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| darzalex 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. |
| darzalex fda approval history: Upper Tract Urothelial Carcinoma Shahrokh F. Shariat, Evanguelos Xylinas, 2014-09-13 Upper Tract Urothelial Carcinoma represents the first book of its kind to be dedicated solely to UTUC. It's aim is to improve understanding and eventually care of a disease that is greatly understudied and underappreciated, yet commonly dealt with by many medical and urologic oncologists. The volume features new data regarding genetic susceptibility, gene expression studies and causative factors; contemporary concepts and controversies regarding diagnosis and staging of UTUC; prediction tools and their value in treatment decisions within each disease stage and patient selection and treatment options such as endoscopic management, distal ureterectomy, radical nephroureterectomy and chemotherapy. Up-to-date information regarding boundaries of surgical resection, indication and extent of lymphadenectomy is covered as well as the role of perioperative/neoadjuvant chemotherapy in patients with high-risk UTUC. Upper Tract Urothelial Carcinoma will be of great value to all Urologists, Medical Oncologists and fellows in Urologic Oncology as well as upper level residents in training in Urology and Medical Oncology. |
| darzalex 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. |
| darzalex fda approval history: Multiple Myeloma and Other Plasma Cell Neoplasms Meletios A. Dimopoulos, Thierry Facon, Evangelos Terpos, 2018-02-16 This book is a comprehensive source of up-to-date information on plasma cell neoplasms. Key features include the provision of new criteria for the diagnosis of symptomatic multiple myeloma requiring treatment and the description of novel therapies for myeloma and other plasma cell neoplasms that have only very recently been licensed by the U.S. Food and Drug Administration. Examples include lenalidomide as first-line therapy, panobinostat in combination with bortezomib plus dexamethasone for relapsed/refractory myeloma, ibrutinib for Waldenström’s macroglobulinemia, and new therapeutic regimens for systemic amyloidosis and POEMS syndrome. Information is also provided on drug combinations that have shown encouraging results and are very near to approval. Other important aspects covered in the book are the role of different imaging modalities in workup and the significance of newly acquired data relating to prognosis and minimal residual disease. Readers will find Multiple Myeloma and Other Plasma Cell Neoplasms to be a rich source of knowledge that will be invaluable in improving patient management. |
| darzalex fda approval history: The APRN and PA's Complete Guide to Prescribing Drug Therapy 2024 Mari J. Wirfs, PhD, MN, APRN, ANP-BC, FNP-BC, CNE, 2024-02-15 An unrivaled reference tool for advanced practice providers and students in clinical practice settings This concise and easy-to-read drug therapy prescribing reference provides critical information for advanced practice nurses and physician assistants in clinical practice settings who are involved in the primary care management of patients with acute, episodic, and chronic health problems, life-altering and life-threatening diseases, and needs for health promotion and disease prevention. Interspersed with clinically useful information, such as monitored laboratory values, patient teaching points, and safety information, this reference draws upon data taken directly from FDA-approved drug labels and patient medication guides, and is organized by diagnosis rather than by drug classification, to provide advanced practice practitioners with the comprehensive, concise, and up-to-date information on drug therapies that they need to help achieve positive outcomes in their daily practice. The first section of this book presents drug treatment regimens for over 700 clinical diagnoses, listed alphabetically by generic name, followed by important information required for prescription decision-making. The second section provides additional information on treatment, organized in a convenient table format. An alphabetical cross-reference index of drugs allows for easy identification of alternate drug names and their location within the text. New to this Edition: Information on over 100 new diagnoses and over 100 new generic drugs indicated for the treatment of quality of life-altering and life-threatening conditions such as chronic kidney disease, genetic diseases, mesothelioma, MS, metastatic cancers, and rare diseases. Updates on drugs used for site-specific cancers, mental health issues, and commonly diagnosed diseases such as diabetes and asthma. Details on new drug approvals including indications, treatment regimens, adverse reactions, drug-drug interactions, warnings and precautions, and use in special populations Key Features: Provides new drug treatment regimens for drugs that are first in class, novel drugs, orphan drugs, new drugs with breakthrough or fast track designation and drugs with new indications and expanded social populations. Includes drug prescribing information on diseases prevalent outside of North America, including endemic diseases with known transmission and treatment interventions. Serves advanced practice providers across the United States and internationally. Consistent with approvals and recommendations for use by the FDA. |
