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| cosentyx fda approval history: Clinical Management of Psoriatic Arthritis and Psoriasis Eric M. Ruderman, MD, Kenneth B. Gordon, MD, 2023-10-11 Coauthored by a rheumatologist and a dermatologist, this handbook provides guidance on the diagnosis, clinical presentation, and treatment of psoriatic arthritis and psoriasis. All available medications and therapies are covered in the book, including a review of their clinical trial data, comparative effectiveness, adverse events, and prescribing information. One purpose of this handbook is to address the educational need for dermatologists who treat psoriasis to detect and refer for treatment psoriatic arthritis, and an educational need among rheumatologists to better understand and treat (or refer for treatment) psoriasis. To this end, this handbook includes a dedicated chapter on how to coordinate management of the two conditions between the two specialties. |
| cosentyx fda approval history: Moderate to Severe Psoriasis John Koo, Jashin Wu, Alice Gottlieb, Ethan Levin, Argentina Leon, 2014-03-18 Written by experts in the dermatology field, this new fourth edition of Moderate-to-Severe Psoriasis discusses the current use of biologics and other pharmacologic and phototherapy treatments for moderate-to-severe psoriasis. Illustrated with high quality color figures, this standalone text emphasizes safe and effective treatments for the psoriasis |
| cosentyx fda approval history: Advances in Psoriasis Jeffrey M. Weinberg, Mark Lebwohl, 2014-08-28 It has become increasingly clear that psoriatic disease, both of the skin and joints, can be a significant diagnostic and therapeutic challenge for the physician and a debilitating illness for the patient. Genetic and immunologic advances have increased our understanding of the pathophysiology of psoriasis and psoriatic arthritis and there is a need for practically oriented evidence based references to describe the management options open to clinicians. The speed at which developments are occurring in the field also necessitates a novel approach to keeping up with these changes in practice and the need is for a reference that that be updated regularly as the subject requires. Psoriasis is an incredibly fast-moving discipline within dermatology. Guidelines, treatment options and management all change at incredible speed. There is a requirement to provide a comprehensive reference resource to provide practical, user friendly information for the dermatology profession to aid in the decision-making process. Psoriasis is a graphical subdiscipline of medicine and therefore this will have copious illustrations. As a fast moving discipline the emphasis must be on annual updates to ensure that readers are kept up to date on the important areas of development. |
| cosentyx fda approval history: Psoriasis: Contemporary and Future Therapies, An Issue of Dermatologic Clinics, E-Book Jeffrey M. Cohen, 2024-05-28 In this issue of Dermatologic Clinics, guest editor Dr. Jeffrey M. Cohen brings his considerable expertise to the topic of Psoriasis: Contemporary and Future Therapies. Top experts in the field discuss oral therapies for psoriasis; phototherapy for psoriasis in the era of biologics; the psoriasis treatment pipeline; psoriasis comorbidities and their impact on treatment; underdiagnosis and undertreatment of traditional cardiovascular risk factors in psoriasis; and much more. - Contains 14 relevant, practice-oriented topics including biologics for psoriasis; psoriasis genetics and the impact of genetics on comorbidities and treatment; psoriasis therapies in the pediatric population; disparities in psoriasis treatment; immune checkpoint inhibitor-induced psoriasis; and more. - Provides in-depth clinical reviews on psoriasis: contemporary and future therapies, offering 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 clinically significant, topic-based reviews. |
| cosentyx 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 |
| cosentyx 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. |
| cosentyx 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. |
| cosentyx fda approval history: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
| cosentyx fda approval history: Immunopharmacology Manzoor M. Khan, 2008-12-19 During the past decades, with the introduction of the recombinant DNA, hybridoma and transgenic technologies there has been an exponential evolution in understanding the pathogenesis, diagnosis and treatment of a large number of human diseases. The technologies are evident with the development of cytokines and monoclonal antibodies as therapeutic agents and the techniques used in gene therapy. Immunopharmacology is that area of biomedical sciences where immunology, pharmacology and pathology overlap. It concerns the pharmacological approach to the immune response in physiological as well as pathological events. This goals and objectives of this textbook are to emphasize the developments in immunology and pharmacology as they relate to the modulation of immune response. The information includes the pharmacology of cytokines, monoclonal antibodies, mechanism of action of immune-suppressive agents and their relevance in tissue transplantation, therapeutic strategies for the treatment of AIDS and the techniques employed in gene therapy. The book is intended for health care professional students and graduate students in pharmacology and immunology. |
