Annals Internal Medicine, Author Interviews, COVID -19 Coronavirus / 18.04.2020

MedicalResearch.com Interview with: Nathan Stall, MD, FRCPC Geriatrics and Internal Medicine (Clinical Associate) Sinai Health System and the University Health Network Hospitals PhD Candidate, Clinical Epidemiology & Health Care Research Institute of Health Policy, Management and Evaluation Eliot Phillipson Clinician-Scientist Training Program
Vasily Giannakeas, MPH Epidemiologist/ Dedicated ICES Analyst Women's College Hospital Toronto, Ontario, Canada   MedicalResearch.com: What is the background for this study? Response: As some health care systems approach collapse, a pressing need exists for tools modeling the capacity of acute and critical care systems during the COVID-19 pandemic. We developed an online tool to estimate the maximum number of COVID-19 cases that could be managed per day within the catchment area served by a health care system, given acute and critical care resource availability. The COVID-19 Acute and Intensive Care Resource Tool (CAIC-RT) is open access and available at https://caic-rt.shinyapps.io/CAIC-RT. (more…)
Author Interviews, Colon Cancer, Gastrointestinal Disease, Pancreatic / 17.04.2020

MedicalResearch.com Interview with: Dr Cristina Bosetti PhD Head of the Unit of Cancer Epidemiology Mario Negri Department of Oncology Milan Italy MedicalResearch.com: What is the background for this study? Response: Aspirin has been known since long time to have a beneficial effect in the primary and secondary prevention of cardiovascular diseases. Additional evidence indicates that it has also a favorable role on the risk of various cancers. (more…)
Author Interviews, COVID -19 Coronavirus, Rheumatology / 16.04.2020

MedicalResearch.com Interview with: Ellen M. Gravallese M.D. President, American College of Rheumatology Dr. Gravallese discusses the recent guidance document issued by ACR for the treatment of rheumatic disease patients during the COVID-19 pandemic. MedicalResearch.com: What is the background for this announcement? Are patients with rheumatic disease at greater risk of severe illness or death from the SARS-CoV-2 virus?  Response: This week the ACR issued a guidance document that is the product of the ACR’s Clinical Guidance Task Force, a newly appointed task force that includes experts in infectious disease, as well as experts in biologic and non-biologic rheumatic disease therapies. This clinical guidance document was prepared to assist rheumatology professionals in the care of their patients during this novel pandemic, and to advise as to how to handle rheumatic disease therapies. There is no data to suggest that patients with rheumatic disease are at greater risk of severe illness or death simply because they have a rheumatic disease. Rheumatic disease patients appear to be at risk for poor outcomes if they become infected primarily because of general risk factors such as older age or comorbid medical conditions, such as significant heart or lung disease. A global alliance has been created by the rheumatology community that has developed an international case-reporting registry to collect information pertinent to COVID-19 infection in patients with rheumatic disease. The ACR has played an active role in helping the Alliance get their message out to the rheumatology community, and we continue to support the Alliance with its data dissemination and communication efforts. We hope this registry will provide valuable data to address additional questions about the best way to manage rheumatology patients affected by COVID-19 and we encourage providers to submit their COVID-19-related cases to the Alliance website at www.rheum-covid.org. (more…)
Author Interviews, Neurological Disorders, Parkinson's / 15.04.2020

MedicalResearch.com Interview with: Dr. Viviane Labrie, PhD Dr. Labrie is an associate professor in Van Andel Institute’s Center for Neurodegenerative Science, where she studies Parkinson’s, Alzheimer’s and other neurological diseases. MedicalResearch.com: What is the background for this study? Response: One of the most puzzling and persistent mysteries in neuroscience has been why some people are “right-brained” while others are “left-brained.” The two sides of the brain have different jobs. The left side is analytic and problem-solving, while the right side manages creativity and artistic talents. But despite their differences, the two sides are composed of the same cell types — essentially, brain neurons and their support cells. In this study, we sought to understand how it is possible for these cells to behave completely differently depending on what hemisphere they’re located in.  We also wanted to examine the reasons behind asymmetry in Parkinson’s disease; that is, why Parkinson’s symptoms typically start on one side of the body before the other. This asymmetry in neurodegeneration and symptoms in patients is one of the biggest unsolved puzzles in the Parkinson’s disease field — why do brain cells in one hemisphere begin dying before brain cells in the other hemisphere? (more…)
Author Interviews, Blood Pressure - Hypertension, UT Southwestern / 15.04.2020

