policies on each website. However, prior COI research into similarly self-regulated areas, such as medical and pharmacology textbooks, and clinical practice guidelines, has found both appreciable potential COI and inconsistencies between self-reported and industry mandated disclosures (1-3). This study (4) explored the accuracy of physician contributors to DynaMed and UpToDate by comparing their self-reported disclosure status with the financial remunerations they received from the healthcare industry (e.g., pharmaceutical companies) as reported to the U.S. Centers for Medicare and Medicaid Services’ Open Payments database. Physician contributors who reported “nothing to disclose” on their respective article topic but had an entry on Open Payments for having received money from industry, were classified as discordant and, thus, as having the potential for a COI. Additionally, total remuneration, gender, and payment category were investigated more in depth for each database. (more…)
Author Interviews, Cancer Research, Pharmaceutical Companies / 20.05.2022

MedicalResearch.com Interview with: Robert Wild, Ph.D Chief Scientific Officer Dracen Pharmaceuticals   MedicalResearch.com:  What is the background for the development of sirpiglenastat, i.e., would you briefly explain what is meant by glutamine antagonist? Response: Cancer cells consume and use glutamine for both energy generation and as a source of carbon and nitrogen for biomass accumulation. Many oncogenes and tumor suppressor genes drive large-scale metabolic reprogramming of tumors into glutamine addiction. These highly proliferating tumors create a hostile and immunosuppressive tumor microenvironment (TME), which is nutrient- depleted, acidic and hypoxic in nature. Sirpiglenastat (DRP-104), is a novel broad-acting glutamine antagonist that inhibits all 10 known glutamine metabolism enzymes. DRP-104 was designed to preferentially inhibit glutamine metabolism in tumors and associated TME and not in normal tissues, providing a large therapeutic window. DRP-104 demonstrates powerful direct apoptotic (cell death) properties and immune modulatory mechanisms through broad remodeling of the TME to infer DRP-104 impacts immune-metabolism. Inhibition of glutamine metabolism leads to:
  • Induction of apoptosis in glutamine-addicted tumor cells leading to substantial single-agent activity and tumor regressions
  • Rebalance of the TME that enhances immune cell infiltration and function
  • Differentiation and modulation of adaptive and innate immune cells toward a highly proliferative, activated and long-lived phenotype for a long-term durable response.
(more…)
Author Interviews, Boehringer Ingelheim, NEJM, Pulmonary Disease / 15.05.2022

MedicalResearch.com Interview with: Professor Luca Richeldi MD PhD Chair and Head, Division of Pulmonary Medicine Gemelli University Hospital - IRCCS Catholic University of the Sacred Heart Rome MedicalResearch.com:  What is the background for this study?  Would you briefly explain the condition of Idiopathic Pulmonary Fibrosis? Response: As you may know, Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible lung disease with high mortality. IPF is one of the more common forms of progressive fibrosing interstitial lung diseases and its symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. IPF is considered a “rare” disease, but it affects more than 3 million people worldwide. Currently, there are two approved antifibrotic drugs that slow, but do not stop, the progression of fibrosis. Therefore, there is a need for additional treatments that can be used alone or with existing antifibrotic therapies. Pre-clinical research indicated that phosphodiesterase 4 (PDE4) inhibition is associated with anti-inflammatory and antifibrotic effects that may be beneficial in patients with idiopathic pulmonary fibrosis. In this Phase 2, double-blind, placebo-controlled trial, we investigated the efficacy and safety of BI 1015550, an oral preferential inhibitor of the PDE4B subtype, in patients with IPF. Patients were randomly assigned in a 2:1 ratio to receive BI 1015550 at a dose of 18 mg twice daily or placebo. (more…)
Pharmaceutical Companies / 21.03.2022

medications-pharmaceuticals-drugsMedicine is now more widely available than ever before, and shelves are filling up with different drugs that have all sorts of impacts on the human body. Recent events such as the covid pandemic have shown how quickly new medicines can be developed and distributed throughout the world. The manufacturing process has been refined in a big way, and swift changes continue to be made on this front. However, if you were wanting to find out a bit more about how medicine is made, there is a lot to say on this particular front. Everything starts off in the initial development phase before a drug goes through its research and development, passes a number of checks and balances, and is eventually released into the wider world as a whole. So, let’s go into a little bit more detail about how medicine is actually made. (more…)
Alzheimer's - Dementia, Author Interviews, Eli Lilly, NEJM / 16.03.2021