| cosentyx fda approval history: Practical Guide to Dermatology Henry W. Lim, Laurie L. Kohen, Samantha L. Schneider, Danielle Yeager, 2019-10-02 This practical manual provides a real-world educationally focused resource. It enables the reader to gain a good understanding of a range of skin diseases, their differential diagnosis and various medical and/or surgical treatment options. Topics covered include general dermatology, oncodermatology, drugs, phototherapy, pigmentary disorders, skin of color, inpatient dermatology and pediatric dermatology. Emphasis is placed on concise, practical points that one can use in clinic, with informative pearls to reinforce the key messages in each chapter. Practical Guide to Dermatology: The Henry Ford Manual systematically describes a broad range of practical concepts, diagnostic and treatment techniques involving various dermatological disciplines. It represents a valuable reference guide for practising and trainee dermatologists alike. |
| cosentyx fda approval history: Safety of Biologics Therapy Brian A. Baldo, 2016-08-12 This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences. |
| cosentyx fda approval history: Biosimilars Hiten J. Gutka, Harry Yang, Shefali Kakar, 2018-12-13 This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe. |
| cosentyx fda approval history: A Pharmacology Primer Terry P. Kenakin, 2006-10-30 The Second Edition will continue this tradition of better preparing researchers in the basics of pharmacology. In addition, new human interest material including historical facts in pharmacology will be added. A new section on therapeutics will help readers identify with diseases and drug treatments. Over 30 new figures and tables More human interest information to provide readers with historical facts on pharmacology research New section on therapeutics to help identify diseaes and drug treatments New section on new biological concepts relevant to pharmacological research (i.e., systems biology) New study sections organized with ASPET and other international pharmacology organizations New coverage of pharmacokinetics and drug disposition |
| cosentyx fda approval history: Advanced Perspectives in Cell Therapy and Correlated Immunopharmacology Wenru Su, Yong Tao, Xiaomin Zhang, Zhiming Lin, Shengping Hou, 2022-03-29 |
| cosentyx fda approval history: Mild to Moderate Psoriasis John Y. M. Koo, Ethan C. Levin, Argentina Leon, Jashin J. Wu, Mark G. Lebwohl, 2014-03-18 Using a practical and problem-focused approach, this updated, full-color Third Edition of Mild-to-Moderate Psoriasis equips dermatologists, internists, family practitioners, and residents with a state-of-the-art guide to the clinical management of mild-to-moderate psoriasis.Written by an international team of key opinion leaders, this resource explores new developments in treatments for the condition and provides clinicians with up-to-date strategies for optimal patient management. |
| cosentyx fda approval history: Restless Legs Syndrome/Willis Ekbom Disease Mauro Manconi, Diego García-Borreguero, 2017-05-07 Due to the fact that Restless Legs Syndrome/Willis-Ekbom Disease is usually a chronic condition, this book aims to provide physicians with the necessary tools for the long-term management of patients with RLS. The first part of the book addresses the various comorbidities and long-term consequences of RLS on life quality, sleep, cognitive, psychiatric and cardiovascular systems, while the second part focuses on the management of long-term treatment and the drug-induced complications in primary RLS and in special populations. Written by experts in the field, this practical resource offers a high-quality, long-term management of RLS for neurologists, sleep clinicians, pulmonologists and other healthcare professionals. |
| cosentyx fda approval history: Comorbidity in Rheumatic Diseases Yasser El Miedany, 2017-08-24 This book explores comorbidity in patients with rheumatic diseases and details both care and treatment options in standard clinical practice. Patients with rheumatic diseases are clinically complex, and the interplay of their disease activity with associated conditions may lead to increased morbidity and mortality. Recently there have been major advances in the management of rheumatic diseases, however, without addressing the potential comorbid conditions, including cardiovascular disease; pulmonary disease; and depression; outcomes remain poor. With its 19 chapters, covering the management of major rheumatic diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus , and osteoarthritis), potential comorbidities and treatment recommendations, as well as possible interactions between conditions; this book addresses the gap between textbook medicine and day to day patients' care. Authors also discuss the new hot issue of the comorbidity index, comparing the standard tools to the recently developed indices and how they can assist the rheumatologists in determining disease burden, prognosis, and comorbidity probability. This book is an ideal clinical guide and reference that enables rheumatologists, internal medicine physicians, and residents to address the full clinical expression of these rheumatic diseases with views towards prevention or early management of comorbid conditions. |
