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Mosunetuzumab
Mosunetuzumab, sold under the brand name Lunsumio, is a monoclonal antibody used for the treatment of follicular lymphoma. It bispecifically binds CD20 and CD3 to engage T-cells. It was developed by Genentech. The most common adverse reactions (≥20%) include cytokine release syndrome, fatigue, rash, pyrexia, and headache. The most common grade 3 to 4 laboratory abnormalities (≥10%) include decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased white blood cell count, decreased hemoglobin, and decreased platelets. Mosunetuzumab was approved for medical use in the European Union in June 2022, and in the United States in December 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses Mosunetuzumab is indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Contraindications ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CD20
B-lymphocyte antigen CD20 or CD20 is B lymphocyte cell-surface molecule. It is a 33-37 kDa non-glycosylated protein. CD20 is expressed on the surface of B-cells from the pre-B phase, the expression is lost in terminally differentiated plasma cells. CD20 is used as a therapeutical target of B-cell malignancies and autoimmune diseases. Gene In humans CD20 is encoded by the ''MS4A1'' gene localized to 11q12. The gene is 16 kbp long and consists of 8 exons. There are at least 3 mRNA transcripts (resulting from alternative splicing), that are all translated into an identical full-length CD20 protein product. Variants 1 and 2 are poorly translated due to inhibitory upstream open reading frames and stem-loop structures within their 5' untranslated regions. The relative abundance of translation-competent variant 3, as opposed to the poorly translated variants 1 and 2, may be a key determinant of CD20 levels in normal and malignant human B cells and their responses to CD20-d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Priority Review
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to develop treatments for disease indications with limited profitability. Priority review vouchers are currently earned by pharmaceutical companies for the development and approval of drugs treating neglected tropical diseases, rare pediatric diseases, and "medical countermeasures" for terrorism. The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a fee (approximately $2.8 million) to use the voucher. When seeking approval for a drug, manufacturers can apply to the FDA for priority review. This is granted when a drug is intended to treat a serious condition and would "provide a sig ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Monoclonal Antibodies For Tumors
In biology, monoclonality refers to the state of a line of cells that have been derived from a single clonal origin. Thus, "monoclonal cells" can be said to form a single clone. The term ''monoclonal'' comes . The process of replication can occur ''in vivo'', or may be stimulated ''in vitro'' for laboratory manipulations. The use of the term typically implies that there is some method to distinguish between the cells of the original population from which the single ancestral cell is derived, such as a random genetic alteration, which is inherited by the progeny. Common usages of this term include: * Monoclonal antibody: a single hybridoma cell, which by chance includes the appropriate V(D)J recombination to produce the desired antibody, is cloned to produce a large population of identical cells. In informal laboratory jargon, the monoclonal antibodies isolated from cell culture supernatants of these hybridoma clones (hybridoma lines) are simply called ''monoclonals''. * Mon ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Swissmedic
The Swiss Agency for Therapeutic Products (Swissmedic) is the Swiss surveillance authority for medicines and medical devices, registered in Bern. It began operations on 1 January 2002 as successor of ''Interkantonale Kontrollstelle für Heilmittel'' (IKS), which was itself the successor of ''Schweizerische Arzneimittelnebenwirkungszentrale'' (SANZ). Swissmedic is affiliated to the Federal Department of Home Affairs. Structure Swissmedic is a federal institution subject to public law Public law is the part of law that governs relations and affairs between legal persons and a government, between different institutions within a state, between different branches of governments, as well as relationships between persons that ... and was created by the Federal Act on Medicinal Products and Medical Devices. It is independent in organization and management and has authority over its own budget. Swissmedic has 300 full-time employees. Functions Any medical products for humans or a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Office Of Public Health
The Federal Office of Public Health (FOPH) is the Swiss federal government's centre for public health and a part of the Swiss Federal Department of Home Affairs. In addition to developing national health policy, it also represents the interests of its country within international health organizations such as the OECD or the World Health Organization. As of December 2014, FOPH employs 544 persons (443 full-time job equivalents). The 2015 budget was 193 million Swiss francs. Directorates, divisions and units The Federal Office of Public Health is headed by its director Anne Lévy (public health manager), Anne Lévy. The organisation is as follows: * Health and Accident Insurance Directorate: ** Health Care Services Division ** Insurance Supervision Division ** Health Policy Directorate ** Healthcare Professions Division ** Health Strategies Division ** Tobacco Prevention Fund ** Evaluation and Research Service * Public Health Directorate: ** National Prevention Programmes Div ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Roche
F. Hoffmann-La Roche AG, commonly known as Roche (), is a Switzerland, Swiss multinational corporation, multinational holding healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has Share (finance), shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the fifth-largest pharmaceutical company in the world by revenue and the leading provider of cancer treatments globally. In 2023, the company’s seat in Forbes Global 2000 was 76. The company owns the American biotechnology company Genentech, which is a wholly owned independent subsidiary, and the Japanese biotechnology company Chugai Pharmaceutical Co., Chugai Pharmaceuticals, as well as the United States–based companies Ventana Medical Systems, Ventana and Foundation Medicine. Roche's revenues during fiscal year 2020, were 58.32 billion Swiss francs. Descendants of the founding Hoffmann and Oeri fam ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Committee For Medicinal Products For Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal product Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...s for human use. See also * Committee for Medicinal Products for Veterinary Use References External links Committee for Medicinal Products for Human Use (CHMP) Health and the European Union {{eu-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drug
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation (if there is any) of the country. Designation of a drug as an orphan drug has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug medical research, research and development. Examples of this can be that in the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to en ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Breakthrough Therapy
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review. Requirements A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination wit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Boxed Warning
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a "box" or border around the text to emphasize its importance. The FDA can require a pharmaceutical company to place a boxed warning. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects. Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued. For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people were given th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CD3 (immunology)
CD3 ( cluster of differentiation 3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell (CD8+ naive T cells) and T helper cells (CD4+ naive T cells). It is composed of four distinct chains. In mammals, the complex contains a CD3γ chain, a CD3δ chain, and two CD3ε chains. These chains associate with the T-cell receptor (TCR) and the CD3-zeta (ζ-chain) to generate an activation signal in T lymphocytes. The TCR, CD3-zeta, and the other CD3 molecules together constitute the TCR complex. Structure The CD3γ, CD3δ, and CD3ε chains are highly related cell-surface proteins of the immunoglobulin superfamily containing a single extracellular immunoglobulin domain. A structure of the extracellular and transmembrane regions of the CD3γε/CD3δε/CD3ζζ/TCRαβ complex was solved with CryoEM, showing for the first time how the CD3 transmembrane regions enclose the TCR transmembrane regions in an open barrel. Containing ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
