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| dupixent fda approval history: Hepatotoxicity Hyman J. Zimmerman, 1999 Written by the foremost authority in the field, this volume is a comprehensive review of the multifaceted phenomenon of hepatotoxicity. Dr. Zimmerman examines the interface between chemicals and the liver; the latest research in experimental hepatotoxicology; the hepatotoxic risks of household, industrial, and environmental chemicals; and the adverse effects of drugs on the liver. This thoroughly revised, updated Second Edition features a greatly expanded section on the wide variety of drugs that can cause liver injury. For quick reference, an appendix lists these medications and their associated hepatic injuries. Also included are in-depth discussions of drug metabolism and factors affecting susceptibility to liver injury. |
| dupixent fda approval history: Personalizing Asthma Management for the Clinician Stanley J. Szefler, Fernando Holguin, Michael E Wechsler, 2017-09-22 Personalized medicine is a rapidly emerging area in health care, and asthma management lends itself particularly well to this new development. This practical resource by Dr. Stanley J. Szefler helps you navigate the many asthma medication options available to your patients, as well as providing insights into those which may be introduced within the next several years. - Features a wealth of information on available asthma medications, including new immunomodulators, new responses to treatment, and new treatment strategies at all levels of asthma care. - Prepares you to meet your patients' needs regarding asthma exacerbation prevention and asthma prevention. - Consolidates today's available information and guidance in this timely area into one convenient resource. |
| dupixent fda approval history: Chronic Rhinosinusitis Wytske J. Fokkens, 2009 This issue will focus on treatments for Chronic Rhinosinusitis. Dr. Wyste Fokkens guest edits topics such as: Inflammatory mechanisms in chronic rhinosinusitis with or without nasal polyposis, European versus Asian Chronic rhinosinusitis. What did it teach us and what do we want to know, Epithelium, cilia and mucus, their importance in chronic rhinosinusitis Noam Cohen Noam, Aspirin intolerance: does desensitization alter the course of the disease, Anti-inflammatory effects of macrolides: applications in CRS, and more! |
| dupixent fda approval history: Guide for Aviation Medical Examiners , 1992 |
| dupixent fda approval history: Severe Asthma Kian Fan Chung, Elliot Israel, Peter G. Gibson, 2019-06-01 Severe asthma is a form of asthma that responds poorly to currently available medication, and its patients represent those with greatest unmet needs. In the last 10 years, substantial progress has been made in terms of understanding some of the mechanisms that drive severe asthma; there have also been concomitant advances in the recognition of specific molecular phenotypes. This ERS Monograph covers all aspects of severe asthma – epidemiology, diagnosis, mechanisms, treatment and management – but has a particular focus on recent understanding of mechanistic heterogeneity based on an analytic approach using various ‘omics platforms applied to clinically well-defined asthma cohorts. How these advances have led to improved management targets is also emphasised. This book brings together the clinical and scientific expertise of those from around the world who are collaborating to solve the problem of severe asthma. |
| dupixent fda approval history: Biologics, Biosimilars, and Biobetters Iqbal Ramzan, 2021-02-03 A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists |
| dupixent fda approval history: Immune Rebalancing Diana Boraschi, Giselle Penton-Rol, 2016-01-25 Immune Rebalancing: The Future of Immunosuppression summarizes the most promising perspectives of immunopharmacology, in particular in the area of immunosuppression by considering molecular pathways, personalized medicine, microbiome and nanomedicine. Modulation of immune responses for therapeutic purposes is a particularly relevant area, given the central role of anomalous immunity in diseases. These diseases vary from the most typically immune-related syndromes (autoimmune diseases, allergy and asthma, immunodeficiencies) to those in which altered immunity and inflammation define the pathological outcomes (chronic infections, tumours, chronic inflammatory and degenerative diseases, metabolic disorders, etc. - Visits immunosuppression from a modern point of view of signalling mechanisms at the light of the current knowledge of signalling mechanisms and regulatory networks allows the reader to formulate new ideas and concepts on how to use immunosuppression the therapeutic purposes - Encourages researchers to engage into exploring the field of pharmacological modulation of immune responses in depth, and with the new knowledge and tools available, designs more effective therapeutic strategies to autoimmune and inflammatory diseases, cancer, degenerative diseases and infections - Examines the link between molecular pathways associated to immune-suppression and the new immunopharmacology approaches - Provides information on the new strategies for drug development in this field - Considers the role of microbes in the development of the mammalian immune system and immune responses, which will widen the reader's strategy for addressing therapeutic immune modulations |
| dupixent fda approval history: Immunologic Concepts in Transfusion Medicine Robert W Maitta, 2019-08-27 Immunological Concepts in Transfusion Medicine provides a thorough discussion of the immune aspects of blood component transfusion, with in-depth information on the intricacies of immune responses to blood components and the immune processes that may be initiated in response to blood exposure. Written to increase knowledge and awareness of immune challenges such as alloimmunization and transfusion-related acute lung injury, this title bridges current basic scientific discoveries and the potential effects seen in blood recipients. - Complies the knowledge and expertise of Dr. Robert Maitta, an expert in immune responses and antibody function/structure studies. - Helps clinicians in the daily practice of caring for patients in need of transfusion support, as well as physicians in training when considering utilizing blood transfusions in a limited scope or in the setting of massive transfusion. - Includes an immunology primer as an introduction to in-depth chapters covering allergic immune reactions to blood components, transfusion-related immunomodulation, fetal and neonatal alloimmune thrombocytopenia and neonatal neuthropenia, complications of haploidentical and mismatched HSC transplantation, chimeric antibody receptor therapies, and much more. - Consolidates today's available information on this timely topic into a single, convenient resource. |