| cosentyx fda approval history: Comprehensive Dermatologic Drug Therapy Stephen E Wolverton, Jashin J. Wu, 2019-12-14 Designed with practical usability in mind, Comprehensive Dermatologic Drug Therapy, 4th Edition, helps you safely and effectively treat the skin disorders you're likely to see in your practice. Dr. Stephen E. Wolverton and new associate editor Dr. Jashin J. Wu lead a team of global experts to bring you concise, complete guidance on today's full spectrum of topical, intralesional, and systemic drugs. You'll prescribe with confidence thanks to expert coverage of which drugs to use, when to use them, and adverse effects to monitor. - Includes new drug interaction tables, drug risk profiles, and FDA guidelines, as well as two new appendices that summarize chapter questions and summarize highest-risk drug interactions. - Covers the best uses for new biologic therapeutics. - Contains new chapters covering medical decision-making principles, PDE-4 and JAK inhibitors, interleukin 17 inhibitors, interleukin 23 inhibitors, additional biologic therapeutics, and hedgehog pathway inhibitors. - Contains quick-access summaries of indications/contraindications, dosage guidelines, drug interactions, drug monitoring guidelines, adverse effects, and treatment protocols. - Features a highly detailed, disease-specific index, as well as purchase information for major drugs. - Helps you assess your knowledge and prepare for certification or recertification with about 800 review questions and answers throughout the book. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices. |
| cosentyx 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. |
| cosentyx 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. |
| cosentyx fda approval history: Management of Psoriasis Nikhil Yawalkar, 2009 Treatments for psoriasis, besides affecting the skin, may be associated with various comorbidities (for instance, depression, psoriatic arthritis, Crohn's disease and, in severe psoriasis, metabolic syndrome and cardiovascular diseases), which often presents a therapeutic challenge to physicians.Written by renowned experts, this volume gives a comprehensive overview of psoriasis and its various comorbidities. It describes the treatment modalities for mild and moderate-to-severe psoriasis, including topical, phototherapeutic and conventional systemic treatments (e.g. acitretine, methotrexate and cyclosporine), as well as biological therapies (e.g. alefacept, efalizumab, etanercept, adalimumab and infliximab). The chapters on biological therapies focus on key safety issues. Further chapters focus on such topics as the management of childhood psoriasis and psoriasis in distinctive locations, such as the scalp, face, flexures, palm/soles and nails. Finally, future therapeutic modalities, with the focus on small molecules and potential biological therapies, are discussed.This publication will make significant reading to dermatologists and all physicians dealing with psoriasis, such as general practitioners, psychiatrists, rheumatologists, cardiologists and diabetologists. |
| cosentyx fda approval history: Outside the Box Cancer Therapies Dr. Mark Stengler, 2019-05-07 Now in paperback: A thorough, cutting-edge, alternative therapy-focused exploration of Integrative Oncology care. With approximately 40 percent of men and women in the United States being diagnosed with cancer at some point in their lifetime, very few of us escape having cancer touch our lives in some way--whether it is our own life or that of a loved one. Scientific research continues to prove the benefits of nutritional and holistic therapies, yet, for the most part, these approaches to treatment still remain unexplored by the conventional medical establishment. With integrative and holistic healing being sought after and supported by more and more of the general public and medical community for various elements of everyday life, it only makes logical sense to explore these therapies with regard to one of the most prevalent causes of death of our time. In Outside the Box Cancer Therapies, naturopathic medical doctors Mark Stengler and Paul Anderson combine their expertise to focus on the most critical components of integrative oncology care. Supported by extensive research and decades of clinical experience, Dr. Stengler and Dr. Anderson thoroughly explain: • the different types of cancer and their causes • how proper nutrition can help to prevent and treat cancer • the most well-studied supplements to use with cancer treatment • cutting-edge naturopathic therapies, and • natural solutions to common problems, such as the side effects of chemotherapy and radiation With a clear and focused approach, Dr. Stengler and Dr. Anderson provide a definitive and comprehensive resource for anyone seeking to heal from cancer or a professional looking for the most cutting, up-to-date integrative approaches to treatment. |