| darzalex fda approval history: Blood and Marrow Transplant Handbook Richard T. Maziarz, Susan Schubach Slater, 2015-04-20 This updated and expanded edition developed by the Blood and Marrow Stem Cell Transplant team at Oregon Health & Science University Knight Cancer Institute features the latest medical management guidelines and standards of care for hematopoietic stem cell transplant patients. Spanning the timeline from the initial consultation throughout the transplant process, this handbook includes indications for transplantation and donor selection, treatment guidelines for addressing complications during and after transplant, and recommendations for long-term follow up care. Concise, comprehensive, and easy-to-use, Blood and Marrow Transplant Handbook, 2nd Edition presents a multidisciplinary approach to information for physicians and advanced practice medical providers who care for transplant patients, and also residents, fellows, and other trainees. |
| darzalex fda approval history: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert, 2019-05-08 Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals. |
| darzalex 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. |
| darzalex 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. |
| darzalex fda approval history: Successful Drug Discovery, Volume 3 János Fischer, Christian Klein, Wayne E. Childers, 2018-06-05 With its focus on drugs so recently introduced that they have yet to be found in any other textbooks or general references, the information and insight found here makes this a genuinely unique handbook and reference. Following the successful approach of the previous volumes in the series, inventors and primary developers of successful drugs from both industry and academia tell the story of the drug's discovery and describe the sometimes twisted route from the first drug candidate molecule to the final marketed drug. The 11 case studies selected describe recent drugs ranging across many therapeutic fields and provide a representative cross-section of present-day drug developments. Backed by plenty of data and chemical information, the insight and experience of today's top drug creators makes this one of the most useful training manuals that a junior medicinal chemist may hope to find. The International Union of Pure and Applied Chemistry has endorsed and sponsored this project because of its high educational merit. |
| darzalex fda approval history: Transfusion Medicine, Apheresis, and Hemostasis Huy P. Pham, Lance A. Williams III, 2017-09-15 Transfusion Medicine, Apheresis, and Hemostasis: Review Questions and Case Studies is the collaborative effort that spanned a time period of 2 years and included 50 experts, many whom are national leaders in their respected fields. It also represents the passion and privilege we feel to teach the next generation of physicians in Transfusion Medicine and Apheresis. The main goal for this book is to help the readers build a solid foundation of both basic and advanced conceptual knowledge to prepare for the American Board of Pathology (ABP) certification exam in Transfusion Medicine. This book is not intended to be a substitute for textbooks, original research or review articles, and/or clinical training. Further, since the field of medicine, both from a scientific and regulatory perspective, rapidly changes, the readers are advised to continuously update their knowledge by attending national meetings and reading clinical journals. To equip the readers with the basic knowledge in critical reading and data analysis, which is an essential skill in daily medical practice, a novel chapter titled Data Interpretation in Laboratory Medicine was included in this book. In this chapter, the readers are asked to make logical conclusions based on the given data and/or statistical results. Moreover, there is also a chapter on Practical Calculations in Transfusion Medicine, Apheresis, and Hemostasis to help consolidate all the necessary formulas commonly used in daily practice for easy reference. These chapters are unique to our book and will not be found in any other currently on the market. All of the questions in this book were originally created by the authors of each chapter. Each question can either be standalone or part of a case scenario representing challenge cases in Transfusion Medicine, Apheresis, and Hemostasis. These questions often represent both rare and common clinical scenarios that the authors have seen during their clinical practice. Each question is then followed by 5 possible answers, with only one being correct (or the best answer). After the question, there is a conceptual explanation followed by a more factual explanation of the right and wrong answers. We gave the individual authors the freedom to choose how they explained the wrong answer choices. Some authors chose to be more direct (e.g. Answer A is incorrect because...), while other authors chose a more conversational style (e.g. Human resources (answer A) includes staffing, selection, orientation, training, and competency assessment of employees). This format is designed to help the student linking the conceptual and factual knowledge together to form a solid foundation for use in clinical practice. At the end of each chapter, there is a list of articles and textbooks that will prove useful to the motivated student who wishes to become an expert in the field. Another special feature to our textbook is the presence of a pre-test and post-test, which are provided to help the readers with self-assessment. As stated above, the main focus of this book is to help the readers preparing for the ABP certification exam in Transfusion Medicine. However, due to the interdisciplinary nature of the field of Transfusion Medicine, Apheresis, and Hemostasis, we believe that this book is also beneficial to and can be used by all clinicians involved in the management of complex transfusion, apheresis, and hemostasis issues, such as hematologists, anesthesiologists, surgeons, and critical care physicians. We further believe that it is a helpful guide for these specialists to prepare for their own specialty certification exam, when the topics are related to Transfusion Medicine, Apheresis, and Hemostasis. |