| dupixent fda approval history: Severe Asthma in Children and Adolescents Erick Forno, Sejal Saglani, 2019-11-13 This book provides readers with a comprehensive review of severe asthma in children and adolescents, covering epidemiology, genetics, risk factors, co-morbidities, clinical presentation, diagnosis and treatment. Written by leaders in the field, chapter discussions draw on the mechanisms driving the disease, genetics, multidisciplinary approaches, immunomodulators, and other important aspects in the management of the disease. Severe Asthma in Children and Adolescents: Mechanisms and Management is designed to be a practical guide, opening with an introduction on the epidemiology of severe childhood asthma, as well as a discussion of special considerations of the disease unique to the preschool-aged patient. The distinctions between the diagnosis and management of asthma in young children of various ages, and specific approaches for the adolescent with severe asthma, including the transition into adult care are then addressed. Finally, the book closes with a discussion on the current state and future avenues for severe asthma research. Severe Asthma in Children and Adolescents is an indispensable reference for the healthcare professional, for basic and translational researchers, as well as for students, residents and fellows. |
| dupixent fda approval history: Pharmacology of Immunotherapeutic Drugs Clinton B. Mathias, Jeremy P. McAleer, Doreen E. Szollosi, 2019-10-18 Medicine has entered a golden age in which therapeutic agents are becoming widely available due to advances in basic science and technology. As such, many drugs have been developed that target inflammatory processes and/or the immune system. This book is intended for health professionals examining the modulation of inflammation by immunotherapeutic drugs. The immune system fills the primordial role of host defense and resistance to infections with pathogenic microorganisms. Several hematopoietic-derived cells constituting the innate and adaptive immune systems cooperate to provide barriers for microbial colonization and/or promote pathogen destruction within the host. Conversely, many immune cells are also involved in the pathogenesis and propagation of chronic inflammatory diseases. The beginning of this book details various components of the immune system including the cell types, lymphoid tissues, soluble cytokines and surface molecules that are essential for host defense. Breakdowns in immune tolerance, or dysregulated immune responses to antigens derived from self tissues or innocuous sources, can lead to the development of autoimmunity or chronic inflammatory diseases. Pathophysiologic roles for the immune system are detailed in corresponding chapters on autoimmunity, epithelial surfaces (lungs, skin, intestine), and transplantation, with special emphasis placed on immunotherapeutic drug targets. The last section of the book focuses on treatments that stimulate our immune system to specifically target and fight infectious diseases and cancer. In each chapter, the medications used to treat various diseases/conditions in terms of their mechanism of action and other pharmacologic properties are detailed. Chapters begin with a table showing drug names and classifications. The importance of basic science and clinical trials cannot be understated in the context of drug development. As such, the discovery of certain medications that had a lasting impact in medicine and pharmacy are highlighted in chapter subsections named “Bench to Bedside.” Several clinical applications of immunotherapeutic drugs are described within end-of -chapter case studies including practice questions. The Pharmacology of Immunotherapeutic Drugs is a reference for immunologists and clinicians (medical doctors, pharmacists, nurses) examining the modulation of inflammatory processes by a variety of medications targeting the cells and mediators of our immune system. |
| dupixent fda approval history: The Right Price Peter J. Neumann, Joshua T. Cohen, Daniel A. Ollendorf, 2021 The prescription drug market -- Proposed solutions for rising drug prices -- Measuring the value of prescription drugs -- Measuring drug value : whose job is it anyway? -- Institute for Clinical and Economic Review (ICER) -- Other US value assessment frameworks -- Do drugs for special populations warrant higher prices? -- Improving value measurement -- Aligning prices with value -- The path forward. |
| dupixent fda approval history: Allergy and Asthma , 2019-06-25 Allergy and Asthma: The Basics to Best Practices is intended to serve as a single comprehensive reference covering all needed knowledge of allergic diseases. Allergy is a unique and distinctive area of medicine wherein learning the fundamentals requires gathering information from various different disciplines. Allergic diseases affect various organ systems and the practice of a wide range of physicians from otolaryngologists, and pulmonologists, to gastroenterologists, dermatologists, and ophthalmologists. Clinicians and trainees alike will benefit from a resource that introduces the basic concepts, as well as providing comprehensive, consistently up-to-date instruction on intermediate and advanced conditions, research, and treatment strategies. The book is divided into nine sections and is written by some of the foremost experts in the field. Allergy and Asthma opens with an introduction which covers the epidemiology of allergic diseases, fundamentals of allergy and immunology, and a thorough grounding of different types of allergens. Early sections address allergic upper airway