| cosentyx fda approval history: Clariant Clareant Anna Bálint, 2012-05 Only those who are sure of their origin can know their destination. True to this principle, Anna Bálint for the first time presents the history of Clariant, the globally operating chemical company which was formed by a merger of Sandoz and Hoechst. Eyewitness accounts complete the portrait and give an informative as well as entertaining insight into the demanding task of successfully melding two distinct corporate cultures into a single strong and innovative enterprise. |
| cosentyx fda approval history: Avoid Food-Drug Interactions U.s. Food and Drug Administration, National Consumers League, 2014-07-05 What you eat and drink can affect the way your medicines work. Use this guide to alert you to possible food-drug interactions and to help you learn what you can do to prevent them. In this guide, a food-drug interaction is a change in how a medicine works caused by food, caffeine, or alcohol. A food-drug interaction can: prevent a medicine from working the way it should cause a side effect from a medicine to get worse or better cause a new side effect A medicine can also change the way your body uses a food. Any of these changes can be harmful. This guide covers interactions between some common prescription and over-the counter medicines and food, caffeine, and alcohol. These interactions come from medicine labels that FDA has approved. This guide uses the generic names of medicines, never brand names. |
| cosentyx fda approval history: NCLEX-RN Exam Cram Wilda Rinehart, Diann Sloan, Clara Hurd, 2010-11-16 1200+ Questions with Detailed Answers Covers exactly what you need to know to score higher on your NCLEX-RN® exam. Includes more than 1,250 sample test questions to help you determine whether you’re ready to take the actual exam. Our popular Cram Sheet tear card helps you remember key concepts and facts. Use our innovative Quick-Check Answer Key SystemTM to quickly find answers as you work your way through the questions. Written by Leading Nursing Experts! Wilda Rinehart has R.N., B.S.N., M.S.N., F.N.C., and F.P.N.P. degrees. Her experience includes staff nurse in surgery, labor, and delivery; public-health nurse; and family-planning nurse practitioner. She also was an instructor of surgical and obstetrical nursing. Diann Sloan has R.N., B.S.N., M.S.N., F.N.C., as well as MS. Ed. and Ph.D. in Education degrees. She has worked as a staff nurse in surgical nursing, pediatrics, and neonatal intensive care and as a pediatric nurse clinician. She has also been an instructor of pediatric and psychiatric nursing. Clara Hurd has R.N., B.S.N., M.S.N., and G.N.C. degrees. She is currently serving as an item-writing consultant with Prentice Hall Publishing. She has 31 years of experience and has worked as a staff nurse in medical-surgical nursing and the surgical intensive care unit. Ms. Hurd has taught in associate and baccalaureate nursing programs. Score Higher on the NCLEX-RN® Exam! Category: Test Preparation and Review Covers: Nursing NCLEX-RN® is a registered trademark of the National Council of State Boards of Nursing, Inc. (NCSBN), which does not sponsor or endorse this product. |
| cosentyx 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. |
| cosentyx 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. |
| cosentyx fda approval history: Biologic Therapy for Psoriasis Nicholas Brownstone, Tina Bhutani, Wilson Liao, 2022-02-17 Biologic therapy is a treatment that strives to modulate a patient's immune system to fight a given disease. In psoriasis, a skin disorder that is partly caused by a dysregulated immune system resulting in well-demarcated red areas of the skin with white scales, biologic therapy has the potential to vastly improve upon patient outcomes by minimizing the symptoms of this disease while maximizing the safety profile of the therapy. This book offers an up-to-date and comprehensive review on biologic therapy for the treatment of psoriasis. With over 10 FDA approved biologic agents for psoriasis (with more in the pipeline), confusion exists among providers regarding which agent is best for a particular patient. Chapters cover all FDA approved psoriasis biologic agents (including pipeline agents) for use in pediatric, adult, and geriatric patients. This book is unique in that it will not only cover cutting edge treatment principles based on the latest research, it will also be one of the most comprehensive reviews of psoriasis biologics in the COVID-19 era. Biologic Therapy for Psoriasis is a must-have resource for board certified dermatologists and rheumatologists, dermatology and rheumatology residents and fellows, dermatology physician assistants, nurse practitioners and medical students. The ultimate goal of this book is to improve patient care by making the busy practicing dermatology provider more adept with these particular therapies. |