| darzalex fda approval history: Clinical Xenotransplantation David K. C. Cooper, Guerard Byrne, 2020-09-08 This title provides an illuminating examination of the current state of xenotransplantation – grafting or transplanting organs or tissues between members of different species – and how it might move forward into the clinic. To be sure, this is a critical topic, as a major problem that remains worldwide is an inadequate supply of organs from deceased human donors, severely limiting the number of organ transplants that can be performed each year. Based on presentations given at a major conference on xenotransplantation, this title includes important views from many leading experts who were invited to present their data and opinions on how xenotransplantation can advance into the clinic. Attention was concentrated on pig kidney and heart transplantation as it is in regard to these organs that most progress has been made. Collectively, these chapters effectively highlight the many advantages of xenotransplantation to patients with end-stage organ failure, thereby encouraging the mapping of a concrete pathway to clinical xenotransplantation. The book is organized across 22 chapters, beginning with background information on clinical and experimental xenotransplantation. Following this are discussions addressing how pigs can be genetically engineered for their organs to be resistant to the human immune response through deletion of pig xenoantigens, and the insertion of ‘protective’ human transgenes. Subsequent chapters analyze complications that arise in practice, comparing allotransplant and xenotransplant rejection. The selection of the ideal patients for the first clinical trials is discussed. Finally, the book concludes with an analysis on the regulatory, economic, and social aspects of this research, including FDA perspectives and the sensitive, psychosocial factors regarding allotransplantation and xenotransplantation. A major and timely addition to the literature, Clinical Xenotransplantation will be of great interest to all researchers, physicians, and academics from other disciplines with an interest in xenotransplantation. |
| darzalex fda approval history: Chemotherapy and Immunotherapy Guidelines and Recommendations for Practice MiKaela M. Olsen, Kristine B. LeFebvre, Suzanne L. Walker, Elizabeth Prechtel Dunphy, 2022 Oncology nursing is a unique specialty that requires continuous learning to stay up to date on cancer pathophysiology, cutting-edge drugs, and the evidence-based management of cancer and cancer treatment-related toxicities. The Oncology Nursing Society's (ONS's) second edition of Chemotherapy and Immunotherapy Guidelines and Recommendations for Practice provides nurses with the tools to understand how medications are used in cancer treatment, the effect of medication-related toxicities, and evidence-based recommendations to manage and treat these toxicities. This edition features many new cancer therapies approved since the 2019 publication. Each drug is categorized as chemotherapy, hormone, targeted, or immunotherapy agents. Extensive drug tables in the book provide nurses with tips for managing patients receiving these drugs. The expansion of oral antineoplastic therapies, alone or in combination with infusion therapy, requires that nurses review a patient's complete cancer treatment plan and consider the side effects, toxicities, and adherence to oral drugs to ensure patient tolerance and efficacy. This second edition has seen content expanded on the topic of genomics as we move forward in the world of personalized oncology. Health equity is approached with information discussing financial distress, cultural disparities, and health literacy. The latest guidelines and recommendations for treatment, symptom management, and survivorship have been integrated into this new text. This edition features a QR code, provided with the purchase of this book, to download quarterly drug updates. You will see new evidence related to many aspects of cancer nursing care incorporated into this edition, such as hypersensitivity response, safe handling of hazardous drugs, and more. The editors want to thank all of the contributors to this edition who worked tirelessly, despite a pandemic, to make this new edition a reality. This work builds on the knowledge of many generations of oncology nurses and has been used nationally and internationally to guide oncology nursing practice. We are proud to continue to serve oncology nurses worldwide with an essential resource to guide their practice-- |
| darzalex fda approval history: Highlights of Progress in Research on Cancer , 1957 |