diseases, allergic skin diseases, and asthma in detail, using a structured, consistent format from chapter to chapter to provide continuity and ease of reference. Later sections thoroughly cover various food allergies, insect allergies, drug allergy, anaphylaxis, and utilize ample tables and illustrations to provide additional learning tools for the reader. This major reference not only provides basic knowledge on diagnosing and treating allergies, but moves beyond these basics to emphasize using a systematic approach to working up and treating a patient. A variety of techniques used in diagnosing asthma and allergy will be examined, of which include prick skin tests, in-vitro testing, patch testing and non-conventional allergy tests. Concluding this book are sections dedicated to management, therapeutic strategies of allergy and asthma, with a look to future research directions for this unique field. Physicians and residents in allergy and immunology, pulmonology, otolaryngology, gastroenterology, dermatology, ophthalmology and other specialties will find the work of value in enhancing their practice and studies. Researchers in a range of areas especially immunology and food science will also find this text to be a compelling and reliable resource. |
| dupixent fda approval history: Cutaneous T-Cell Lymphoma Herschel S. Zackheim, 2004-10-28 Cutaneous T-cell lymphoma (CTCL) is a general term for many lymphomas of the skin including mycosis Fungoides and Sezary syndrome. This book presents the state of the art in CTCL epidemiology, clinical features, pathology, immunochemistry, diagnostic molecular techniques, staging and prognosis, and treatment. Edited by one of the leading experts in |
| dupixent fda approval history: Pharmacoeconomics Renee J. G. Arnold, 2016-04-19 The pharmaceutical industry is almost boundless in its ability to supply new drug therapies, but how does one decide which are the best medicines to use within restricted budgets? With particular emphasis on modeling, methodologies, data sources, and application to real-world dilemmas, Pharmacoeconomics: From Theory to Practice provides an introduc |
| dupixent fda approval history: Immunotherapy – A Novel Facet of Modern Therapeutics Sujata P. Sawarkar, Vandana S. Nikam, Shariq Syed, 2020-12-16 This book illustrates the significance and relevance of immunotherapy in modern-day therapeutics. Focusing on the application of immunotherapy in oncology, neurodegenerative and autoimmune diseases, it discusses the drug delivery systems, and pre-clinical and clinical methodologies for immunotherapy-based drugs. It also comprehensively reviews various aspects of immunotherapy, such as regulatory affairs, quality control, safety, and pharmacovigilance. Further, the book discusses the in vitro validation of therapeutic strategies prior to patient application and management of immunotherapy-related side effects and presents case studies demonstrating the design and development (pre-clinical to clinical) of immunotherapy for various diseases. It also describes various design considerations and the scale-up synthesis of immunotherapeutics and screening methods. Lastly, it explores the important aspect of cost-effectiveness and rational immunotherapy strategies. |
| dupixent fda approval history: Lehne's Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants - E-Book Laura D. Rosenthal, Jacqueline Rosenjack Burchum, 2020-02-28 **Selected for Doody's Core Titles® 2024 in Pharmacology** Lehne's Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants, 2nd Edition builds on the same foundation of clearly explained, up-to-date, and clinically current content as the trusted Lehne undergraduate text, while focusing on the information that advanced practice nurses and Physician Assistants specifically need for safe and effective prescribing. Three introductory chapters provide foundational content for new prescribers in the areas of prescriptive authority, rational drug selection, prescription writing, and promoting positive outcomes of drug therapy. Core drug chapters are focused on the drugs that prescribers will most commonly see in clinical practice. A sharp focus is also placed on pharmacotherapeutic decision-making, with Black Box Warnings and new bulleted Key Prescribing Considerations features. The second edition features completely new chapters on Genetic and Genomic Considerations, Muscarinic Antagonists and Immunomodulators, and updated content throughout. It's everything advanced practice nursing and Physician Assistant students need to be safe and effective prescribers! - Introductory chapters tailored to the specific needs of prescribers cover topics such as prescriptive authority, rational drug selection and prescription writing, and promoting positive outcomes of drug therapy. - Carefully focused pharmacotherapeutic content reflects the drugs most commonly seen and used by prescribers, with emphasis not on the first drug discovered or developed in each class but on the agents most often used today. Primary care drugs are addressed first in each chapter as appropriate, followed by acute care drugs. - UNIQUE! Prescriber-focused pedagogical aids further reinforce the most important information for prescribers. - Integrated coverage of Canadian trade names appears throughout the text and is highlighted with a familiar maple-leaf icon. - Integrated coverage of interprofessional collaboration addresses the growing global interest in interprofessional collaboration and incorporates opportunities for interprofessional collaborative practice throughout. |
| dupixent fda approval history: Management of Atopic Dermatitis Steven R. Feldman, |
