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6.
Am J Law Med ; 47(2-3): 157-175, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34405779

RESUMO

The COVID-19 pandemic has revealed myriad and complex challenges for our national health care system spanning preparedness, response, access, costs, infrastructure, coordination, and medical innovation. These challenges implicate federal, state, and local agencies and actors, as well as international collaborative bodies. One constant throughout the pandemic has been the pressing need for safe and effective diagnostics, prophylactic vaccines, and drug treatments to counter the virus.1 Inarguably, significant problems with the multi-faceted system of drug and vaccine innovation and regulation manifested long before the COVID-19 pandemic.2 The pandemic, however, has laid bare the inextricable connections among federal funding, patents, product review and approval mechanisms, and the eventual medical products and resulting costs.


Assuntos
Produtos Biológicos/economia , COVID-19/tratamento farmacológico , Aprovação de Drogas/legislação & jurisprudência , Órgãos Governamentais , Patentes como Assunto , Terapias em Estudo/economia , Humanos , Disseminação de Informação , Propriedade Intelectual , Apoio à Pesquisa como Assunto , SARS-CoV-2 , Estados Unidos
8.
Gene ; 803: 145889, 2021 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-34371094

RESUMO

Although seen as a revolution in modern science, gene therapy has been plagued by failed clinical trials and controversial ethics in the last thirty years. Moreover, there is no comprehensive, in-depth, high-quality analysis of global gene therapy patents. This paper proposes a method to correctly retrieve patents to address the issue and use it for the patent landscape. The results show the global patent landscape of gene therapy, with the United States dominating the field, while China has emerged as a leader in recent years. For various reasons, the EU, Korea, and Japan lag in the development of patented technologies. China has edged closer to the US in both live and indefinite patents, with the Chinese Academy of Military Medical Sciences and the Chinese Academy of Sciences leading the way, surpassing primary applicants such as the US Department of Health and Human Services, the University of California, and the University of Pennsylvania. The study also reveals four broad categories of technologies that have been extensively studied in gene therapy: basic biology of the gene and diseases, diseases being treated, gene delivery methods, and potential adverse events. What is more, Adeno-Associated Virus, Retrovirus, and Lentivirus are the most prevalent gene therapy delivery vectors after 2014. The industrial development trend revealed in this paper can provide an evidence-based basis for scientific research management and decision-making.


Assuntos
Terapia Genética , Vetores Genéticos/classificação , Patentes como Assunto , China , Dependovirus/genética , União Europeia , Humanos , Japão , Lentivirus/genética , República da Coreia , Retroviridae/genética , Estados Unidos
9.
Molecules ; 26(15)2021 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-34361731

RESUMO

Strigolactones (SLs) are a class of sesquiterpenoid plant hormones that play a role in the response of plants to various biotic and abiotic stresses. When released into the rhizosphere, they are perceived by both beneficial symbiotic mycorrhizal fungi and parasitic plants. Due to their multiple roles, SLs are potentially interesting agricultural targets. Indeed, the use of SLs as agrochemicals can favor sustainable agriculture via multiple mechanisms, including shaping root architecture, promoting ideal branching, stimulating nutrient assimilation, controlling parasitic weeds, mitigating drought and enhancing mycorrhization. Moreover, over the last few years, a number of studies have shed light onto the effects exerted by SLs on human cells and on their possible applications in medicine. For example, SLs have been demonstrated to play a key role in the control of pathways related to apoptosis and inflammation. The elucidation of the molecular mechanisms behind their action has inspired further investigations into their effects on human cells and their possible uses as anti-cancer and antimicrobial agents.


