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Pesquisa : E05.337.300 [Categoria DeCS]
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  1 / 12758 MEDLINE  
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[PMID]:29472192
[Au] Autor:Powers JH; Evans SR; Kesselheim AS
[Ad] Endereço:George Washington University School of Medicine, Washington, DC, USA.
[Ti] Título:Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?
[So] Source:BMJ;360:k587, 2018 02 22.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Antibacterianos/uso terapêutico
Infecções Bacterianas/tratamento farmacológico
Farmacorresistência Bacteriana Múltipla
[Mh] Termos MeSH secundário: Aprovação de Drogas
Previsões
Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Bacterial Agents)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180224
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.k587


  2 / 12758 MEDLINE  
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[PMID]:29322203
[Au] Autor:Dada R
[Ad] Endereço:Department of Oncology MBC J-64, King Faisal Specialist Hospital and Research Center, P.O. Box 40047, Jeddah, 21499, Kingdom of Saudi Arabia. rdada@kfshrc.edu.sa.
[Ti] Título:Program death inhibitors in classical Hodgkin's lymphoma: a comprehensive review.
[So] Source:Ann Hematol;97(4):555-561, 2018 Apr.
[Is] ISSN:1432-0584
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:Cancer cells are able to induce immune system tolerance through different mechanisms. Recent achievements in the understanding of tumor microenvironment, invasion, and metastasizing have contributed to accelerated drug developments and approvals. Hodgkin lymphoma (HL) cells are the minority in a lymphocyte-rich microenvironment of HL tissue. The program death-1 (PD-1)/PD-ligand-1 checkpoint is one of the known effective pathways in classical HL to escape the immune system cells. The approval of PD-1 inhibitors in different cancer types with exciting response rates is truly revolutionizing our treatment armamentarium against cancer in general and classical HL in specific. Although the disease is one of the most curable tumors, we still need better outcome with more gentle treatment, especially for relapsed and refractory (r/r) patients. In this article, we review the current literature on immune checkpoint inhibitors and currently ongoing studies with nivolumab and pembrolizumab in r/r classical HL.
[Mh] Termos MeSH primário: Antineoplásicos/uso terapêutico
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Antígeno B7-H1/antagonistas & inibidores
Doença de Hodgkin/tratamento farmacológico
Proteínas de Neoplasias/antagonistas & inibidores
Receptor de Morte Celular Programada 1/antagonistas & inibidores
[Mh] Termos MeSH secundário: Anticorpos Monoclonais/efeitos adversos
Anticorpos Monoclonais/uso terapêutico
Anticorpos Monoclonais Humanizados/efeitos adversos
Anticorpos Monoclonais Humanizados/uso terapêutico
Antineoplásicos/efeitos adversos
Antineoplásicos Imunológicos/efeitos adversos
Antineoplásicos Imunológicos/uso terapêutico
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Antígeno B7-H1/metabolismo
Aprovação de Drogas
Resistência a Múltiplos Medicamentos
Resistência a Medicamentos Antineoplásicos
Doença de Hodgkin/metabolismo
Seres Humanos
Terapia de Alvo Molecular/efeitos adversos
Proteínas de Neoplasias/metabolismo
Receptor de Morte Celular Programada 1/metabolismo
Qualidade de Vida
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Antibodies, Monoclonal, Humanized); 0 (Antineoplastic Agents); 0 (Antineoplastic Agents, Immunological); 0 (B7-H1 Antigen); 0 (CD274 protein, human); 0 (Neoplasm Proteins); 0 (PDCD1 protein, human); 0 (Programmed Cell Death 1 Receptor); 31YO63LBSN (nivolumab); DPT0O3T46P (pembrolizumab)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180112
[St] Status:MEDLINE
[do] DOI:10.1007/s00277-017-3226-0


