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Bueno C.,Josep Carreras Leukemia Research Institute | Roldan M.,University of Granada | Anguita E.,Hospital Clinico San Carlos | Romero-Moya D.,Josep Carreras Leukemia Research Institute | And 11 more authors.
Haematologica | Year: 2014

Aplastic anemia is a life-threatening bone marrow failure disorder characterized by peripheral pancytopenia and marrow hypoplasia. The majority of cases of aplastic anemia remain idiopathic, although hematopoietic stem cell deficiency and impaired immune responses are hallmarks underlying the bone marrow failure in this condition. Mesenchymal stem/stromal cells constitute an essential component of the bone marrow hematopoietic microenvironment because of their immunomodulatory properties and their ability to support hematopoiesis, and they have been involved in the pathogenesis of several hematologic malignancies. We investigated whether bone marrow mesenchymal stem cells contribute, directly or indirectly, to the pathogenesis of aplastic anemia. We found that mesenchymal stem cell cultures can be established from the bone marrow of aplastic anemia patients and display the same phenotype and differentiation potential as their counterparts from normal bone marrow. Mesenchymal stem cells from aplastic anemia patients support the in vitro homeostasis and the in vivo repopulating function of CD34+ cells, and maintain their immunosuppressive and anti-inflammatory properties. These data demonstrate that bone marrow mesenchymal stem cells from patients with aplastic anemia do not have impaired functional and immunological properties, suggesting that they do not contribute to the pathogenesis of the disease. © 2014 Ferrata Storti Foundation.

PubMed | Health Products and Food Branch, Comprehensive Health Insights CHI, National Institute for Health and Care Excellence (NICE), Seoul National University and 13 more.
Type: Journal Article | Journal: Clinical pharmacology and therapeutics | Year: 2016

Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare.

PubMed | Health Products and Food Branch, Medical Devices Bureau and Public Health Agency of Canada
Type: | Journal: Cytometry. Part B, Clinical cytometry | Year: 2016

Background; Automation in HIV clinical flow cytometry when appropriately applied brings considerable standardisation benefits. The Canadian Immunology Quality Assessment Program (CIQAP) detected situations where operators did not manually override automated software in the event of improper output on the Epics XL and FC500 CD4 immunophenotyping platforms. The automated gating algorithm identifies lymphocytes using a double gate strategy based on CD45 x side scatter (SS) gating and a light scatter FS x SS gate known to fail with sub optimal specimens.To generate correct interpretation and results CIQAP introduced a simple protocol modification, bypassing the light scatter gate to include all cells characterized by the CD45 gate. 17 problem cases were reanalysed for both absolute and relative T-cell subsets accuracy and compared to the CIQAP group mean values. Results were found to be associated with the percentage of lymphocytes excluded by the automated light scatter gate.The modified manual protocol resolved poor performance in 14 instances out of 17 problem cases. It was found to improve accuracy when the light scatter gate excluded greater than 5% of the cells. The remaining three cases had a lymphocyte recovery of greater than 94.6% in the original automated analysis. Conclusion; There is a risk in relying solely on automated gating procedures when using the Epics XL and FC500 CD4 immunophenotyping platforms. Laboratory managers have the responsibility to intervene when required. EQA providers are equally responsible to alert the clinical laboratories of the need to update operator training to deal with stressed specimens. This article is protected by copyright. All rights reserved.

Legrand M.,Environment Canada | Feeley M.,Health Products and Food Branch | Tikhonov C.,First Nations and Inuit Health Branch | Schoen D.,Environment Canada | Li-Muller A.,Environment Canada
Canadian Journal of Public Health | Year: 2010

Exposure to methylmercury (MeHg) from fish and marine mammal consumption continues to present a public health concern. To date, developmental neurotoxicity is the most sensitive health outcome, forming the basis for health-risk assessments and the derivation of biomonitoring guidance values. This article summarizes existing Health Canada MeHg blood guidance values for general population and expands them to include a harmonized provisional interim blood guidance value of 8 μg/L based on the existing provisional Tolerable Daily Intake for children, pregnant women and women of childbearing age. Associated public health actions, according to age, sex, and level of exposure are recommended. © 2010 Canadian Public Health Association.