| darzalex fda approval history: Multiple Myeloma Morie A. Gertz, S. Vincent Rajkumar, 2013-10-01 This is a comprehensive, state-of-the-art guide to the diagnosis, treatment, and biology of multiple myeloma and related plasma disorders. Edited and written by a multidisciplinary group of recognized authorities from the Mayo Clinic, it presents clear guidelines on diagnosis and therapy and covers all aspects of multiple myeloma, from molecular classification and diagnosis, to risk stratification and therapy. Closely related plasma cell disorders such as solitary plasmacytoma, Waldenstrom macroglobulinemia, and light chain amyloidosis are discussed in detail as well. The book addresses often overlooked topics, including the role of radiation therapy, vertebral augmentation, and supportive care. Our understanding of this group of disorders is developing at an unprecedented rate, and Multiple Myeloma meets the need among oncologists and hematologists for a clear, timely, and authoritative resource on their biology, diagnosis, and treatment. |
| darzalex fda approval history: Technical Manual , 1943 |
| darzalex 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. |
| darzalex 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. |
| darzalex fda approval history: Allogeneic Stem Cell Transplantation Hillard M. Lazarus, Mary J. Laughlin, 2010-03-02 Since the original publication of Allogeneic Stem Cell Transplantation: Clinical Research and Practice, Allogeneic hematopoietic stem cell transplantation (HSC) has undergone several fast-paced changes. In this second edition, the editors have focused on topics relevant to evolving knowledge in the field in order to better guide clinicians in decision-making and management of their patients, as well as help lead laboratory investigators in new directions emanating from clinical observations. Some of the most respected clinicians and scientists in this discipline have responded to the recent advances in the field by providing state-of-the-art discussions addressing these topics in the second edition. The text covers the scope of human genomic variation, the methods of HLA typing and interpretation of high-resolution HLA results. Comprehensive and up-to-date, Allogeneic Stem Cell Transplantation: Clinical Research and Practice, Second Edition offers concise advice on today's best clinical practice and will be of significant benefit to all clinicians and researchers in allogeneic HSC transplantation. |
| darzalex fda approval history: Lipid Nanocarriers for Drug Targeting Alexandru Mihai Grumezescu, 2018-04-16 Lipid Nanocarriers for Drug Targeting presents recent advances in the area of lipid nanocarriers. The book focuses on cationic lipid nanocarriers, solid lipid nanocarriers, liposomes, thermosensitive vesicles, and cubosomes, with applications in phototherapy, cosmetic and others. As the first book related to lipid nanocarriers and their direct implication in pharmaceutical nanotechnology, this important reference resource is ideal for biomaterials scientists and those working in the medical and pharmaceutical industries that want to learn more on how lipids can be used to create more effective drug delivery systems. - Highlights the most commonly used types of lipid nanocarriers and explains how they are applied in pharmacy - Shows how lipid nanocarriers are used in different types of treatment, including oral medicine, skin repair and cancer treatment - Assesses the pros and cons of using different lipid nanocarriers for different therapies |
| darzalex fda approval history: Intellectual Property Wen De Keesee, 2021-09 Intellectual Property (IP) is the bedrock on which the development of new treatments and cures is built. IP is critical to improving patient care, spurring economic growth and strengthening an innovation economy. The biopharmaceutical industry is directly responsible for more than 850,000 jobs and a total of 4.4 million total jobs (direct, indirect and induced). 7000 new medicines are in development around the world 4,500 industry sponsored clinical trials are currently underway 90% of all clinical trials are led by the biopharmaceutical industry $1.1 TRILLION DOLLARS – total value of goods and services supported by the biopharmaceutical sector. Biotech Stocks are on fire! Potentially 100’s of new little biotech companies will develop new generations of medicines and medical devices while creating vast numbers of new millionaires. The Biotech “Gold Rush” is On! What are you waiting for? |
| darzalex fda approval history: Bioinspired and Biomimetic Materials for Drug Delivery Md Nurunnabi, 2021-07-15 Bioinspired and Biomimetic Materials for Drug Delivery delves into the potential of bioinspired materials in drug delivery, detailing each material type and its latest developments. In the last decade, biomimetic and bioinspired materials and technology has garnered increased attention in drug delivery research. Various material types including polymer, small molecular, protein, peptide, cholesterol, polysaccharide, nano-crystal and hybrid materials are widely considered in drug delivery research. However, biomimetic and bioinspired materials and technology have shown promising results for use in therapeutics, due to their high biocompatibility and reduced immunogenicity. Such materials include dopamine, extracellular exosome, bile acids, ionic liquids, and red blood cell. This book covers each of these materials in detail, reviewing their potential and usage in drug delivery. As such, this book will be a great source of information for biomaterials scientists, biomedical engineers and those working in pharmaceutical research. - Explores latest developments for a broad range of bioinspired and biomimetic materials for drug delivery applications - Helps researchers overcome the challenges of biocompatibility and immunogenicity in drug development - Provides both theoretical and practical knowledge in regards to materials characterization and use in a range of drugs |