  3 / 12758 MEDLINE  
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[PMID]:27772645
[Au] Autor:Jeng BH; Farid M; Patel SV; Schwab IR
[Ad] Endereço:Baltimore, Maryland. Electronic address: bjeng@som.umaryland.edu.
[Ti] Título:Corneal Cross-linking for Keratoconus: A Look at the Data, the Food and Drug Administration, and the Future.
[So] Source:Ophthalmology;123(11):2270-2272, 2016 11.
[Is] ISSN:1549-4713
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Reagentes para Ligações Cruzadas
Ceratocone/tratamento farmacológico
Fotoquimioterapia
Fármacos Fotossensibilizantes/uso terapêutico
Riboflavina/uso terapêutico
United States Food and Drug Administration/tendências
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Colágeno/metabolismo
Substância Própria/metabolismo
Aprovação de Drogas
Previsões
Seres Humanos
Ceratocone/metabolismo
Projetos de Pesquisa
Raios Ultravioleta
Estados Unidos
[Pt] Tipo de publicação:EDITORIAL
[Nm] Nome de substância:
0 (Cross-Linking Reagents); 0 (Photosensitizing Agents); 9007-34-5 (Collagen); TLM2976OFR (Riboflavin)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


  4 / 12758 MEDLINE  
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[PMID]:29232052
[Au] Autor:Chahal HS; Murray JS; Shimer M; Capella P; Presto R; Valdez ML; Lurie PG
[Ad] Endereço:Office of Public Health Strategy and Analysis, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.
[Ti] Título:The US Food and Drug Administration's tentative approval process and the global fight against HIV.
[So] Source:J Int AIDS Soc;20(4), 2017 Dec.
[Is] ISSN:1758-2652
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. DISCUSSION: USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. CONCLUSIONS: In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example.
[Mh] Termos MeSH primário: Fármacos Anti-HIV
Aprovação de Drogas
Infecções por HIV/tratamento farmacológico
[Mh] Termos MeSH secundário: Saúde Global
Seres Humanos
Cooperação Internacional
Tuberculose
Estados Unidos
United States Food and Drug Administration
Organização Mundial da Saúde
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-HIV Agents)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180307
[Lr] Data última revisão:
180307
[Sb] Subgrupo de revista:IM; X
[Da] Data de entrada para processamento:171213
[St] Status:MEDLINE
[do] DOI:10.1002/jia2.25019


  5 / 12758 MEDLINE  
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[PMID]:28453694
[Au] Autor:Vivot A; Jacot J; Zeitoun JD; Ravaud P; Crequit P; Porcher R
[Ad] Endereço:METHODS Team, UMR1153 Epidemiology and Statistics Sorbonne Paris Cité Research Center (CRESS), INSERM, Paris, France.
[Ti] Título:Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.
[So] Source:Ann Oncol;28(5):1111-1116, 2017 05 01.
[Is] ISSN:1569-8041
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Background: Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs. Materials and methods: We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Characteristics of drugs and approvals were obtained from publicly available FDA documents and price was evaluated according to US Medicare, US Veterans Health Administration and United Kingdom market systems. Results: The FDA approved 51 new drugs for advanced solid cancer from 2000 to 2015; we could evaluate the value of 37 drugs (73%). By the ESMO-MCBS, five drugs (14%) were grade one (the lowest), nine (24%) grade two, 10 (27%) grade three, 11 (30%) grade four and two (5%) grade five (the highest). Thus, 13 drugs (35%) showed a meaningful clinical benefit (scale levels 4 and 5). By the ASCO-VF which had a range of 3.4-67, the median drug value was 37 (interquartile range 20-52). We found no relationship between clinical benefit and drug price (P = 0.9). No characteristic of drugs and of approval was significantly associated with clinical benefit. Conclusion: Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by current scales. We found no relation between the price of drugs and benefit to society and patients.
[Mh] Termos MeSH primário: Antineoplásicos/economia
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Antineoplásicos/uso terapêutico
Análise Custo-Benefício
Aprovação de Drogas
Custos de Medicamentos
Seres Humanos
Estadiamento de Neoplasias
Neoplasias/economia
Neoplasias/patologia
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/annonc/mdx053