MedicalResearch.com Interview with: DaiWai Olson, PhD, RN Professor of Neurology and Neurotheraputics UT Southwestern Medical Center MedicalResearch.com: What is the background for this study? Response: This study resonates across nursing. Kat Siaron is a Neuroscience nurse who had questions about the ‘best’ location for checking blood pressure. Like so many studies this started with a clinical question: “does it make a difference where you check the blood pressure?” She applied for a nursing research fellowship and was one of 6 nurses selected. She spent about 3 months reading articles on blood pressure and looking to see if there are any similar studies. After confirming that this has not been done, she submitted her study for approval from the Institutional Review Board and started data collection. (more…)
Author Interviews, COVID -19 Coronavirus, ENT / 15.04.2020

MedicalResearch.com Interview with: Ahmad R. Sedaghat, MD, PhD, FACS Associate Professor Department of Otolaryngology - Head and Neck Surgery University of Cincinnati College of Medicine Cincinnati, OH, USA   MedicalResearch.com: What is the background for this study? Response: The novel coronavirus, SARS-CoV-2, which causes COVID-19 infects the respiratory tract.  As a rhinologist, I am an expert in diseases of the nose and paranasal sinuses, and as the nose and paranasal sinuses (sinonasal cavities) are a major component of the upper airway, we decided to do a systematic review of the scientific literature on the role of the sinonasal cavities in COVID-19. (more…)
Author Interviews, COVID -19 Coronavirus, Diabetes / 14.04.2020

MedicalResearch.com Interview with: Daniel J. Drucker, M.D. Lunenfeld-Tanenbaum Research Institute Mount Sinai Hospital Toronto  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This review was prompted by shared mechanistic pathways linking actions of molecules such as ACE2 and DPP4, which are important enzymes with cardiometabolic actions, yet also function as coronavirus receptors. The recognition that people with diabetes and obesity are more prone to severe infection also highlights the importance of understanding the biology We highlight the intersection of pathways shared by coronavirus infection, and how these might impact our understanding of diabetes and its therapies. (more…)
Author Interviews, Diabetes, JAMA, Surgical Research / 14.04.2020

MedicalResearch.com Interview with: Katherine Moll Reitz, MD General Surgery Resident University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: Surgical interventions both save lives and improve the quality of those lives each day. However, these same interventions and the recovery thereafter are a major physiologic stressor. Younger, more resilient patients tend to recover faster, with fewer postoperative complications when compared to older, frailer patients undergoing the same surgical treatments. Therefore, investigators at University of Pittsburgh and UPMC have begun focusing on prehabilitation in order to optimize at risk patients preoperatively. Just as an athlete would train for an upcoming event, prehabilitation (including smoking cessation, healthy eating, and physical activity increases) prepares or trains patients for their surgical intervention and can improve their postoperative outcomes. Currently, there is no medication available to aid in this training process, improving patients’ response to the physiologic stress of surgery. Therefore, we are interested in exploring potential safe, well tolerated medical therapies which can optimize patients as pharmacologic prehabilitation. (more…)
Author Interviews, Endocrinology, OBGYNE / 14.04.2020

MedicalResearch.com Interview with: “Open Space Yoga Hawaii” by Open Space Yoga Hawaii is licensed under CC BY 2.0Diana Speelman, Ph.D. Director of Research for the College of Medicine Associate Professor of Biochemistry Reproductive System Course Coordinator L|E|C|O|M Erie, PA 16509 MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by PCOS? Response: Polycystic ovary syndrome (PCOS) is the most common hormone disorder in women of reproductive age.  It is characterized by high androgen levels (e.g., testosterone) in the blood and irregular menstrual cycles.  Despite affecting 5-15% of women, its cause is unknown.  While medications can be used to reduce androgen levels, or help achieve menstrual regularity or stimulate ovulation, these often have undesirable side effects.  Our goal was to investigate the effectiveness of non-pharmacologic approaches, including yoga, on improving the characteristics associated with the disorder.  (more…)
Abuse and Neglect, Author Interviews, COVID -19 Coronavirus / 14.04.2020