| cosentyx fda approval history: Pharmacologic Therapy of Ocular Disease Scott M. Whitcup, Dimitri T. Azar, 2017-06-05 There have been major advancements in the pharmacologic treatment of eye diseases over the past decade. With newly discovered disease targets and novel approaches to deliver therapeutic compounds to the eye, patients are seeing improved outcomes. Not only are there better treatments for diseases where treatments existed, we now have effective therapy for previously untreatable and blinding eye disorders. This volume will cover the pharmacologic treatment of eye diseases from the front of the eye including eyelids, conjunctiva and cornea all the way back to the retina and optic nerve. The first section of the volume reviews general principles of ocular pharmacology, pharmacokinetics, pharmaceutical sciences, and drug delivery. In addition, the volume provides an up to date guide to the pharmacologic approach to the key eye diseases that threaten sight or ocular function. |
| cosentyx fda approval history: Goodman and Gilman's Manual of Pharmacology and Therapeutics Louis Sanford Goodman, 2008 Put the authority of Goodman & Gilman's in the palm of your hand! 5 STAR DOODY'S REVIEW! ...the most authoritative and trusted source of pharmacological information, has now spawned a portable pocket drug guide....This manual extracts the essential core drug information from the eleventh edition of the parent book, referring the reader to the online version of the parent book for historical aspects, many chemical and clinical details, and additional figures and references. This makes G & G a very useful book. This will be of use to individuals in training or practice in the fields of pharmacy, medicine, nursing, or allied health disciplines where knowledge of drug actions are important....Each chapter provides the core essential information provided in the parent book in a very readable format. Readers can use this easy to handle and read manual for essential information along with the online version of the parent book as a reference for more in-depth specific information on drugs.--Doody's Review Service The Goodman & Gilman Manual of Pharmacology and Therapeutics offers the renowned content of Goodman & Gilman's Pharmacological Basis of Therapeutics, Eleventh Edition, condensed into an ultra-handy, streamlined reference. More than just a pocket drug guide, this indispensable resource offers: A carry-along source of essential fundamental information, with all the authority of Goodman & Gilman's Pharmacological Basis of Therapeutics, Eleventh Edition The benefits of the world's leading pharmacology text in a convenient, portable format Comprehensive, yet streamlined and clinically relevant coverage of the pharmacological basis of therapeutics High-yield overview of pharmacokinetics, pharmacodynamics, and the foundations of pharmacology Expert insights into the properties, mechanisms, and uses of all the major drug classes Considerations of vital patient-specific issues |
| cosentyx fda approval history: Protein Engineering Huimin Zhao, 2021-08-23 A one-stop reference that reviews protein design strategies to applications in industrial and medical biotechnology Protein Engineering: Tools and Applications is a comprehensive resource that offers a systematic and comprehensive review of the most recent advances in the field, and contains detailed information on the methodologies and strategies behind these approaches. The authors—noted experts on the topic—explore the distinctive advantages and disadvantages of the presented methodologies and strategies in a targeted and focused manner that allows for the adaptation and implementation of the strategies for new applications. The book contains information on the directed evolution, rational design, and semi-rational design of proteins and offers a review of the most recent applications in industrial and medical biotechnology. This important book: Covers technologies and methodologies used in protein engineering Includes the strategies behind the approaches, designed to help with the adaptation and implementation of these strategies for new applications Offers a comprehensive and thorough treatment of protein engineering from primary strategies to applications in industrial and medical biotechnology Presents cutting edge advances in the continuously evolving field of protein engineering Written for students and professionals of bioengineering, biotechnology, biochemistry, Protein Engineering: Tools and Applications offers an essential resource to the design strategies in protein engineering and reviews recent applications. |
| cosentyx fda approval history: Drug-Drug Interactions for Therapeutic Biologics Honghui Zhou, Bernd Meibohm, 2013-05-10 Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics. |