| darzalex fda approval history: Advancing the Science of Cancer in Latinos Amelie G. Ramirez, Edward J. Trapido, 2019-11-21 This open access book gives an overview of the sessions, panel discussions, and outcomes of the Advancing the Science of Cancer in Latinos conference, held in February 2018 in San Antonio, Texas, USA, and hosted by the Mays Cancer Center and the Institute for Health Promotion Research at UT Health San Antonio. Latinos – the largest, youngest, and fastest-growing minority group in the United States – are expected to face a 142% rise in cancer cases in coming years. Although there has been substantial advancement in cancer prevention, screening, diagnosis, and treatment over the past few decades, addressing Latino cancer health disparities has not nearly kept pace with progress. The diverse and dynamic group of speakers and panelists brought together at the Advancing the Science of Cancer in Latinos conference provided in-depth insights as well as progress and actionable goals for Latino-focused basic science research, clinical best practices, community interventions, and what can be done by way of prevention, screening, diagnosis, and treatment of cancer in Latinos. These insights have been translated into the chapters included in this compendium; the chapters summarize the presentations and include current knowledge in the specific topic areas, identified gaps, and top priority areas for future cancer research in Latinos. Topics included among the chapters: Colorectal cancer disparities in Latinos: Genes vs. Environment Breast cancer risk and mortality in women of Latin American origin Differential cancer risk in Latinos: The role of diet Overcoming barriers for Latinos on cancer clinical trials Es tiempo: Engaging Latinas in cervical cancer research Emerging policies in U.S. health care Advancing the Science of Cancer in Latinos proves to be an indispensable resource offering key insights into actionable targets for basic science research, suggestions for clinical best practices and community interventions, and novel strategies and advocacy opportunities to reduce health disparities in Latino communities. It will find an engaged audience among researchers, academics, physicians and other healthcare professionals, patient advocates, students, and others with an interest in the broad field of Latino cancer. |
| darzalex fda approval history: The History of Cyclodextrins Grégorio Crini, Sophie Fourmentin, Eric Lichtfouse, 2020-09-29 This book presents the historical development of Cyclodextrins by scientists who have made outstanding contribution to the field. Cyclodextrins are safe, cage-like molecules that have found major applications in many industrial sectors such as medicine, food, agriculture, environment and chemistry. |
| darzalex fda approval history: Centers of the Cancer Universe Donald L. Trump, Eric T. Rosenthal, 2021-10-11 A 2022 Choice Reviews Outstanding Academic Title An important history of the development of cancer centers of excellence and the revolution in cancer treatment. In the 1960s a coalition of concerned citizens, scientists and politicians joined forces to convince the federal government to focus its efforts on conquering cancer. The National Cancer Act of 1971 resulted and was signed into law on December 23, 1971 by President Nixon. The national “War on Cancer,” was declared with some leaders naively arguing that the disease would be conquered by the nation’s bicentennial—a mere five years in the future. Over the next five decades scientific discoveries demonstrated the great complexity of what had formerly been thought of as a single disease – with the advent of the genetic characterization of cancers, it is now recognized that there are almost an infinite number of cancers as defined by their many genetic mutations. The National Cancer Act established the infrastructure for the designation of centers by the National Cancer Institute (NCI) and these centers have evolved into models of multidisciplinary, collaborative cancer research, treatment and prevention contributing to a reduction in cancer mortality and increase in quality of life and survival that has translated into more than 17 million cancer survivors in the United States in 2021. Centers of the Cancer Universe: A Half-Century of Progress Against Cancer tells the story of how cancer research was not front and center at most universities and research institutions before the National Cancer Act of 1971, and why many physicians were reluctant even to treat patients with cancer in the early 20th century. It follows the behind-the-scenes lobbying, resistance and negotiating that preceded signing the Act into law, and how the cancer centers of today came to fruition, and shaped how cancer research, clinical trials and treatment would be conducted. |
| darzalex fda approval history: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