MedicalResearch.com Interview with: Dr. Naveen Vankadari PhD Research Fellow Monash University, Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: The recent outbreak of pneumonia-causing COVID-19 pandemic is an urgent global public health issue. It is critical to understand and unravel the key difference of COVID-19 or SARS-CoV-2 with the previous coronavirus (SARS and MERS) infections. Specifically, structural and molecular dynamics which underline the mechanism of viral infection. The study first addresses the structure of COVID-19 spike glycoprotein in both closed (ligand-free) and open (ligand-bound) conformation, which open the arena in understating the viral attachment to the host cell. The study also provides the first and complete sequence alignment of spike glycol protein from COVID19 and SARA-1, showing novel insertions and deletions that highlights the uniqueness of COVID19 and underlies the differential interaction mode. The study also unravels how this new coronavirus camouflages in humans through its unique glycosylation of spike glycoprotein, which makes the most of neutralizing antibodies useless. Furthermore, In addition to known ACE2 receptor in human, the study discovers the human CD26 as another potential receptor of COVID-19 for host adhesion and hijacking.  (more…)
Anesthesiology, Author Interviews, COVID -19 Coronavirus, OBGYNE / 13.04.2020

MedicalResearch.com Interview with: Dr. Alicia Warlick, MD Anesthesiologist at UNC/Rex, American Anesthesiology Raleigh, North Carolina MedicalResearch.com: As a physician working on the frontlines of the COVID-19 battle, how are you addressing expecting mothers’ concerns about the disease and how it might impact their pregnancy? Response: While COVID-19 has disrupted nearly every aspect of healthcare, whether its virtual appointments or delayed surgeries; there are certain things that are inevitable – like childbirth. As this virus continues to take over the country and we learn more about it each day, pregnant women are facing new challenges and fears. For women approaching their due dates, questions about staying healthy, keeping their baby safe and limiting their risk of exposure while in the hospital are all leading to anxiety and stress. And while policies and guidelines are constantly changing, as physicians we need to remind our patients that we are there to alleviate their concerns, address their questions and remind them to not lose sight of the joy the comes with bringing a child into the world. It’s a scary time for everyone, but by working together and supporting one another, we will get through this. (more…)
Accidents & Violence, Author Interviews, JAMA, Ophthalmology, Pediatrics / 13.04.2020

MedicalResearch.com Interview with: Natasha Nayak Kolomeyer, MD Glaucoma Service, Wills Eye Hospital Co-authors: Eric J. Shiuey, MS Sidney Kimmel Medical College, Thomas Jefferson University Anton M. Kolomeyer, MD, PhD Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania Philadelphia, Pennsylvania MedicalResearch.com: What is the background for this study? Response: I still remember the 6-year-old boy that was brought in to our emergency room on July 4th with a ruptured globe (severe eye trauma) due to fireworks; he permanently lost vision in that eye despite surgery. This is not a rare occurrence especially around certain holidays. (more…)
Author Interviews, COVID -19 Coronavirus, Heart Disease / 12.04.2020

MedicalResearch.com Interview with: Santiago Garcia, MD FACC Interventional Cardiologist, Minneapolis Heart Institute® Researcher, Minneapolis Heart Institute Foundation® MedicalResearch.com: What is the background for this study?  Response: We analyzed and quantified ST-segment elevation myocardial infarction (STEMI) activations for 9 high-volume (>100 primary percutaneous angioplasties per year) cardiac catheterization laboratories in the US. These centers represent different geographic areas and levels of COVID-19 exposure in the US. The data analyzed was from January 1, 2019 to March 31, 2020. Participating centers included 1-Minneapolis Heart Institute, Minneapolis, MN, 2- Beaumont Hospital Royal Oak, Royal Oak, MI, 3- The Christ Hospital, Cincinnati, OH, 4- Massachusetts General Hospital, Boston, MA, 5- UMass Memorial Medical Center, Worcester, MA, 6- Iowa Heart, Des Moines, IA, 7- Northwell Health Hospital, Manhasset, NY, 8- Prairie Cardiovascular, Springfield, IL, and 9- Swedish Medical Center, Seattle, WA. (more…)
Author Interviews, COVID -19 Coronavirus / 12.04.2020