| cosentyx 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. |
| cosentyx fda approval history: An Introduction to Medicinal Chemistry Graham L. Patrick, 2013-01-10 This volume provides an introduction to medicinal chemistry. It covers basic principles and background, and describes the general tactics and strategies involved in developing an effective drug. |
| cosentyx fda approval history: British Pharmaceutical Codex , 1907 |
| cosentyx fda approval history: High Density Lipoproteins Arnold von Eckardstein, Dimitris Kardassis, 2016-10-14 In this Handbook of Experimental Pharmacology on “High Density Lipoproteins – from biological understanding to clinical exploitation” contributing authors (members of COST Action BM0904/HDLnet) summarize in more than 20 chapters our current knowledge on the structure, function, metabolism and regulation of HDL in health and several diseases as well as the status of past and ongoing attempts of therapeutic exploitation. The book is of interest to researchers in academia and industry focusing on lipoprotein metabolism, cardiovascular diseases and immunology as well as clinical pharmacologists, cardiologists, diabetologists, nephrologists and other clinicians interested in metabolic or inflammatory diseases. |
| cosentyx fda approval history: Axial Spondyloarthritis and Ankylosing Spondylitis Muhammad Asim Khan, 2023-01-19 Ankylosing spondylitis (AS), currently grouped under the term axial spondyloarthritis (axSpA), is a chronic form of arthritis that causes inflammatory back pain and can gradually result in impaired spinal mobility. It can also cause eye inflammation (uveitis), arthritis of limb joints, inflammation at sites of bony attachments of tendons and ligaments (enthesitis), and associated psoriasis and inflammatory bowel disease. No cure has yet been found; however, early diagnosis and proper medical and lifestyle management are very important in reducing the risk of deformity and disability. Written by a leading expert on the subject who himself has been living with AS since age 12, this book provides clear and practical information on the clinical symptoms and signs, underlying causes, genetic predisposition, diagnosis, treatments, and impact on daily life. The combination of scientific knowledge and personal experience results in a unique book which will prove invaluable for patients and their families and friends, as well as allied health professionals and students wishing to know more about the condition. The second edition has been fully updated to cover the tremendous advancements made in the clinical recognition and effective management since the first edition in 2002. It also includes a glossary of medical terms and links to sources of further information to give patients the tools they need to understand and manage the condition effectively. |
| cosentyx fda approval history: Antibody Drug Discovery Clive R. Wood, 2012 Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology. |
| cosentyx fda approval history: The Journal of Immunology , 1983-03 |
| cosentyx fda approval history: Lyophilization of Pharmaceuticals and Biologicals Kevin R. Ward, Paul Matejtschuk, 2018-12-13 This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field. |
Plaque Psoriasis Treatment | COSENTYX® (secukinumab)
#1 PRESCRIBED. COSENTYX is the #1 prescribed ‡ biologic treatment of its kind. § ‡ Across all indications combined. § Treatment for plaque psoriasis that targets IL-17A, one of the multiple …
Psoriatic Arthritis Treatment | COSENTYX® (secukinumab)
Results fast. Relief that can last. ‡ COSENTYX is proven to help reduce symptoms of psoriatic arthritis (PsA). 3 WEEKS, 5 YEARS, #1 PRESCRIBED:
Hidradenitis Suppurativa | COSENTYX® (secukinumab)
Real relief for people with HS 50% REDUCTION OF ABSCESSES & NO INCREASE IN THESE SYMPTOMS . In the 2 clinical trials, 41% and 43% of adults taking COSENTYX 300 mg every 4 …
Secukinumab - Wikipedia
Secukinumab inhibits a member of the cytokine family, interleukin 17A, which is produced mainly by inflammatory T helper 17 cells. [11] IL17A is upregulated in serum of people with psoriasis and in …
Secukinumab (Cosentyx) Uses, Dosage, Side Effects, Warnings
May 16, 2025 · Secukinumab (Cosentyx) is an IL-17A blocker used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa …
GET THE FACTS ABOUT SAFETY AND SIDE EFFECTS - COSENTYX
COSENTYX is a medicine that affects your immune system. COSENTYX may increase your serious side effects such as: Infections COSENTYX may lower the ability of your immune system to fight …
HIGHLIGHTS OF PRESCRIBING INFORMATION ... - Food and …
TM FULL PRESCRIBING INFORMATION . 1 INDICATIONS AND USAGE COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for …
Injection Resources | COSENTYX® (secukinumab)
COSENTYX ® Connect is here for you throughout your treatment. COSENTYX ® Connect is a support program for people taking or considering COSENTYX. Sign up now for access to a full …
HOW DOES COSENTYX ® (secukinumab) WORK?