| dupixent fda approval history: Adverse Reactions to Biologics L. Puig, W. Gulliver, 2017-11-07 In many areas of medicine physicians still face the great challenge of finding therapies that will meet the patients’ needs. In dermatology the challenge has arisen on multiple fronts through advances in the understanding of the immunopathogenesis of many inflammatory and malignant cutaneous disorders. Breakthroughs, combined with significant developments in targeted immunotherapy, have resulted in improved outcomes as these newer therapies are being used for both approved indications and as off-label therapies for various chronic inflammatory skin disorders and many forms of skin cancer. In the expectation that by truly understanding the safety profile of these targeted therapies patients’ outcomes will be significantly improved, this book offers insights into topics such as adverse reactions, infectious complications and the perioperative use of biologics in psoriasis, immunogenicity of biologic therapies, paradoxical reactions, safety of biologics used to treat autoimmune bullous diseases and primary cutaneous lymphomas, adverse reactions and skin manifestations of therapies targeting melanoma and non-melanoma skin cancer and other neoplastic diseases. Eminent researchers with extensive clinical experience have contributed to this publication, providing an in-depth overview of the latest knowledge in this field. |
| dupixent fda approval history: AARP Allergic Girl Sloane Miller, 2012-04-19 AARP Digital Editions offer you practical tips, proven solutions, and expert guidance. AARP Allergic Girl is an indispensable guide for living a full life with food allergies--from an Allergic Girl who lives it. Millions of Americans concerned about adverse reactions to food are seeking the advice of medical professionals and receiving a diagnosis of food allergies. Allergic Girl Sloane Miller, a leading authority on food allergies, has been allergic since childhood. She now lives a full, enjoyable life full of dining out, dating, attending work functions, and traveling. With tested strategies and practical solutions to everyday food allergy concerns, Allergic Girl shows how readers can enjoy their lives too. Informed by personal narratives laced with humor and valuable insights, Allergic Girl is a breakthrough lifestyle guide for food-allergic adults, their families, and loved ones. In Allergic Girl, you will discover: How to find the best allergist and get a correct diagnosis How to create positive relationships with family, friends, and food How to build a safe environment wherever you are Real-world scenarios scripted from the author's life as well her work with clients and other leaders in the field Enjoy your food-allergic life to the fullest. Let Allergic Girl show you how. |
| dupixent fda approval history: Head, Neck and Orofacial Infections - E-book James R. Hupp, Elie M. Ferneini, 2024-06-07 Providing full-color coverage of best practices, Head, Neck, and Orofacial Infections: An Interdisciplinary Approach, 2nd Edition, is an authoritative resource offering in-depth guidelines to the diagnosis and management of pathology due to severe infections. Comprehensive, evidence-based coverage presents both cutting-edge and time-tested approaches to recognizing and handling infections. From well-known academia and clinical educator James Hupp and accomplished surgeon Elie Ferneini, with chapters authored by expert contributors, this book is ideal for use as a clinical resource for a wide array of healthcare providers, as well as to prepare for licensure examination and board certification. NEW! Cutting-edge content covers microbiologic nomenclature, anti-microbial agents, understanding of viruses and anti-viral drugs, the management of patients during pandemics, and the team approach to managing infections of unknown origin or resistant to the usual treatment strategies. NEW! Full-color clinical images enhance understanding of key concepts in the text. NEW! eBook version, included with print purchase, provides access to all the text, figures, and references with the ability to search, customize content, make notes and highlights, and have content read aloud. UPDATED! Appendices include illustrative case reports. Comprehensive, easy-to-read coverage addresses the basic science, clinical diagnosis, and holistic management of a broad range of head, neck, and orofacial infections with both time-tested and cutting-edge approaches to patient management. More than 500 photographs, radiographs, and illustrations demonstrate pathologies, procedures, and outcomes. World-class authors and contributors share their expertise from the disciplines including infectious disease, head and neck surgery, oral and maxillofacial surgery, plastic surgery, and otolaryngology, as well as other disciplines involving severe infections of the head, neck, and orofacial regions. State-of-the-art guidance reflects extensive experience with current techniques, as well as technological advances in managing head, neck, and orofacial infections. A logical, sectioned approach to the content includes three sections: I) issues that are common to all infections of the head and neck region, II) infections of specific parts of the region, and III) infections related to certain procedures, types of patients, unusual organisms, and medical-legal implications. |
| dupixent fda approval history: Immunopharmacology and Inflammation Carlo Riccardi, Francesca Levi-Schaffer, Ekaterini Tiligada, 2018-06-09 A comprehensive overview of the current research on inflammation and immunopharmacology, with particular attention to the use of anti-inflammatory drugs, this book discusses future trends in this area of pharmacological research. It addresses an audience with basic knowledge in the inflammatory process, immune system and pharmacology. The book meets the needs of graduate students, junior and senior researchers and is useful as a source of the most current information for those already working in these fields. |
| dupixent fda approval history: Food and Drug Administration's Role in Dermatology, An Issue of Dermatologic Clinics,E-Book Markham C. Luke, 2022-06-24 In this issue, guest editors bring their considerable expertise to this important topic.Provides in-depth reviews on the latest updates in the field, providing actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create these timely topic-based reviews. |