| darzalex 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. |
| darzalex fda approval history: Phytochemistry: An in-silico and in-vitro Update Shashank Kumar, Chukwuebuka Egbuna, 2019-06-25 Phytochemistry is the branch of science that deals with the study of plant-derived chemicals or compounds, which are also known as phytochemicals or plant-derived secondary metabolites. Plants are known to produce phytochemicals that are essential for their growth and reproduction, as they protect them from insects, pathogens, and herbivores. Some of the major groups of plant-derived secondary metabolites are phenolics, flavonoids, terpenoids, alkaloids, tannin etc. Plant-derived phytochemicals are pharmacologically active and have the potential to cure various human diseases and disorders. Natural plant products have been known for their medicinal properties for untold years, and form the basis of several medicinal systems such as Chinese, Unani, and Ayurvedic Medicine. This book offers an essential introduction to phytochemicals and their synthetic analogues. It discusses various in silico approaches used to identify pharmacologically active phytochemicals and their biological activities, as well as in vitro and in vivo models/assays that have been utilized for the pharmacological profiling of plant-derived products to combat cancer, diabetes, cardiovascular diseases and neurological disorders. The intended audience includes upper-level undergraduate and graduate students; researchers and scientists from the pharmaceutical/food chemistry/nutrition sciences/biochemistry, and clinical biochemistry fields; and medical students. Sharing the latest findings, the book will familiarize these readers with the concepts, chemistry, and tremendous potential of phytochemistry. |
| darzalex fda approval history: Clinical Oncology Martin D. Abeloff, 2000 A must-have reference, this new edition provides practical information on treatment guidelines, details of diagnosis and therapy, and personal recommendations on patient management from experts in the field. Consistently formatted chapters allow for a user-friendly presentation for quick access of key information by the practicing clinician. Completely updated, this new edition includes all of the latest developments in treatment strategies of medical, surgical and radiation oncologists. |
| darzalex fda approval history: Evidence-Based Medicine and the Changing Nature of Health Care Institute of Medicine, LeighAnne M. Olsen, Elizabeth G. Nabel, J. Michael McGinnis, Mark B. McClellan, 2008-09-06 Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership. |
| darzalex fda approval history: Deep Suppression , 2021-07-31 Suicide is never the solution. Depression is a disease of thoughts and Deep Suppression is a book about a boy, Levi Owen, suffering from chronic depression and how he overcomes the deadly disease with the help and guidance of his friend, Ethan Brown. Unaware that his words saved Ethan from the same, Levi goes on the journey of surviving within himself, overcoming his suicidal thoughts, giving life a second chance, accepting himself, curing and finally thanking himself for not giving up. |
| darzalex fda approval history: The Truth about Cancer Ty M. Bollinger, 2018-10-09 Cancer touches more lives than you may think. According to the World Health Organization, one out of three women alive today, and one out of two men, will face a cancer diagnosis in their lifetime.To Ty Bollinger, this isn’t just a statistic. It’s personal. After losing seven members of his family to cancer over the course of a decade, Ty set out on a global quest to learn as much as he possibly could about cancer treatments and the medical industry that surrounds the disease. He has written this book to share what he’s uncovered—some of which may shock you—and to give you new resources for coping with cancer in your life or the life of someone you love.As Ty explains, there are many methods we can access to treat and prevent cancer that go well beyond chemotherapy, radiation, and surgery; we just don’t know about them. The Truth about Cancer delves into the history of medicine—all the way back to Hippocrates’s credo of do no harm—as well as cutting-edge research showing the efficacy of dozens of unconventional cancer treatments that are helping patients around the globe. You’ll read about the politics of cancer; facts and myths about its causes (a family history is only part of the picture); and the range of tools available to diagnose and treat it.If you’re facing a cancer diagnosis right now, this book may help you and your health-care provider make choices about your next steps. If you’re already undergoing conventional treatment, it may help you support your health during the course of chemo or radiation. If you’re a health-care provider and want to learn all you can to help your patients, it will expand your horizons and inspire you with true stories of successful healing. And if you just want to see cancer in a new light, it will open your eyes. |
| darzalex fda approval history: Oncology Tumors & Treatment Stanley B. Burns, 2004 A photographic history of oncology, from the collection of renowned physician and historian Stanley B. Burns. |
