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 ...

Potential impact of a 9-valent HPV vaccine in HPV-related cervical disease in 4 emerging countries (Brazil, Mexico, India and China).

We estimated the potential impact of an investigational 9-valent human papillomavirus (HPV) vaccine (HPVs 6/11/16/18/31/33/45/52/58) in HPV-related cervical disease in Brazil, Mexico, India and China, to help to formulate recommendations on cervical cancer prevention and control.


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.

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...

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...

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...

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...

The role of visual markers in police victimization among structurally vulnerable persons in Tijuana, Mexico.

Law enforcement can shape HIV risk behaviours and undermine strategies aimed at curbing HIV infection. Little is known about factors that increase vulnerability to police victimization in Mexico. This study identifies correlates of police or army victimization (i.e., harassment or assault) in the past 6 months among patients seeking care at a free clinic in Tijuana, Mexico.

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.

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.

The European biosimilars market remains underdeveloped.

Electronic system of Revista Alergia México, a new challenge.

Identification of OXA-23 carbapenemases: novel variant OXA-239 in Acinetobacter baumannii ST758 clinical isolates in Mexico.

A collection of 15 carbapenem-resistance Acinetobacter baumannii clinical isolates was analysed on two tertiary hospitals in Mexico. The OXA-51 was identified in all isolates, followed by OXA-239 and OXA-58; OXA-239 is described as a new OXA-23-like allele. These carbapenemases were identified on four clonal groups, distributed between two neighbouring hospitals. Acinetobacter baumannii is poorly studied in Mexico; this situation urges the implementation of strategies to prevent its dissemination.

The rise of biosimilars in cancer care.

Twenty years of bioethics in Mexico: development and perspectives of the National Bioethics Commission.

Bioethics in Mexico has a history that reveals the vision and ethical commitment of iconic characters in the fields of health sciences and humanities, leading to the creation of the National Bioethics Commission responsible for promoting a bioethics culture in Mexico. Its development and consolidation from the higher perspective of humanism had the aim to preserve health, life and its environment, while at the same time the bases of ethics and professional practice from different perspectives have been the ...

Evaluation of a pharmacist-performed tuberculosis testing initiative in New Mexico.

To report experiences of the New Mexico pharmacist tuberculosis (TB) testing program.


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