Allergies, Author Interviews, Dermatology / 06.12.2025

[caption id="attachment_71677" align="alignleft" width="200"]Dr. Shaila Gogate, MDColorado Allergy & Asthma Centers Allergist REMIX-1/-2 Investigator  Dr. Gogate[/caption] MedicalResearch.com Interview with: Dr. Shaila Gogate, MD Colorado Allergy & Asthma Centers Allergist REMIX-1/-2 Investigator MedicalResearch.com: What is the background for this study? What are the main findings? A: The Phase III REMIX-1/-2 studies were randomized, double-blind, placebo-controlled studies assessing the efficacy and safety of oral  remibrutinib 25 mg twice daily or placebo over a 24-week double-blind period, followed by a 28-week open-label remibrutinib treatment period. The purpose of this pooled analysis was to examine the early and long-term efficacy data of remibrutinib vs. placebo over time, looking at the mean percentage change from baseline (CFB) in weekly scores of disease activity (UAS7), itch severity (ISS7) and hives severity (HSS7) over 52 weeks. This analysis demonstrated that remibrutinib showed reductions in urticaria symptoms vs. placebo as early as week 1:
    • 38.4% vs. 10.3% in UAS7
    • 37.0% vs. 9.8% in ISS7
    • 39.8% vs. 10.1% HSS7 Greater reductions vs. placebo were seen over 24 weeks and results were observed in the open-label period through week 52 in all remibrutinib-treated patients (including those transitioned from placebo).
Author Interviews, Heart Disease, Pharmacology / 05.11.2025

In medicine, we often picture massive, straight-line progress: hypothesis to experiment to result. But the truth is, many of the greatest leaps forward start with something much smaller—an unexpected signal, a moment of deep curiosity, or what scientists playfully call a "blip". That’s exactly how the groundbreaking story of XXB750 began. In a Novartis research lab, scientists noticed a subtle irregularity in the data—something that simply didn't fit their expectations. The easy thing would have been to ignore it, to write it off as an error. Instead, they decided to dig deeper. That single decision, driven by curiosity, is what led to a potential new therapy for heart failure and resistant hypertension—two conditions that profoundly affect millions worldwide. This isn't just a clinical breakdown of molecules and lab tests; it’s a powerful reminder that behind every breakthrough lies persistence, genuine curiosity, and an unwavering desire to give patients a better life. discovery-transform-heart-failure-treatment
Aging, Author Interviews / 16.09.2025

[caption id="attachment_70701" align="aligncenter" width="500"]opportunities-aging-population Photo by Kampus Production[/caption]

Introduction

For healthcare and business leaders alike, the most powerful force shaping the 21st century may not be artificial intelligence or globalization, but aging populations. Since 1950, global life expectancy has risen by nearly 20 years, a monumental shift that is redefining consumer demand, workforce structures, and health systems. By 2050, one in six people worldwide will be over the age of 65, compared with just one in eleven in 2019 (United Nations, 2019). This demographic transformation is often framed as a looming burden—pressuring pension systems, overwhelming hospitals, and shrinking workforces. But this lens ignores a fundamental reality: aging societies also represent one of the largest hidden growth opportunities in healthcare innovation. The challenge is not the demographic trend itself, but how we adapt. For forward-looking companies, investors, and policymakers, reframing aging as a platform for innovation is a strategic imperative.
Author Interviews, Genetic Research, Neurological Disorders, Novartis / 29.03.2023

MedicalResearch.com Interview with: [caption id="attachment_60256" align="alignleft" width="137"]Sitra Tauscher-Wisniewski, Dr. Tauscher-Wisniewski,[/caption] 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.
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, Novartis / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49521" align="alignleft" width="170"]Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator. Dr. Fabrice André[/caption] Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator. MedicalResearch.com: What is the background for this study? How does Piqray®  differ from other treatments for this type of advanced breast cancer? 
  • The US Food and Drug Administration (FDA) approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test after disease progression following an endocrine-based regimen.
  • Piqray is the first and only combination treatment with fulvestrant specifically for postmenopausal women, and men, with HR+/HER2- advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen, bringing a biomarker-driven therapy option to this population for the first time.
  • Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may be eligible for treatment with Piqray plus fulvestrant combination therapy. 
Author Interviews, Multiple Sclerosis, Pharmacology / 27.09.2016

MedicalResearch.com Interview with: Marcia Kayath, MD Vice President and Head US Clinical Development and Medical Affairs US General Medicines Novartis Pharmaceuticals Corporation MedicalResearch.com: What is the background for this study? What are the main findings? Response: Injectable disease-modifying therapies (DMTs) are typically used first-line in patients with multiple sclerosis (MS), but discontinuation of injectable DMTs is common, especially within the first 12 months of treatment1,2. PREFERMS is the largest, prospective, randomized, active-controlled, open-label study to evaluate patient retention in patients with relapsing-remitting multiple sclerosis (RRMS). In the 12-month, Phase IV study, a total of 875 patients were randomized (1:1) to Gilenya® (fingolimod) 0.5 mg or to a pre-selected injectable DMT (IFNβ-1a, IFNβ-1b or glatiramer acetate), and followed up quarterly for 12 months3. After a minimum of 3 months of treatment, a single on-study treatment switch was allowed, however, switches due to efficacy or safety were allowed (based on patient-doctor consultation) at any month following randomization3. The primary endpoint was to compare the patient retention on randomized treatment over 12 months3. This study was powered for the primary endpoint (retention rate)3. The study was not powered to detect the treatment difference in the secondary efficacy endpoints or treatment effects related to switching study medication3.