| darzalex fda approval history: Surgery of the Breast Scott L. Spear, Y. Maurice Nahabedian, This heavily illustrated two-volume atlas is the most comprehensive how-to reference on surgery of the breast. The world's leading surgeons describe and demonstrate the most advanced and successful techniques for all types of general surgery, aesthetic, and reconstructive procedures--oncologic management of breast disease, breast reconstruction, reduction mammoplasty and mastopexy, and augmentation mammoplasty. The text is illustrated throughout with over 4,100 drawings and full-color preoperative, intraoperative, and postoperative photographs. Editorial comments at the end of each chapter provide an alternative perspective and address current controversies. This thoroughly updated Third Edition features a greatly expanded section on augmentation mammoplasty. Other new chapters cover deep inferior epigastric perforator flap breast reconstruction, skin preserving delayed breast reconstruction, and nipple-sparing mastectomy. Coverage also includes new information on managing oncoplastic surgery, surveillance following breast reconstruction, reconstruction following tumor recurrence, and the role of stem cells--Provided by publisher. |
| darzalex fda approval history: Pharmacotherapy Principles and Practice, Sixth Edition Marie A. Chisholm-Burns, Terry L. Schwinghammer, Patrick M. Malone, Jill M. Kolesar, Kelly C Lee, P. Brandon Bookstaver, 2022-02-04 All the main concepts from the landmark Pharmacotherapy: A Pathophysiologic Approach—distilled down to a concise, clinically focused, full-color resource Providing a solid evidence-based approach, Pharmacotherapy Principles & Practice, Sixth Edition explains how to design, implement, monitor, and evaluate medication therapy. You’ll gain an in-depth understanding of the underlying principles of the pharmacotherapy of disease―and their practical application. Pharmacotherapy Principles & Practice includes chapters on geriatrics, pediatrics, and palliative care. Each of the subsequent disease-based chapters covers disease epidemiology, etiology, pathophysiology, clinical presentation and diagnosis, nonpharmacologic therapy, followed by therapeutic recommendations for medication selection, desired outcomes, dosing, and patient monitoring. Features Chapters are written/reviewed by pharmacists, NPs, PAs, and physicians considered authorities in their fields Learning objectives with associated content identified with a margin rule Disorder-based organization makes finding answers quick and easy Surveys the full range of organ system disorders treated in pharmacy practice Knowledge-building boxed features within chapters cover Clinical Presentation & Diagnosis, Patient Encounters, and Patient Care and Monitoring Guidelines Standardized chapter format Laboratory values are presented in conventional and Systemé International units Key concepts are indicated in text with numbered icons Content on cultural competency Glossary Online Learning Center |
| darzalex fda approval history: Cell-wide Metabolic Alterations Associated with Malignancy , 2014-06-16 This new volume of Methods in Enzymology continues the legacy of this premier serial with quality chapters authored by leaders in the field. This volume covers research methods providing a a theoretical overview on metabolic alterations of cancer cells and a series of protocols that can be employed to study oncometabolism, in vitro, ex vivo and in vivo. Malignant cells exhibit metabolic changes when compared to their normal counterparts, owing to both genetic and epigenetic alterations. Although such a metabolic rewiring has recently been indicated as yet another general hallmark of cancer, accumulating evidence suggests that the metabolic alterations of each neoplasm rather represent a molecular signature that intimately accompanies, and hence cannot be severed from, all facets of malignant transformation. |
| darzalex fda approval history: Indolent Lymphomas Martin Dreyling, Marco Ladetto, 2022-02-11 This book provides a comprehensive overview of current treatment strategies in indolent lymphomas, the clinical management of which continues to pose significant challenges for the general oncologist despite the tremendous progress in diagnosis, evaluation of risk factors, and molecular targeted approaches. Experts in the field from around the world describe the histomorphology in a clinically relevant manner, consider the role of risk factors in detail, and discuss the full spectrum of therapeutic approaches. Special emphasis is placed on the translation of molecular science into clinical care, and a disease-specific algorithm is proposed for each entity. The coverage encompasses follicular lymphoma, MALT, nodal marginal zone lymphoma, splenic marginal zone lymphoma, Waldenström’s macroglobulinemia, hairy cell leukemia, chronic lymphocytic leukemia, mycosis fungoides, large granular lymphocytic leukemia, and also mantle cell lymphoma. The book will be an excellent resource for experienced and inexperienced practitioners alike. |
Darzalex: Uses, Dosage & Side Effects - Drugs.com
Nov 24, 2024 · Darzalex ( daratumumab) is used to treat multiple myeloma to help slow or stop cancer from progressing. Darzalex is a targeted cancer medicine that binds to a protein on the …
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Learn about adult treatment with DARZALEX® and DARZALEX FASPRO®. See Full Prescribing & Safety Information.
Darzalex (daratumumab): Side effects, cost, dosage, and more
Feb 24, 2025 · Darzalex is a brand-name prescription drug used to treat multiple myeloma in adults. Learn about side effects, price, how it works, and more.