MedicalResearch.com Interview with: Stephen Salloway, M.D., M.S. Director of Neurology and the Memory and Aging Program, Butler Hospital Martin M. Zucker Professor of Psychiatry and Human Behavior Professor of Neurology, Alpert Medical School of Brown University Providence, RI 02906  MedicalResearch.com: What is the background for this study? Response: This 78 week phase 2 study tested donanemab in patients with early Alzheimer’s disease. Donanemab is a an anti-amyloid monoclonal antibody that targets the N3 pyroglutamate epitope.  MedicalResearch.com: What are the main findings? Response: The drug produced a substantial lowering of amyloid plaques and showed a slowing in cognitive decline. Key innovations included using PET scans to ensure all patients were amyloid positive and had a moderate level of tau build-up and switching from drug to placebo once the amyloid level was below the expected cut-off for Alzheimer’s disease. There were no new safety signals. The main side-effect was amyloid-related imaging abnormalities (ARIA) that have been seen with other anti-amyloid treatments. ARIA is managed with regular safety MRI scans.  Donanemab is now being tested in a larger phase 3 trial that could lead to regulatory approval. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, Immunotherapy, Pharmaceutical Companies / 22.02.2021

MedicalResearch.com Interview with: https://www.inovio.com/Jeffrey Skolnik, MD Senior Vice President, Clinical Development INOVIO MedicalResearch.com: What is the background for this technology? Would you tell us a little about the brain tumor, Glioblastoma Multiforme? How common is it, whom does it primarily affect?  Response: Glioblastoma (GBM) is the most common malignant brain tumor, affecting more than 10 thousand people each year in the United States. Most people diagnosed with GBM are above the age of 60 years, although GBM can be diagnosed at any age, including in children and young adults. Despite decades of research, GBM remains almost universally fatal. GBM is a tumor of the glial cells of the brain, and current therapies are directed at removing tumor with surgery and killing residual tumor cells with radiation and chemotherapy. More recently, with the introduction of immunotherapies such as immune checkpoint inhibitors (ICI) for the treatment of cancer, clinical studies have tried to add this promising technology to the treatment of GBM. Unfortunately, despite success in other types of cancer, ICIs have not demonstrated any clinical benefit in treating GBM. Newer clinical studies aim at introducing a combination of newer therapies together to try to tackle this terrible disease, and INOVIO’s GBM-001 study is one such example of an innovative approach to treating GBM.    (more…)
Author Interviews, Infections, OBGYNE, Pharmaceutical Companies / 21.01.2021