| dupixent fda approval history: Dermato-Oncology Study Guide Vincent Liu, 2021-03-23 This book provides clinicians, clinicians-in-training and researchers with a unique rapid-access educational resource on the spectrum of issues at the intersection of skin and malignancy. In it, there is clinical detail provided on how the skin reveals systemic malignancy via cutaneous metastases, genodermatoses or paraneoplastic dermatoses. At the same time, it reviews pharmacologic treatment of internal malignancy and how this can result in cutaneous adverse reactions; conversely, therapeutics for skin conditions can increase risk for internal malignancy. As arguably the most significant cutaneous malignancy, melanoma receives specific attention for its metastatic potential, current diagnostic advances, and recent therapeutic breakthroughs. Dermato-Oncology Study Guide: Essential Text and Review serves a critical educational need for clinicians caring for patients with systemic malignancy by creating an easy-to-use resource that provides practical tools to recognize skin signs of internal malignancy. Furthermore it helps in anticipating and managing adverse reactions of therapeutics for systemic malignancy, and gives the reader the opportunity to weigh the risks of malignancy of pharmacologic agents for skin disease. |
| dupixent fda approval history: Death to Beauty Eugene M. Helveston, 2024-01-30 In the 1970s, Dr. Alan Scott sought to selectively weaken eye muscles to treat strabismus (when one or both eyes are misaligned) without surgery. After failed attempts with other agents, Scott developed a method to stabilize the bacteria that causes botulism, culminating in a drug that eventually became known as Botox. In Death to Beauty, Eugene M. Helveston, MD, follows the unlikely story of botulism's 1817 discovery in contaminated German sausages, to its use in military and research facilities, to Scott, an ophthalmologist who aimed to safely use the drug in humans. Scott struggled alone as an unknown in the pharmaceutical industry, searching for clinical trial financing and FDA approval, which he achieved at a fraction of the billions big pharma usually spends to bring a drug to market. Eventually, the company Allergan bought him out, capitalizing on the possibilities for cosmetic uses. Scott's formula was renamed Botox and reached annual sales in the billions. After the sale, Scott received no further compensation from Botox sales and remained the same unassuming man. A fascinating walk through the intricate history of how the world's deadliest toxin starting as a treatment for crossed eyes became a routine tool for the cosmetic industry, Death to Beauty will make you rethink success, beauty, and deadly bacteria. |
| dupixent fda approval history: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
| dupixent fda approval history: Pathology of Pediatric Gastrointestinal and Liver Disease Pierre Russo, Eduardo D. Ruchelli, David A. Piccoli, 2012-12-06 Pediatric gastrointestinal and liver biopsies comprise a significant portion of specimens examined by the pathology laboratory. The increasingly widespread use of endoscopic procedures in children, the improved sophistication of medical imagery, as well as expanding knowledge in genetic medicine have led to new advances and opportunities in pediatric hepatogastroenterology and pathology. Pathology of Pediatric Gastrointestinal and Liver Disease will provide the pediatric pathologist, GI and general pathologist and pediatric gastroenterologist with the most current and complete reference on the pathology of pediatric GI and liver diseases. With an emphasis on clinical pathological correlation, and edited by a multi-disciplinary team of pathologists and a gastroenterologist, the book will provide in-depth discussions on topics frequently encountered and for which currrent information is not readily available. Comprised of 16 chapters following an anatomical outline, the text will cover both the GI and liver and will include discussions on: malabsorption and motolity disorders, immunodeficiencies, including HIV, development malformations, food allergies, cystic diseases of the liver, esophageal and pancreatic disorders. Heavily illustrated with over 450 illustrations, 200 of which in full color throughout, the book will include endoscopic and radiographic images to correlate with the pathologic principles under discussion. |
| dupixent fda approval history: Targeted Therapies in Breast Cancer Gw Sledge, George W. Sledge (Jr.), 2012-06 This new volume updates the reader on selected areas of targeted therapy in breast cancer, with special emphasis on chemoprevention strategies, drug resistance, biomarkers, combination chemotherapy, angiogenesis inhibition and pharmacogenomics in the context of clinical efficacy. This selected review of targeted therapies will guide the reader on effective treatment as part of an integrated programme of patient management. |
| dupixent fda approval history: Good Pharma Donald W. Light, Antonio F. Maturo, 2015-06-30 Drawing on key concepts in sociology and management, this history describes a remarkable institute that has elevated medical research and worked out solutions to the troubling practices of commercial pharmaceutical research. Good Pharma is the answer to Goldacre's Bad Pharma: ethical research without commercial distortions. |
| dupixent fda approval history: Roadmapping Future Tuğrul U. Daim, 2021-03-16 This volume presents a portfolio of cases and applications on technology roadmapping (TRM) for products and services. It provides a brief overview on criteria or metrics used for evaluating the success level of TRM and then offers six case examples from sectors such as transportation, smart technologies and household electronics. A new innovation in this book is a section of detailed technology roadmap samples that technology managers can apply to emerging technologies. |