MedicalResearch.com Interview with: Bart van Straten, Tim Horeman and John van den Dobbelsteen Research team TU Delft, Delft University of Technology, Dpt. of BioMechanical Engineering The Netherlands  MedicalResearch.com: What is the background for this study? Response: The background for this study was the urgent shortages of mouth masks in several hospitals. Franciscus Hospital, Rotterdam, The Netherland requested on 17 March if face masks could be sterilized since they were facing these shortages. The COVID-19 pandemic and its rapid spread has led to imminent shortages of these masks. (more…)
Author Interviews, JAMA, Pediatrics / 10.04.2020

MedicalResearch.com Interview with: Dr Alfredo Tagarro MD PhD Pediatrician - Hospital Universitario Infanta Sofía Clinical Research - Fundación Investigación Hospital Assistant Professor - Universidad Europea de Madrid Madrid MedicalResearch.com: What is the background for this study? Response: Madrid is being hit hard by the disease. Almost all doctors, including pediatricians, are dedicated to attending COVID-19 patients, essencially adults. However, there are some moderate and severe cases among children. In Madrid, clinical pediatricians from 30 hospitals joined their efforts to report and analyze pediatric patients with COVID-19.   (more…)
Author Interviews, COVID -19 Coronavirus, Diabetes / 10.04.2020

MedicalResearch.com Interview with: Gian Paolo Fadini, MD PhD Associate Professor of Endocrinology Department of Medicine, University of Padova Venetian Institute of Molecular Medicine  MedicalResearch.com: What is the background for this study? Response: Since the very beginning of the SARS-CoV-2 pandemic, it was suggested that It has been initially suggested that diabetes mellitus is one of the most common comorbidities in infected people, but its exact prevalence is unclear. However, exact numbers were uncertain. We have addressed this issue in a study published as a letter in the Journal of Endocrinological Investigation. (more…)
Addiction, Annals Internal Medicine, Author Interviews, NIH, Opiods / 10.04.2020

MedicalResearch.com Interview with: Nora D. Volkow, MD Director of the National Institute on Drug Abuse National Institutes of Health Bethesda, MD MedicalResearch.com: What is the background for this study? How does vaping, hookah use, inhaled marijuana, smoking etc impact the risk of coronavirus infection?  Could these activities account for some the risks and infections in younger individuals?   Response: Apart from older age, having underlying cardiopulmonary conditions is a known risk factor for the worst clinical course and outcomes of COVID-19, and many of those conditions are known to be caused or exacerbated by smoking. While evidence continues to emerge about how smoking might interact with COVID-19, it is a reasonable assumption that smoking could contribute to risk even in younger individuals. We still don’t know how vaping—whether of nicotine or marijuana or just flavorings—contributes to the risk of infection or illness severity with the virus that causes COVID-19, but there are a number of reasons to be concerned. We have already seen lung illnesses caused by some vaping products, and evidence suggests vaping may disrupt lung epithelial cell function, which in turn increases viral susceptibility and may put individuals at increased risk of infection with the virus that causes COVID-19 or with more severe disease outcomes. Vaping is a relatively new technology, and as such, there are many unknowns. The rapid increases in vaping by young people over the last few years make this an area of concern, and thus an area where more research is urgently needed. (more…)
Author Interviews, JAMA, Kidney Disease, Medicare / 10.04.2020