§Administered subcutaneously (under your skin). || Results shown in clinical trials using subcutaneous (SC) administration (injection under the skin). The FDA approval of the intravenous …
Cosentyx: Package Insert / Prescribing Info - Drugs.com
COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic …
How Does COSENTYX Work | COSENTYX® (secukinumab)
COSENTYX is a different kind of targeted biologic. It's the first and most prescribed treatment of its kind || and works within your body to target IL-17A. IL-17A is one of the multiple molecules in the …
label - Food and Drug Administration
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . 1.1 Plaque Psoriasis . COSENTYX ® is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in patients 6 years …
HOW DOES COSENTYX ® (secukinumab) WORK?
COSENTYX is the first FDA-approved biologic of its kind, an IL-17A blocker. What is a biologic? A biologic is a protein-based medication that is made from living sources and is taken by injection …
Secukinumab (Cosentyx®) - Johns Hopkins Arthritis Center
What is Secukinumab (Cosentyx®)? Secukinumab is a drug that reduces the signs and symptoms of psoriatic arthritis, ankylosing spondylitis, and psoriasis.
Plaque Psoriasis Treatment | COSENTYX® (secukinumab)
#1 PRESCRIBED. COSENTYX is the #1 prescribed ‡ biologic treatment of its kind. § ‡ Across all indications combined. § Treatment for plaque psoriasis that targets IL-17A, one of the multiple …
Psoriatic Arthritis Treatment | COSENTYX® (secukinumab)
Results fast. Relief that can last. ‡ COSENTYX is proven to help reduce symptoms of psoriatic arthritis (PsA). 3 WEEKS, 5 YEARS, #1 PRESCRIBED:
Hidradenitis Suppurativa | COSENTYX® (secukinumab)
Real relief for people with HS 50% REDUCTION OF ABSCESSES & NO INCREASE IN THESE SYMPTOMS . In the 2 clinical trials, 41% and 43% of adults taking COSENTYX 300 mg every …
Secukinumab - Wikipedia
Secukinumab inhibits a member of the cytokine family, interleukin 17A, which is produced mainly by inflammatory T helper 17 cells. [11] IL17A is upregulated in serum of people with psoriasis …
Secukinumab (Cosentyx) Uses, Dosage, Side Effects, Warnings
May 16, 2025 · Secukinumab (Cosentyx) is an IL-17A blocker used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa …
GET THE FACTS ABOUT SAFETY AND SIDE EFFECTS - COSENTYX
COSENTYX is a medicine that affects your immune system. COSENTYX may increase your serious side effects such as: Infections COSENTYX may lower the ability of your immune …
HIGHLIGHTS OF PRESCRIBING INFORMATION ... - Food and …
TM FULL PRESCRIBING INFORMATION . 1 INDICATIONS AND USAGE COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are …
Injection Resources | COSENTYX® (secukinumab)
COSENTYX ® Connect is here for you throughout your treatment. COSENTYX ® Connect is a support program for people taking or considering COSENTYX. Sign up now for access to a full …
HOW DOES COSENTYX ® (secukinumab) WORK?
§Administered subcutaneously (under your skin). || Results shown in clinical trials using subcutaneous (SC) administration (injection under the skin). The FDA approval of the …
Cosentyx: Package Insert / Prescribing Info - Drugs.com
COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic …
How Does COSENTYX Work | COSENTYX® (secukinumab)
COSENTYX is a different kind of targeted biologic. It's the first and most prescribed treatment of its kind || and works within your body to target IL-17A. IL-17A is one of the multiple molecules in …
label - Food and Drug Administration
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . 1.1 Plaque Psoriasis . COSENTYX ® is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in …
HOW DOES COSENTYX ® (secukinumab) WORK?
COSENTYX is the first FDA-approved biologic of its kind, an IL-17A blocker. What is a biologic? A biologic is a protein-based medication that is made from living sources and is taken by injection …
Secukinumab (Cosentyx®) - Johns Hopkins Arthritis Center
What is Secukinumab (Cosentyx®)? Secukinumab is a drug that reduces the signs and symptoms of psoriatic arthritis, ankylosing spondylitis, and psoriasis.