| dupixent fda approval history: Dermatologic Principles and Practice in Oncology Mario E. Lacouture, 2013-11-26 The first book focusing specifically on frequent and frequently disabling side effects involving the skin, hair and nails in cancer patients According to the World Health Organization, there are approximately thirty million people living with a diagnosis of cancer – the majority of whom will receive surgery, systemic therapy, and/or radiation, and who will suffer from dermatologic adverse events. Dermatologists and oncologists are only beginning to grapple with these events, which pose serious quality-of-life issues with so many patients, and will become more prevalent as survival rates improve, thanks in part to new cancer treatments and drug regimens. Concentrating on a topic that has only been briefly touched upon by other texts, this book offers a focused perspective on the clinical presentation, underlying pathophysiologic mechanisms, and management of skin, hair, and nail conditions for oncologists, dermatologists, and allied practitioners. Dermatologic Principles and Practice in Oncology: Conditions of the Skin, Hair, and Nails in Cancer Patients: • Covers in detail the dermatologic adverse events of oncologic therapies, clinical presentations, and treatment recommendations • Enables dermatologists and other practitioners to significantly improve the care of patients with cancer • Addresses the dermatologic adverse events of cancer therapies used globally, of which a large number are found in developing countries • Emphasizes prophylactic measures – based on treatments used and type of cancer – to prevent the appearance of adverse events • Provides built-in discussions on patient education for practical counseling during therapies • Offers rapid-reference sections on topical dermatology drugs The first book to present dermatologic conditions in cancer patients and survivors in a uniform and in-depth manner, Dermatologic Principles and Practice in Oncology is ideal for oncologists, oncology nurses, and dermatologists who wish to take better care of those with adverse skin, hair, and nail conditions. |
| dupixent fda approval history: Monoclonal Antibody Production National Research Council, Institute for Laboratory Animal Research, Committee on Methods of Producing Monoclonal Antibodies, 1999-05-06 The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced. On March 26, 1998, AAVS submitted a second petition, stating that NIH failed to provide valid scientific reasons for not supporting a proposed ban. The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop. |
| dupixent fda approval history: Anticancer Treatments and Cardiotoxicity Patrizio Lancellotti, Jose L Zamorano, Maurizio Galderisi, 2016-11-11 Anticancer Treatments and Cardiotoxicity: Mechanisms, Diagnostic and Therapeutic Interventions presents cutting edge research on the adverse cardiac effects of both radiotherapy and chemotherapy, brought together by leaders in the field. Cancer treatment-related cardiotoxicity is the leading cause of treatment-associated mortality in cancer survivors and is one of the most common post-treatment issues among survivors of adult cancer. Early detection of the patients prone to developing cardiotoxicity, taking in to account the type of treatment, history and other risk factors, is essential in the fight to decrease cardiotoxic mortality. This illustrated reference describes the most effective diagnostic and imaging tools to evaluate and predict the development of cardiac dysfunction for those patients undergoing cancer treatment. In addition, new guidelines on imaging for the screening and monitoring of these patients are also presented. Anticancer Treatments and Cardiotoxicity is an essential reference for those involved in the research and treatment of cardiovascular toxicity. - Provides algorithms essential for the use of imaging, and biomarkers for the screening and monitoring of patients - Written by world-leading experts in the field of cardiotoxicity - Includes high-quality images, case studies, and test questions - Describes the most effective diagnostic and imaging tools to evaluate and predict the development of cardiac dysfunction for those patients undergoing cancer treatment |
| dupixent fda approval history: Human Monoclonal Antibodies Michael Steinitz, 2013-09-14 The introduction of monoclonal antibodies revolutionized immunology. The development of human monoclonal antibodies was inspired primarily by the enormous clinical benefits promised by these reagents which can be used as anti-inflammatory reagents, anti-tumor reagents and reagents for passive immunization in a variety of pathologies. Human Monoclonal Antibodies: Methods and Protocols presents technical protocols of cellular and molecular methods for the production, purification and application of human monoclonal antibodies, as well as review articles on related topics of human monoclonal and polyclonal antibodies. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, Human Monoclonal Antibodies: Methods and Protocols seeks to serve both professionals and novices with its well-honed methodologies which will prove invaluable in a clinical setting. |
| dupixent fda approval history: World Health Statistics 2009 World Health Organization, 2009 World Health Statistics 2009 contains WHO's annual compilation of data from its 193 member states, and includes a summary of progress towards the health-related millennium development goals and targets. This edition also contains a new section on reported cases of selected infectious diseases. It provides a comprehensive summary of the current status of national health and health systems including; mortality and burden of disease, causes of death, reported infectious diseases, health service coverage, risk factors, health systems resources, health expenditures, inequities and demographic and socioeconomic statistics. The section on inequities presents statistics on the distribution of selected health outcomes and interventions within countries, disaggregated by sex, age, urban and rural settings, wealth, and educational level. WHO presents World Health Statistics 2009 as an integral part of its ongoing effort to inform better measures of population health and national health systems. |
| dupixent fda approval history: Pharmaceutical Biotechnology Daan J. A. Crommelin, Robert D. Sindelar, 2002-11-14 The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well. |