MedicalResearch.com Interview with: Lead and Senior coauthors contributing to this interview: Abby Hoffman, BA is a Pre-Doctoral Fellow in Population Health Sciences at Duke University and a PhD Candidate in Health Policy and Management University of North Carolina at Chapel Hill. Virginia Wang, PhD, MSPH is an Associate Professor in the Department of Population Health Sciences, Associate Director of the Center for Health Innovation and Outcomes Research, and Core Faculty in the Margolis Center for Health Policy at Duke University and Investigator at the Durham VA HSR&D Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT).   MedicalResearch.com: What is the background for this study? Response: It is well established that healthcare providers are sensitive to changes in price, though their behavioral response varies. Dialysis facilities are particularly responsive to changes in Medicare reimbursement. Many dialysis patients are eligible for Medicare regardless of age, but dialysis facilities generally receive significantly higher reimbursement from private insurers than from Medicare. In 2011, Medicare implemented a new prospective bundled payment for dialysis that was expected to decrease Medicare payment and reduce overall revenues flowing into facilities. Then the Affordable Care Act (ACA) rules against refusing to insure patients for preexisting conditions and the 2014 ACA Marketplace provided an additional avenue for patients to purchase private insurance. As a result of these policies, dialysis facilities had a strong motivation and opportunity to increase the share of patients with private insurance coverage. We were interested in understanding whether dialysis facilities were shifting their payer mix away from Medicare, possibly in response to these policy changes.  (more…)
ASCO, Author Interviews, Cancer Research, Journal Clinical Oncology / 10.04.2020

MedicalResearch.com Interview with: Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Would you explain what is meant by switch maintenance immunotherapy? Response: For decades, platinum-based chemotherapy has been standard first-line treatment for metastatic urothelial (bladder) cancer. The standard approach to first-line chemotherapy is to administered approximately 6 cycles of treatment (in the absence of disease progression or prohibitive side effects), and then to stop treatment and monitor. Unfortunately, virtually all patients with metastatic disease will experience disease progression after stopping chemotherapy. However, we know that if we just continue the same platinum-based chemotherapy until progression of cancer (rather than stopping after ~6 cycles), the side effects continue to accumulate but the benefits plateau. Approximately 5 years ago, the first new systemic therapies were approved to treatment metastatic urothelial cancer in decades, immune checkpoint inhibitors (PD-1 or PD-L1 inhibitors). In fact, 5 PD-1/PD-L1 inhibitors have been approved by the FDA for the treatment of patients with metastatic urothelial cancer progressing despite prior platinum-based chemotherapy. Given that these drugs are non-cross resistant with chemotherapy in at least a subset of patients (i.e., they can provide benefit even when chemotherapy is no longer working), and because they are well tolerated by a large proportion of patients, a logical question is rather than waiting until cancer progresses after stopping first-line chemotherapy, what if we started immunotherapy immediately. Switch maintenance refers to switching from chemotherapy to a different class of drug (e.g., immunotherapy) and maintenance refers to trying to "maintain" the response achieved with initial chemotherapy. (more…)
Addiction, Author Interviews, Cannabis / 10.04.2020

MedicalResearch.com Interview with: Anees Bahji, MD PGY5, Department of Psychiatry, Queen’s University M.Sc. Candidate, Department of Public Health Sciences, Queen’s University Kingston, ON, Canada MedicalResearch.com: What is the background for this study?
  • There has been much speculation into the existence of a withdrawal syndrome involving cannabis much like withdrawal syndromes from opioids or alcohol. Our goal for this study was to estimate the prevalence of cannabis withdrawal syndrome (CWS) and to identify any risk factors for CWS.
  • There has been a lot of research into cannabis withdrawal syndrome (CWS) in the past. A big part of this review involved understanding where the CWS field is in terms of the shared understanding on its epidemiology and physiology.
  • To that end, we were not surprised to find that the prevalence of cannabis withdrawal syndrome was high. However, we found that some of the characteristics of CWS are consistent with other substance use disorders, which really serves to legitimize the decision to classify CWS and cannabis use disorders as psychiatric conditions.
(more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, Weight Research / 08.04.2020

MedicalResearch.com Interview with: Zhen Yang MD PhD Department of Endocrinology, Xinhua Hospital Shanghai Jiao Tong University School of Medicine Shanghai, China   MedicalResearch.com: What is the background for this study? Response: Hypertension is a major public health problem affecting more than 1 billion people worldwide. And it is the leading cause of mortality and disability globally. Startlingly, more than half of people with elevated blood pressure were unaware of their hypertensive status in numerous surveys, partly owing to hypertension rarely shows symptoms in the early stages. Hence, hypertension is a silent killer. (more…)
Author Interviews, COVID -19 Coronavirus, Infections, University of Michigan / 08.04.2020

