PubMed Journals Articles About "Zydus Spies Opportunities Brazil Mexico Along With Biosimilars" RSS

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Showing "Zydus spies opportunities Brazil Mexico along with biosimilars" PubMed Articles 1–25 of 2,800+

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Clinical considerations for the development of biosimilars in oncology.

ABSTRACT Despite availability of biologic therapies, limited patient access to many of the most-effective cancer treatments affects overall health outcomes. To address this issue, many governments have enacted legislation for the approval of biosimilars. The term "biosimilar" refers to a biologic product that is developed to be highly similar, as opposed to identical, to a licensed biologic product (the reference or innovator product), such that, per US Food and Drug administration draft guidelines, "no cli...

Impulsive aggression in Brazil: losing opportunities to intervene.

Cancer research in Brazil - stuck in second gear?

This article describes the main issues regarding clinical cancer research in Brazil, including both the opportunities and the hurdles. Scientists and clinicians in this field had the opportunity to talk to regulatory agencies and to the Health Ministry representative at a meeting held in the State of Rio de Janeiro, Brazil, in April 2014. Our conclusions are that we do indeed have opportunities; however, we need to move forward regarding partnerships between academia and industry, increase the availability ...

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Evolution of biologicals in inflammation medicine - Biosimilars in gastroenterology, rheumatology and dermatology.

Biologicals revolutionized the therapy of chronic inflammatory diseases in gastroenterology, rheumatology and dermatology in the last decade. The first generation biologicals mainly targeted against the pro-inflammatory cytokine TNF-α. The evolution of these therapies in the last years led to the development of new antibodies and to the admission of first generation "generic" biologics - the biosimilars. Biosimilars are not a fundamental new pharmacological development for existing substances, however they...

Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens.

Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients.

Diversity and Genetic Variation among Brevipalpus Populations from Brazil and Mexico.

Brevipalpus phoenicis s.l. is an economically important vector of the Citrus leprosis virus-C (CiLV-C), one of the most severe diseases attacking citrus orchards worldwide. Effective control strategies for this mite should be designed based on basic information including its population structure, and particularly the factors that influence its dynamics. We sampled sweet orange orchards extensively in eight locations in Brazil and 12 in Mexico. Population genetic structure and genetic variation between both ...

Cancer genomes: where do we go from here?

In recent years there has been an exponential growth of knowledge of the molecular basis of cancer. In particular, the creation of important initiatives for the elucidation of the genomes of several types of cancer has allowed for the first time the creation of catalogs for most mutational events in diverse tumors, which opens up significant opportunities for oncology and public health. This review provides an overview of the progress and possible directions in Mexico.

Biosimilars in inflammatory bowel disease: ready for prime time?

The goal is to review the most recent literature about biosimilars in inflammatory bowel disease (IBD), with emphasis on controversial regulatory issues.

Biosimilars in Dermatology: Current Situation (Part II).

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this second part of the review, we will look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitutio...

Endemic Mimosa species from Mexico prefer alphaproteobacterial rhizobial symbionts.

The legume genus Mimosa has > 500 species, with two major centres of diversity, Brazil (c. 350 spp.) and Mexico (c. 100 spp.). In Brazil most species are nodulated by Burkholderia. Here we asked whether this is also true of native and endemic Mexican species. We have tested this apparent affinity for betaproteobacteria by examining the symbionts of native and endemic species of Mimosa in Mexico, especially from the central highlands where Mimosa spp. have diversified. Nodules were tested for betaproteobac...

An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins.

Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars were reviewed. Information was sourced through Internet searching and cross-referencing guidelines. As of August 2014...

Schistosomiasis in Southern Brazil 17 years after the confirmation of the first autochthonous case.

Schistosomiasis, a parasitic disease, is an important public health issue in Brazil, particularly Northern Brazil. Since the first recorded occurrence of Biomphalaria glabrata in the States of Santa Catarina and Rio Grande do Sul, it has spread to South Brazil.

Antidotes and medicines used to treat poisoning in Brazil: needs, availability and opportunities.

Antidotes and certain other drugs are essential for treating some types of poisoning. Failures in their supply can jeopardize the population's health and safety. The current study aimed to assess the availability of antidotes and other drugs used in the treatment of poisonings in Brazil. International guidelines were used as the basis for selecting 41 antidotes for analysis, none of which currently protected by patents. Of these, 27 are registered in Brazil, but 11 of these are available in inadequate forms...

A life course approach to mortality in Mexico.

Research on early life socioeconomic status (SES), education and mortality is less established in developing countries. This analysis aims to determine how SES and education are patterned across the life course and associated with adult mortality in Mexico.

The first troglomorphic species of the genus Phrynus Lamarck, 1801 (Amblypygi: Phrynidae) from Mexico.

A new troglomorphic species, Phrynus perrii sp. nov., is described from two adult females from Cueva del Naranjo, Municipio Cintalapa, Chiapas, Mexico. This is the first continental record of a troglomorphic Phrynus species, and the second troglomorphic species of the genus. With the description of this species, in Mexico there are ten extant species, plus one fossil of the genus Phrynus, and it is the seventh species of troglobitic whip spiders from Mexico, making it the country with the highest richness o...

Influenza A Viruses of Human Origin in Swine, Brazil.

The evolutionary origins of the influenza A(H1N1)pdm09 virus that caused the first outbreak of the 2009 pandemic in Mexico remain unclear, highlighting the lack of swine surveillance in Latin American countries. Although Brazil has one of the largest swine populations in the world, influenza was not thought to be endemic in Brazil's swine until the major outbreaks of influenza A(H1N1)pdm09 in 2009. Through phylogenetic analysis of whole-genome sequences of influenza viruses of the H1N1, H1N2, and H3N2 subty...

Biosimilars entering the clinic without animal studies.

The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe th...

Biosimilars: Are They Bioequivalent?

Biologics have revolutionized several areas of medical therapeutics, and dozens of them are used by millions of patients. Monoclonal antibodies are only one type of biologics, but more than 900 are now in different phases of development. These drugs are complex to make and not cheap. The market is constantly increasing, and several biosimilars (copies of biologics) are being used, while many are still waiting to become available to the public. Biosimilars are more complex than generics, and regulatory agenc...

Competition in the Age of Biosimilars.

Trends in mortality by assault in women in selected countries of Latin America, 2001-2011.

Describe the trend in deaths by assault in women in Argentina, Brazil, Chile, Colombia, and Mexico between 2001 and 2011.

Low educational level but not low income impairs the achievement of cytogenetic remission in chronic myeloid leukemia patients treated with imatinib in Brazil.

In Brazil, imatinib mesylate is supplied as the first-line therapy for chronic myeloid leukemia in the chronic phase through the public universal healthcare program, Sistema Único de Saúde (SUS). We studied the socio-demographic factors that influenced therapy success in a population in the northeast region of Brazil.

Biosimilars: The naming puzzle.

Profile of sensitization to allergens in children with atopic dermatitis assisting to Allergology Service of University Hospital, Nuevo Leon, Mexico.

Sensitization to allergens in atopic dermatitis patients is a risk factor for developing asthma and allergic rhinitis in the future,as well as an aggravating factor in the course of the disease. Recent studies have attributed the activity of the proteases of some antigens to cause a grater defect in the epithelial barrier and a more severe disease.

Adult obesity, disease and longevity in Mexico.

To obtain estimates of the effects of overweight and obesity on the incidence of type 2 diabetes (T2D) and adult mortality.

The European biosimilars market remains underdeveloped.



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