  6 / 12758 MEDLINE  
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[PMID]:29371221
[Au] Autor:Ross JS; Krumholz HM
[Ad] Endereço:Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
[Ti] Título:Bringing Vioxx back to market.
[So] Source:BMJ;360:k242, 2018 01 25.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Artralgia/tratamento farmacológico
Aprovação de Drogas
Lactonas/efeitos adversos
Retirada de Medicamento Baseada em Segurança
Sulfonas/efeitos adversos
[Mh] Termos MeSH secundário: Artralgia/etiologia
Hemofilia A/complicações
Seres Humanos
[Pt] Tipo de publicação:EDITORIAL; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
[Nm] Nome de substância:
0 (Lactones); 0 (Sulfones); 0QTW8Z7MCR (rofecoxib)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180127
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.k242


  7 / 12758 MEDLINE  
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[PMID]:29292944
[Au] Autor:Bradley M; Wahlgren CF
[Ad] Endereço:Institutionen för Medicin - Hudkliniken, Karolinska i Solna Stockholm, Sweden Institutionen för Medicin - Department of dermatology Stockholm, Sweden.
[Ti] Título:Nya läkemedel mot atopiskt eksem väntar på godkännande - Bättre förståelse av den molekylära sjukdomsmekanismen kan ge fler och bättre verktyg för behandling..
[So] Source:Lakartidningen;114, 2017 Nov 21.
[Is] ISSN:1652-7518
[Cp] País de publicação:Sweden
[La] Idioma:swe
[Ab] Resumo:New treatments for atopic dermatitis Atopic dermatitis is one of the most common skin disorders in Sweden. The pathogenesis is a complex counterplay between a defect skin barrier and an abnormal immune response that can be caused by genetic and/or environmental factors. Atopic dermatitis has a huge negative impact on quality of life. New and more specific treatments are under way and hopefully we will, in the near future, better treat even the more severe cases of atopic dermatitis.
[Mh] Termos MeSH primário: Dermatite Atópica/tratamento farmacológico
Fármacos Dermatológicos/uso terapêutico
[Mh] Termos MeSH secundário: Anticorpos Monoclonais/uso terapêutico
Compostos de Boro/uso terapêutico
Compostos Bicíclicos Heterocíclicos com Pontes/uso terapêutico
Dermatite Atópica/metabolismo
Dermatite Atópica/fisiopatologia
Aprovação de Drogas
Emolientes/uso terapêutico
Seres Humanos
Pele/metabolismo
Pele/fisiopatologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Boron Compounds); 0 (Bridged Bicyclo Compounds, Heterocyclic); 0 (Dermatologic Agents); 0 (Emollients)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180103
[St] Status:MEDLINE


  8 / 12758 MEDLINE  
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[PMID]:29338466
[Au] Autor:Sarva H; Henchcliffe C
[Ad] Endereço:a Parkinson's Disease and Movement Disorders Institute , Weill Cornell Medicine/New York Presbyterian Hospital , New York , NY , USA.
[Ti] Título:Valbenazine as the first and only approved treatment for adults with tardive dyskinesia.
[So] Source:Expert Rev Clin Pharmacol;11(3):209-217, 2018 Mar.
[Is] ISSN:1751-2441
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Valbenazine is a selective VMAT2 inhibitor that the FDA approved in April 2017 for the specific treatment of tardive dyskinesia (TD), a movement disorder commonly caused by dopamine blocking agents. Valbenazine acts to decrease dopamine release, reducing excessive movement found in TD. Areas covered: This drug profile reviews the development of valbenazine and the clinical trials that led to its approval as the first treatment specific to TD. The literature search was performed with the PubMed online database. Expert commentary: Two clinical trials assessing the efficacy of valbenazine have shown the reduction of antipsychotic-induced involuntary movement. No life threatening adverse effects were found. Data from a 42-week extension study demonstrated sustained response.
[Mh] Termos MeSH primário: Dopamina/metabolismo
Discinesia Tardia/tratamento farmacológico
Tetrabenazina/análogos & derivados
Valina/análogos & derivados
[Mh] Termos MeSH secundário: Adulto
Animais
Antipsicóticos/administração & dosagem
Antipsicóticos/efeitos adversos
Antipsicóticos/farmacologia
Aprovação de Drogas
Seres Humanos
Discinesia Tardia/induzido quimicamente
Tetrabenazina/efeitos adversos
Tetrabenazina/farmacologia
Tetrabenazina/uso terapêutico
Valina/efeitos adversos
Valina/farmacologia
Valina/uso terapêutico
Proteínas Vesiculares de Transporte de Monoamina/antagonistas & inibidores
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antipsychotic Agents); 0 (SLC18A2 protein, human); 0 (Vesicular Monoamine Transport Proteins); 54K37P50KH (valbenazine); HG18B9YRS7 (Valine); VTD58H1Z2X (Dopamine); Z9O08YRN8O (Tetrabenazine)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180118
[St] Status:MEDLINE
[do] DOI:10.1080/17512433.2018.1429264