| dupixent fda approval history: Saunders Nursing Drug Handbook 2020 Robert Kizior, Keith Hodgson, 2019-02-27 The go-to guide for students and nurses alike to promote better patient care! Saunders Nursing Drug Handbook 2020 provides you with essential information on more than 1,000 generic and 4,000 trade name drugs. This handy user-friendly guide features updated Black Box Alerts and comprehensive coverage of IV drug administration, nursing considerations, and fixed combinations. It uniquely guides you through clinical priorities in the practice setting and is organized alphabetically by generic drug name for quick reference. Detailed information for each drug distinguishes side effects and adverse reactions and lists the effect or reaction by frequency of occurrence to allow the nurse to easily identify which are most likely to occur. Plus, new drug monographs cover approximately 32 newly approved drugs by the FDA; and thoroughly updated monographs include new interactions, precautions, and alerts. - Over 1,000 generic name drugs (encompassing over 4,000 trade name drugs) are organized alphabetically with A to Z tabs to make accessing important information quick and easy. - Detailed information for each drug distinguishes side effects and adverse reactions to help you identify which are most likely to occur. - Special text treatment for high-alert drugs that pose the greatest risk for patient harm, as well as an appendix for drug names that sound alike and look alike, help promote safe drug administration. - UNIQUE! Frequently-used herb monographs and herb interactions keep you informed of the effects of commonly encountered herbs.Classifications s - ection features an overview of actions and uses for drug families.T - op 100 Drugs list helps you easily identify the most frequently administered drugs.N - ursing implications are organized in a functional nursing process framework and include headings for Baseline Assessment, Intervention/Evaluation, and Patient/Family Teaching. - Information on lifespan and disorder-related dosage variations equips you with special considerations for pediatric, geriatric, hepatic, and immune-or renal-compromised patients. - Extensively expanded IV content features a heading for IV compatibilities and expanded rates of infusion, reconstitutions, drip rates, test doses, flushing, and incompatibilities. - Fixed combinations are included in dosages of each combined drug directly within the individual monographs to help you understand different drug dose options for specific diseases. - Cross-references to the 400 top U.S. brand-name drugs are located directly in the main section of the book for easier accessibility. - Customizable and printable monographs for 100 of the most commonly used drugs and quarterly drug updates are located on the free Evolve companion site. - Therapeutic and toxic blood level information shows students the patient implications for drug administration. - Comprehensive IV Compatibility Chart foldout arms you with compatibility information for 65 intravenous drugs. - Newly approved drugs are listed in the front of the book for quick and easy access to this timely information. - Highlights the features of a sample drug monograph with callouts to help you understand how to use the book more efficiently. |
| dupixent fda approval history: Biopharmaceutics and Pharmacokinetics Considerations , 2021-07-07 Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. - Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences - Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics - Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology |
| dupixent fda approval history: Valuations of Early-Stage Companies and Disruptive Technologies Tiran Rothman, 2021-11-28 This book will serve as a practical guide for entrepreneurs and investors/advisors in constructing and understanding valuations of startups in rapidly shifting industries, including the areas of drug development, medical devices, cyber security, and renewable energy. For large companies, valuation is based on forecasts of free cash flow; in technologically-driven industries, product pipelines can represent a large part of market capitalization. The situation is even more critical for small companies committed to a single idea: all of their value is linked to a single project. Any business transaction or internal proposal to begin or terminate an R&D project in which innovative projects are being valued or exchanged requires a realistic valuation of those projects. Moreover, different projects have very different dynamics. Pharmaceuticals have very large lead times and are dependent on patents as well as out-licensing agreements. In contrast, software develops very quickly, and IP is hard to value. This book will be a guide to building appropriate valuations for companies competing in rapidly shifting industries and offering products under new business models where little precedent exists, taking both financial and behavioral issues into consideration. |
| dupixent fda approval history: Eosinophils in Health and Disease James J. Lee, Helene F. Rosenberg, 2012-11-02 Eosinophils in Health and Disease provides immunology researchers and students with a comprehensive overview of current thought and cutting-edge eosinophil research, providing chapters on basic science, disease-specific issues, therapeutics, models for study and areas of emerging importance. |
| dupixent fda approval history: Tacrolimus Ointment T. Ruzicka, S. Reitamo, 2013-04-17 Therapeutic breakthroughs in medicine are usually accompanied by a wealth of data. Often they result in a change of disease treatment paradigms. Tacrolimus ointment is the first in the new class of steroid-free Topical Immunomodulators (TIMs), and as such represents the first true breakthrough since the introduction of topical steroids more than 50 years ago for the treatment of T-cell mediated inflammatory skin diseases such as atopic dermatitis. This book gives an easy-to-read overview of the discovery and the development of Tacrolimus ointment for the treatment of atopic dermatitis. Summarising the largest clinical trial program ever conducted in dermatology for a new treatment with more than 13000 patients, it offers a detailed insight into the efficacy and safety profile of Tacrolimus ointment. Based on this large body of data and extensive personal experience, the authors offer practical and hands-on guidance for the physician as to when and how to use Tacrolimus ointment in daily practice. |
Dupixent (dupilumab) FDA Approval History - Drugs.com
Apr 23, 2025 · FDA approval history for Dupixent (dupilumab) used to treat Atopic Dermatitis, Asthma, Chronic Rhinosinusitis With Nasal Polyps, Eosinophilic Esophagitis, Prurigo …
Search Orphan Drug Designations and Approvals - Food and Drug ...