MedicalResearch.com interview with: Dr. Stephen Brand, Chief Development Officer Mycovia Pharmaceuticals  Dr. Stephen Brand discusses the results of Mycovia’s three Phase 3 studies for recurrent vaginal yeast infections (RVVC )and what’s next for the company.  MedicalResearch.com: What is the background for these Phase 3 studies? Answer: Our Phase 3 clinical program for our oral therapy oteseconazole was comprised of three trials enrolling more than 870 patients at 176 sites across 11 different countries. Two of these trials, referred to as VIOLET were identical Phase 3 randomized, double-blind, placebo-controlled clinical trials to evaluate the safety of oteseconazole and its ability to prevent episodes of recurrent vulvovaginal candidiasis (RVVC), commonly referred to as chronic yeast infection. The trials took place over 48 weeks in subjects with an established disease history of at least three episodes of acute VVC in the past 12 months. More than 650 patients randomized at 125 sites across 11 countries. The VIOLET trials consisted of two parts: During the first part of the study which lasted two weeks after patients presented with an active VVC episode, patients were treated with three sequential 150mg doses of fluconazole. The second part consisted of 12 weeks, when the patient either took oteseconazole 150mg or a placebo once weekly (according to a random assignment), and then a 36-week follow-up period. In addition, subjects participating in the VIOLET trials in the U.S. who remained infection-free at their Week 48 visit were offered the opportunity to participate in an extension study and are being monitored for an additional 48 weeks to further define the long-term protection profile of oteseconazole. Eighty-five subjects are enrolled. The third Phase 3 study, called ultraVIOLET, was designed to complement and extend VIOLET as a 50-week randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of oteseconazole. In addition the study compared the effectiveness of oteseconazole compared to fluconazole, the current standard of care, to treat an acute VVC infection in the RVVC population. A total of 220 patients were randomized at 51 sites in the U.S. for the ultraVIOLET trial. The ultraVIOLET trial consisted of two parts: In the first part of the study RVVC subjects presenting with an active infection were randomized to receive either 2 days of dosing with oteseconazole or 3 sequential 150 mg doses of fluconazole (every 72 hours). The second part consisted of 11 weeks, when the patient took either oteseconazole or a placebo weekly (according to the random assignment from the first part of the study), and then a 37-week follow-up period. (more…)
Asthma, AstraZeneca, Author Interviews / 01.12.2020

MedicalResearch.com Interview with: Frank Trudo, MD MBA Vice President, US Medical, Respiratory & Immunology AstraZeneca  MedicalResearch.com: What is the background for this study? Response: PONENTE is a multicenter, open-label, single-arm, Phase IIIb trial to evaluate the efficacy and safety of reducing daily oral corticosteroids (OCS) use after initiation of 30 mg dose of FASENRA (benralizumab) administered subcutaneously in adult patients with severe eosinophilic asthma on high-dose inhaled corticosteroids plus long-acting beta2-agonist and long-term use of OCS therapy with or without additional asthma controller(s). The trial expands on OCS-sparing data previously seen in the ZONDA Phase III trial by using a faster steroid tapering schedule in patients who did not experience adrenal insufficiency to reduce OCS use from higher doses. Compared to published trials of other biologics, PONENTE has a personalized OCS tapering schedule that allows for more rapid OCS tapering from higher OCS doses, followed by an assessment of the adrenal function as part of decision-making to manage the risk of adrenal insufficiency. PONENTE also has a longer maintenance phase (approximately 24-32 weeks), allowing assessment of the durability of OCS reduction. FASENRA is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death). MedicalResearch.com: How is it administered?  Response: FASENRA is injected under your skin (subcutaneously) one time every 4 weeks for the first 3 doses, and then every 8 weeks. In 2019, FASENRA was approved in the US for self-administration in a single dose prefilled autoinjector, the FASENRA pen. (more…)
AstraZeneca, Author Interviews, Cancer Research, ESMO, Lung Cancer, NEJM, Yale / 08.10.2020

MedicalResearch.com Interview with: Roy S. Herbst, M.D., Ph.D. Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology Chief of Medical Oncology Yale Cancer Center and Smilow Cancer Hospital Associate Cancer Center Director for Translational Research Yale Cancer Center  MedicalResearch.com: What is the background for this study? How does osimertinib differ from prior versions of EGFR-TKI Inhibitors? o   ADAURA is a randomized, double-blinded, global and placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, and IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated. Patients were treated with osimertinib 80 mg once-daily oral tablets or placebo for three years or until disease recurrence. The primary endpoint is disease free survival (DFS) in Stage II and IIIA patients, and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. Osimertinib is not currently approved in the adjuvant setting in any country. o   Osimertinib is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. The results of the Phase III ADAURA trial of osimertinib demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer for patients. o   ADAURA results were first presented in May during the American Society of Clinical Oncology ASCO20 Virtual Scientific Program. (more…)