Assuntos
Antineoplásicos/farmacologia , Compostos Heterocíclicos com 3 Anéis/farmacologia , Lactonas/farmacologia , Micorrizas/metabolismo , Reguladores de Crescimento de Plantas/farmacologia , Plantas/metabolismo , Sesquiterpenos/farmacologia , Adaptação Fisiológica , Agricultura/métodos , Agroquímicos/isolamento & purificação , Agroquímicos/metabolismo , Agroquímicos/farmacologia , Antibacterianos/biossíntese , Antibacterianos/isolamento & purificação , Antibacterianos/farmacologia , Antineoplásicos/isolamento & purificação , Antineoplásicos/metabolismo , Apoptose/efeitos dos fármacos , Compostos Heterocíclicos com 3 Anéis/isolamento & purificação , Compostos Heterocíclicos com 3 Anéis/metabolismo , Humanos , Inflamação/prevenção & controle , Lactonas/isolamento & purificação , Lactonas/metabolismo , Micorrizas/química , Neoplasias/tratamento farmacológico , Patentes como Assunto , Reguladores de Crescimento de Plantas/biossíntese , Reguladores de Crescimento de Plantas/isolamento & purificação , Plantas/química , Sesquiterpenos/isolamento & purificação , Sesquiterpenos/metabolismo , Estresse Fisiológico , Controle de Plantas Daninhas/métodos
10.
JAMA ; 326(5): 420-432, 2021 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-34342614

RESUMO

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.


Assuntos
Aprovação de Equipamentos/legislação & jurisprudência , Regulamentação Governamental/história , História do Século XX , História do Século XXI , Legislação Médica/história , Legislação Médica/tendências , Patentes como Assunto/história , Patentes como Assunto/legislação & jurisprudência , Vigilância de Produtos Comercializados , Software/história , Software/legislação & jurisprudência , Estados Unidos , United States Food and Drug Administration/história
11.
Biomolecules ; 11(8)2021 07 31.
Artigo em Inglês | MEDLINE | ID: mdl-34439796

RESUMO

Cancer, a fatal disease, is also one of the main causes of death worldwide. Despite various developments to prevent and treat cancer, the side effects of anticancer drugs remain a major concern. Ascorbic acid is an essential vitamin required by our bodies for normal physiological function and also has antioxidant and anticancer activity. Although the body cannot synthesize ascorbic acid, it is abundant in nature through foods and other natural sources and also exists as a nutritional food supplement. In anticancer drug development, ascorbic acid has played an important role by inhibiting the development of cancer through various mechanisms, including scavenging reactive oxygen species (ROS), selectively producing ROS and encouraging their cytotoxicity against tumour cells, preventing glucose metabolism, serving as an epigenetic regulator, and regulating the expression of HIF in tumour cells. Several ascorbic acid analogues have been produced to date for their anticancer and antioxidant activity. The current review summarizes the mechanisms behind ascorbic acid's antitumor activity, presents a compilation of its derivatives and their biological activity as anticancer agents, and discusses delivery systems such as liposomes, nanoparticles against cancer, and patents on ascorbic acid as anticancer agents.


Assuntos
Antineoplásicos/uso terapêutico , Antioxidantes/uso terapêutico , Ácido Ascórbico/uso terapêutico , Suplementos Nutricionais , Regulação Neoplásica da Expressão Gênica , Neoplasias/tratamento farmacológico , Antineoplásicos/química , Antineoplásicos/metabolismo , Antioxidantes/química , Antioxidantes/metabolismo , Ácido Ascórbico/análogos & derivados , Ácido Ascórbico/metabolismo , Biotransformação , Portadores de Fármacos/administração & dosagem , Portadores de Fármacos/química , Epigênese Genética , Transportador de Glucose Tipo 1/genética , Transportador de Glucose Tipo 1/metabolismo , Humanos , Subunidade alfa do Fator 1 Induzível por Hipóxia/genética , Subunidade alfa do Fator 1 Induzível por Hipóxia/metabolismo , Lipossomos/administração & dosagem , Lipossomos/química , Nanopartículas/administração & dosagem , Nanopartículas/química , Neoplasias/genética , Neoplasias/metabolismo , Neoplasias/patologia , Patentes como Assunto , Espécies Reativas de Oxigênio/antagonistas & inibidores , Espécies Reativas de Oxigênio/metabolismo , Transdução de Sinais , Fatores de Transcrição de p300-CBP/genética , Fatores de Transcrição de p300-CBP/metabolismo
17.
Recenti Prog Med ; 112(7): 499-503, 2021.
Artigo em Italiano | MEDLINE | ID: mdl-34263876

RESUMO

Access to vaccines against covid-19 is a very topical issue. On the one hand, we are suffering from supply problems and inadequate availability of doses both nationally and internationally. On the other hand, public health needs do not coincide with those of the market economy: the need to vaccinate the entire world population to overcome the pandemic cannot be satisfied due to market rules and limits in production processes. The result is a radical inequality in access to vaccines. We are aware of the delicate balance between health and economy: the latter cannot ignore the former. Also for this reason, the demand for greater equity in access to vaccines is growing: the race for innovation may not be hindered by a targeted relaxation of the rules on intellectual property during a pandemic health emergency.