  9 / 12758 MEDLINE  
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[PMID]:29209711
[Au] Autor:Hwang TJ; Darrow JJ; Kesselheim AS
[Ad] Endereço:Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.
[Ti] Título:The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
[So] Source:JAMA;318(21):2137-2138, 2017 12 05.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas/estatística & dados numéricos
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Fatores de Tempo
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171207
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.14896


  10 / 12758 MEDLINE  
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[PMID]:29183075
[Au] Autor:Van Wagoner RM; Eichner A; Bhasin S; Deuster PA; Eichner D
[Ad] Endereço:Sports Medicine Research and Testing Laboratory, Salt Lake City, Utah.
[Ti] Título:Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet.
[So] Source:JAMA;318(20):2004-2010, 2017 11 28.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Recent reports have described the increasing use of nonsteroidal selective androgen receptor modulators, which have not been approved by the US Food and Drug Administration (FDA), to enhance appearance and performance. The composition and purity of such products is not known. Objective: To determine the chemical identity and the amounts of ingredients in dietary supplements and products marketed and sold through the internet as selective androgen receptor modulators and compare the analyzed contents with product labels. Design and Setting: Web-based searches were performed from February 18, 2016, to March 25, 2016, using the Google search engine on the Chrome and Internet Explorer web browsers to identify suppliers selling selective androgen receptor modulators. The products were purchased and the identities of the compounds and their amounts were determined from April to August 2016 using chain-of-custody and World Anti-Doping Association-approved analytical procedures. Analytical findings were compared against the label information. Exposures: Products marketed and sold as selective androgen receptor modulators. Main Outcomes and Measures: Chemical identities and the amount of ingredients in each product marketed and sold as selective androgen receptor modulators. Results: Among 44 products marketed and sold as selective androgen receptor modulators, only 23 (52%) contained 1 or more selective androgen receptor modulators (Ostarine, LGD-4033, or Andarine). An additional 17 products (39%) contained another unapproved drug, including the growth hormone secretagogue ibutamoren, the peroxisome proliferator-activated receptor-δ agonist GW501516, and the Rev-ErbA agonist SR9009. Of the 44 tested products, no active compound was detected in 4 (9%) and substances not listed on the label were contained in 11 (25%). In only 18 of the 44 products (41%), the amount of active compound in the product matched that listed on the label. The amount of the compounds listed on the label differed substantially from that found by analysis in 26 of 44 products (59%). Conclusions and Relevance: In this limited investigation involving chemical analyses of 44 products marketed as selective androgen receptor modulators and sold via the internet, most products contained unapproved drugs and substances. Only 52% contained selective androgen receptor modulators and many were inaccurately labeled.
[Mh] Termos MeSH primário: Anabolizantes/química
Comércio
Rotulagem de Medicamentos
Internet
Substâncias para Melhoria do Desempenho/química
Receptores Androgênicos
[Mh] Termos MeSH secundário: Acetamidas/análise
Aminofenóis/análise
Anilidas/análise
Aprovação de Drogas
Tráfico de Drogas
Nitrilos/análise
Pirrolidinas/análise
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (4-(2-(2,2,2-trifluoro-1-hydroxyethyl)pyrrolidin-1-yl)-2-(trifluoromethyl)benzonitrile); 0 (Acetamides); 0 (Aminophenols); 0 (Anabolic Agents); 0 (Anilides); 0 (Nitriles); 0 (Performance-Enhancing Substances); 0 (Pyrrolidines); 0 (Receptors, Androgen); 7UT2HAH49H (andarine); O3571H3R8N (ostarine)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171129
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.17069



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