MedicalResearch.com Interview with: Arnold S. Monto, M.D. Professor, Epidemiology Professor, Global Public Health Thomas Francis, Jr. Collegiate Professor of Public Health University of Michigan  MedicalResearch.com: What is the background for this study? Response: This is part of a continuing study in families first designed to examine how influenza vaccine is working in the community  We have expanded it to look broadly at all respiratory viruses There are 4 coronaviruses which are known to cause respiratory illnesses each year and we had these data ready to go when the pandemic started. (more…)
Aging, Author Interviews, Mental Health Research / 08.04.2020

MedicalResearch.com Interview with: Leeann Mahlo Registered Psychologist PhD (Clinical Psychology) Candidate College of Education, Psychology and Social Work Flinders University MedicalResearch.com: What is the background for this study? Response: Mindfulness can be instrumental in reducing stress and promoting positive psychological outcomes. However, few studies have considered the positive effects of mindfulness on psychological functioning from a lifespan perspective. Our research aimed to examine the role of age in the relationships between specific aspects of mindfulness and psychological flexibility and well-being. (more…)
Accidents & Violence, Author Interviews, JAMA, Johns Hopkins, Pediatrics / 07.04.2020

MedicalResearch.com Interview with: Johnathon P. Ehsani, PhD Assistant Professor Johns Hopkins School of Public Health MedicalResearch.com: What is the background for this study? Response: Car crashes are the leading cause of death and disability for young people. So, what can parents do during the learner stage of licensing to reduce their teenagers’ crash risk during independent driving? The learner stage is a brief window of opportunity to influence the safety of their teenager. This is when teenagers are required to practice driving under the supervision of a licensed adult – typically mom or dad. Once teenagers get their license to start driving on their own, their crash risk increases - but parents have fewer chances to intervene at that point.  (more…)
Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 07.04.2020

MedicalResearch.com Interview with: Paul B. McCray, Jr., M.D. Professor of Pediatrics, Microbiology, and Internal Medicine Executive Vice Chair of Pediatrics Associate Director: Center for Gene Therapy Roy J. Carver Chair in Pulmonary Medicine Pappajohn Biomedical Institute Carver College of Medicine University of Iowa, Iowa City, IA  52242 MedicalResearch.com: What is the background for this study? Response: In the face of the COVID-19 pandemic, there is great interest in developing a vaccine that could help protect people from infection with SARS-CoV-2.  Over the last 15 years, my laboratory has helped develop small animal models of the severe coronavirus diseases SARS and MERS to study disease pathogenesis and to test treatments.  In this study, we used a mouse model of the MERS coronavirus to test a vaccine idea in collaboration with Dr. Biao He at the University of Georgia. (more…)
Author Interviews, Baylor College of Medicine Houston, COVID -19 Coronavirus, JAMA, Stanford / 07.04.2020

MedicalResearch.com Interview with: Melissa Bondy, PhD Chair, Department of Epidemiology and Population Health Stanford University  MedicalResearch.com: What is the background for this study? Response: Faculty researchers in Stanford’s Department of Epidemiology & Population Health and collaborators from Baylor College of Medicine and Stanford’s Department of Dermatology developed an online survey aimed at rapidly assessing public concerns about the COVID-19 crisis. This survey, which was posted on 3 social media platforms (Twitter, Facebook, and Nextdoor) on March 14, 2020, collected invaluable data about COVID-19, including symptoms, concerns, and individual actions taken by respondents. Twitter and Facebook posts were sharable to facilitate snowball sampling. The survey was comprised of 21 (multiple-choice, single-choice, numeric, and open-ended) questions, which were designed to collect data concerning respondent demographics and recent cold and flu-like illnesses (if any), as well as information about participants’ concerns and any lifestyle changes that occurred as a result of the COVID-19 crisis. All questions were optional, so response rates were variable.  (more…)
Author Interviews, COVID -19 Coronavirus, Infections, Pediatrics / 07.04.2020

genentech MedicalResearch.com: What are the applicable pediatric and post-exposure indications? Response: We recently announced that the U.S. FDA has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted an NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours. The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation. (more…)