Assuntos
Vacinas contra COVID-19/provisão & distribuição , COVID-19/prevenção & controle , Desenvolvimento de Medicamentos , Propriedade Intelectual , Pesquisa Biomédica/economia , Vacinas contra COVID-19/economia , Difusão de Inovações , Saúde Global , Disparidades em Assistência à Saúde , Humanos , Itália , Determinação de Necessidades de Cuidados de Saúde , Patentes como Assunto , Saúde Pública , Apoio à Pesquisa como Assunto/economia , Cobertura Vacinal
19.
AAPS PharmSciTech ; 22(5): 188, 2021 Jun 22.
Artigo em Inglês | MEDLINE | ID: mdl-34159427

RESUMO

Omeprazole is a widely used over-the-counter (20 mg) proton pump inhibitor, usually supplied as oral enteric-coated pellets intended to release at pH 5.5 and higher; however, it is sensitive to acidic pH. The likelihood of elevated gastric pH in practice is very high for patients; thus, the aim of this study was to investigate the effect of elevated pH on the performance of commercial omeprazole pellets. Commercial enteric-coated delayed-release pellets were tested with water uptake-weight loss (WU-WL) test at pH range between 1.2 and 4.5 in addition to "gastric" (pH 1.2 or 4.5) and "intestinal" (pH 7.4) phase dissolution tests. The range of physical characteristics of pellets was determined with a single pellet size and sedimentation time measurement, followed by the application of modified Stokes' Law equation. The coefficient of variation of pellet size and density, and volume-density determination coefficient (R2) as descriptors of coating thickness and microstructure variability, degree of ionisation of enteric polymers, aqueous solubility and molecular weight of plasticisers have been found useful to explain commercial delayed-release pellets behaviour during WU-WL and dissolution test. Investigated commercial delayed-release pellets demonstrated pH-dependent WU-WL results. "Gastric phase" dissolution testing of pellets at pH 4.5 showed the highest omeprazole degradation (48.1%) for Nosch Labs, intermediate values of dose loss (23.4% and 17.1%) for Teva and UQUIFA delayed-release pellets, respectively. Lab Liconsa pellets have been found as the least susceptible (3.2% of dose loss). Additionally, "gastric phase" dissolution test at pH 4.5 significantly influenced omeprazole release during the "intestinal phase". The risk of inadequate therapy associated with intake of investigated enteric-coated delayed-release pellets at elevated gastric pH has been found as minimal for Lab Liconsa and has increased from UQUIFA and Teva to Nosh Labs pellets.


Assuntos
Medicamentos Genéricos/química , Absorção Gastrointestinal/efeitos dos fármacos , Omeprazol/química , Patentes como Assunto , Inibidores da Bomba de Prótons/química , Preparações de Ação Retardada/química , Preparações de Ação Retardada/farmacocinética , Medicamentos Genéricos/farmacocinética , Absorção Gastrointestinal/fisiologia , Humanos , Concentração de Íons de Hidrogênio , Masculino , Omeprazol/farmacocinética , Inibidores da Bomba de Prótons/farmacocinética , Solubilidade , Comprimidos com Revestimento Entérico , Adulto Jovem
20.
Science ; 372(6548): 1345-1348, 2021 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-34140388

RESUMO

Women engage in less commercial patenting and invention than do men, which may affect what is invented. Using text analysis of all U.S. biomedical patents filed from 1976 through 2010, we found that patents with all-female inventor teams are 35% more likely than all-male teams to focus on women's health. This effect holds over decades and across research areas. We also found that female researchers are more likely to discover female-focused ideas. These findings suggest that the inventor gender gap is partially responsible for thousands of missing female-focused inventions since 1976. More generally, our findings suggest that who benefits from innovation depends on who gets to invent.


Assuntos
Invenções , Patentes como Assunto , Saúde da Mulher , Mulheres , Pesquisa Biomédica , Feminino , Humanos , Masculino , Pesquisadores
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