Dosage and Administration of DARZALEX - Infusion Rate
Oct 14, 2024 · The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an intravenous infusion according to the following schedule for the regimens …
Darzalex Monotherapy OK'd for Smoldering Multiple Myeloma
Jun 20, 2025 · The EMA has extended the indications for Darzalex (daratumumab) to the treatment of adults at high risk of developing multiple myeloma.
Daratumumab (DARZALEX) | FDA
On November 21, 2016, the U.S. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or …
DARZALEX® (daratumumab) receives the first positive CHMP …
BEERSE, BELGIUM, June 20, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the Committee for Medicinal Products for …
Darzalex (Daratumumab Intravenous Injection): Side Effects, Uses ...
May 29, 2025 · What Is Darzalex? Darzalex (daratumumab) injection is a human CD38-directed monoclonal antibody indicated for the treatment of patients with multiple myeloma who have …
DARZALEX (daratumumab) - International Myeloma Foundation
Jan 25, 2025 · Darzalex® (daratumumab) is a laboratory-made monoclonal antibody designed to function like a naturally occurring antibody. It targets a specific single protein on the surface of …
Darzalex Patient Tips: 7 things you should know - Drugs.com
Oct 5, 2023 · Darzalex is a brand (trade) name for daratumumab injection which may be used to treat adults with multiple myeloma who meet certain criteria. It is usually used in combination …
UOL 战队（Unicorns Of Love） - 知乎
UOL战队（Unicorns Of Love）是一支来自大洋洲赛区的电竞队伍，曾在历届入围赛中表现出色，但在S11赛季遭遇淘汰。
有人读过ACCA的UOL线下项目吗？ - 知乎
而UOL是2016年才开始设立的 一、ACCA硕士学历UOL介绍： 从2016年起，ACCA学员将有机会不出国门拿到海外名校会计硕士!专业会计硕士指的是Master of Professional Accounting，简 …
伦敦大学到底是什么? - 知乎
关于评论区说至少要排到200开外的问题在这里认真回复一下，也方便以后看到的人分清楚这些容易混淆的概念 首先， UOL集团某些下属学院（这些学院排名往往比较低）没有权力发独立证 …
伦敦大学文凭在国内的认可度如何？ - 知乎
Aug 30, 2021 · 2.从国际来看： 伦敦大学UOL，是英国的老牌名校，世界上最具影响力的“公立联邦制大学”，其中包含著名的“金三角名校”：UCL、KCL、LSE。 英国G5超级精英大学的帝国理 …
读新加坡SIM的UOL 最后一年可以转本校就读嘛？ - 知乎
读UOL只能在第二年转去英国大学，LSE的话要你的成绩非常优秀，但是普通birmingham 经济学 只需要gpa 2.75-2.8就行了，为什么会这样呢?UOL第一年读的课程，有一部分是这些英国大 …
ACCA伦敦大学uol硕士学位 国内就业认可度高吗，和ucl硕士有什 …
Oct 12, 2021 · ACCA伦敦大学uol硕士学位 国内就业认可度高吗，和ucl硕士有什么区别，和985研究生比怎样？ 某下游985本科在校生，最近ACCA在学，想把握以后的方向考研还是出国，看 …
伦敦大学（UoL）的作用是什么；各学院加入或退出是出于什么考 …
伦敦大学（UoL）的作用是什么；各学院加入或退出是出于什么考量？ 如题。 伦敦大学（Univ. of London）是多个学校组成的联合体，学校可以选择加入或退出，每个学校是行政独立的。 这 …
sim与uol合作的本科课程能否申请NUS/NTU的研究生? - 知乎
Dec 16, 2020 · SIM读UOL课程的学生每年都有录取国大， 南大，官大硕士的学生，主要看本科阶段的成绩如何。 国内一般称硕士为研究生，考硕士称为考研，实际毕业拿到的学位就是硕士 …
UCL宿舍揭秘—— Nutford House - 知乎
Nutford House是隶属于UoL伦敦大学联盟的一栋包餐宿舍，提供给UCL的本科生小伙伴们申请，与UCL有大概30分钟的步行距离。Nutford House位于Marylebone区的中心，坐拥伦敦1区黄金 …
如何选UCL的宿舍？ - 知乎
Apr 14, 2020 · 表格中UoL Halls的价格为19-20学年价格，官网还未更新至20-21，每年的价格基本和往年持平，通常会有微小的上涨。这些UoL Halls都需要通过UCL的宿舍申请系统进行申 …