Sep 5, 2017 · Dupixent Date Designated: 09/05/2017 Orphan Designation: Treatment of eosinophilic esophagitis Orphan Designation Status: Designated/Approved Sponsor: …
Drug Trials Snapshots: DUPIXENT | FDA
Jul 7, 2020 · The FDA approved DUPIXENT based primarily on evidence from three clinical trials of 1338 participants with moderate to severe atopic dermatitis.
Dupilumab for Atopic Dermatitis: 7 Years Later - Dermatology Times
Mar 28, 2024 · In June 2022, the US FDA approved dupilumab as the first biologic medicine for children aged 6 months to 5 years with moderate-to-severe AD. 6 Dupilumab became the sole …
What is the approval history and clinical development pathway of Dupixent?
Mar 7, 2025 · The landmark approval of Dupixent came in March 2017 when regulatory authorities first approved it for the treatment of moderate-to-severe atopic dermatitis in adults whose …
Sanofi and Regeneron Announce FDA Approval of Dupixent® …
Mar 28, 2017 · The approval of Dupixent was based on data from the global LIBERTY AD clinical program, which included three randomized Phase 3 pivotal trials known as SOLO 1, SOLO 2 …
Dupixent Makes History with FDA Approval as First New CSU …
The U.S. Food and Drug Administration (FDA) approved Sanofi’s dupilumab (Dupixent) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 and older whose …
FDA Approves Dupixent® (dupilumab) as First Biologic Medicine …
Jun 7, 2022 · Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) or eosinophilic esophagitis in different …
FDA Approves DUPIXENT (Dupilumab) - accp1.org
On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved DUPIXENT (dupilumab), a human monoclonal IgG4 antibody, for the treatment of adult patients with …
Press Release: FDA approves Dupixent® (dupilumab) as first
May 20, 2019 · The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years …
Dupixent (dupilumab) FDA Approval History - Drugs.com
Apr 23, 2025 · FDA approval history for Dupixent (dupilumab) used to treat Atopic Dermatitis, Asthma, Chronic Rhinosinusitis With Nasal Polyps, Eosinophilic Esophagitis, Prurigo …
Search Orphan Drug Designations and Approvals - Food and Drug ...
Sep 5, 2017 · Dupixent Date Designated: 09/05/2017 Orphan Designation: Treatment of eosinophilic esophagitis Orphan Designation Status: Designated/Approved Sponsor: …
Drug Trials Snapshots: DUPIXENT | FDA
Jul 7, 2020 · The FDA approved DUPIXENT based primarily on evidence from three clinical trials of 1338 participants with moderate to severe atopic dermatitis.
Dupilumab for Atopic Dermatitis: 7 Years Later - Dermatology Times
Mar 28, 2024 · In June 2022, the US FDA approved dupilumab as the first biologic medicine for children aged 6 months to 5 years with moderate-to-severe AD. 6 Dupilumab became the sole …
What is the approval history and clinical development pathway of Dupixent?
Mar 7, 2025 · The landmark approval of Dupixent came in March 2017 when regulatory authorities first approved it for the treatment of moderate-to-severe atopic dermatitis in adults whose …
Sanofi and Regeneron Announce FDA Approval of Dupixent® …
Mar 28, 2017 · The approval of Dupixent was based on data from the global LIBERTY AD clinical program, which included three randomized Phase 3 pivotal trials known as SOLO 1, SOLO 2 …
Dupixent Makes History with FDA Approval as First New CSU …
The U.S. Food and Drug Administration (FDA) approved Sanofi’s dupilumab (Dupixent) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 and older whose …
FDA Approves Dupixent® (dupilumab) as First Biologic Medicine …
Jun 7, 2022 · Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) or eosinophilic esophagitis in different …
FDA Approves DUPIXENT (Dupilumab) - accp1.org
On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved DUPIXENT (dupilumab), a human monoclonal IgG4 antibody, for the treatment of adult patients with …
Press Release: FDA approves Dupixent® (dupilumab) as first
May 20, 2019 · The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years …