News Article | November 16, 2016
Site: www.marketwired.com

BROOKFIELD, WI--(Marketwired - Nov 16, 2016) - Trident Brands, Inc. ( : TDNT), an emerging growth company focused on identifying and building growth brands in dynamic consumer segments, today announced that Brain Armor has been granted a Product license under The Natural and Non-prescription Health Products Directorate (NNHPD) authorizing the sale of the product in Canada. (NNHPD) is the regulating authority for natural health products for sale in Canada. This license opens up a major new market for the Brain Armor® Brand, clearing the way for marketing and distribution activity in Canada. "Brain Armor® has been adopted by elite sports programs both at the professional and collegiate level in the United States. As a result, there is already demand among pro sports teams and athletics programs in Canada. Now that we are cleared to sell our product in Canada, we can begin to develop our business in this market. This is an exciting development," explains Trident Brands President, Don MacPhee. Brain Armor® has a strong following with professional and collegiate level sports. Its customers include major-league baseball, professional football and hockey as well as a list of NCAA Division I collegiate programs across the US. Awareness and interest in products that support brain health has been growing in Canada thanks to heightened media coverage and player safety programs in sports organizations across the country. About Brain Armor® Brain Armor® is a plant based DHA Omega-3 supplement designed for athletes to optimize cognitive and visual performance. It is NSF certified for sport, and has garnered a following with professional and collegiate athletes. Brain Armor® features life'sDHA®, a plant based DHA sourced from a sustainable process in an FDA inspected facility. DHA is especially concentrated in the gray matter of the brain, the retina of the eyes and heart tissue. DHA represents 97 percent of the omega-3s in the brain. Trident Brands holds an exclusive worldwide license from Royal DSM to market Brain Armor®. About NNHPD As part of the Health Products and Food Branch of Health Canada, the Natural and Non-prescription Health Products Directorate (NNHPD) is the regulating authority for natural health products for sale in Canada. Our role is to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity. About Trident Brands, Inc. Trident Brands, Inc. is an emerging growth company focused on identifying and building growth brands in dynamic consumer segments. The company's management team has expertise in developing and commercializing consumer products in global companies and specialty markets. Trident is currently targeting growth opportunities in brand and consolidated licenses, consumer goods such as functional foods, supplements, and beverages, life science technologies that have applications in consumer products, and intellectual property and/or licenses in recognized brand platforms. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995 that are not historical facts. These statements can be identified by the use of forward-looking terminology such as "believe," "expect," "may," "will," "should," "project," "plan," "seek," "intend," or "anticipate" or the negative thereof or comparable terminology, and include discussions of strategy, and statements about industry trends and the Company's future performance, operations, and products. Such statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the results expressed or implied by such statements. Such risks and uncertainties include, without limitation, market acceptance of the Company's forthcoming line of nutritional products; the Company's compliance with applicable Food and Drug Administration regulations; the Company's reliance on third-party contractors to mix and produce its products; the Company's ability to develop an effective marketing strategy; the Company's ability to control advertising and marketing costs; the Company's ability to develop and increase awareness of its forthcoming brands; the success of the Company's marketing focus to retail buyers; the Company's exposure to product liability claims and intellectual property claims from third parties; and the Company's reliance on the expected growth in demand for its products. For a discussion of these and other risks and uncertainties see "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's public filings with the SEC. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this press release.

Omnitrope is the first Subsequent Entry Biologic (SEB)/Similar Biotherapeutic Product (SBP) filed with Health Canada, for purposes of marketing. Health Canada is the home organization of the Regulatory Authority in Canada. As the first SEB to be filed for actual review, it presented unique challenges. While the principles for the review and approval of a SEB were laid out in a " fact sheet" there remained still a guidance to be drafted. The review of the submissions proceeded in parallel with the development of the guideline. This article will provide the details of how the final decision was arrived at and how that decision validated the principles underlying the guidance document, in the absence of direct regulations specifically addressing SEBs in Canada. © 2011.

Knezevic I.,World Health Organization | Griffiths E.,Health Products and Food Branch
Biologicals | Year: 2011

Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. This has led to a better understanding of the challenges in the regulatory evaluation of the quality, safety and efficacy of " biosimilars" , to the exchange of information between regulators, as well as to the identification of key issues. The aim of this article is to provide a brief overview of the scientific and regulatory challenges faced in developing and evaluating similar biotherapeutic products for global use. It is intended as an introduction to the series of articles in this special issue of Biologicals devoted to similar biotherepeutic products. © 2011.

Roberts K.C.,Public Health Agency of Canada | Shields M.,Health Analysis Division | De Groh M.,Public Health Agency of Canada | Aziz A.,Health Products and Food Branch | Gilbert J.-A.,Health Products and Food Branch
Health Reports | Year: 2012

Background: The 2009 to 2011 Canadian Health Measures Survey provides the most recent measured body mass index (BMI) data for children and adolescents. However, different methodologies exist for classifying BMI among children and youth. Based on the most recent World Health Organization classifi cation, nearly a third of 5- to 17-year-olds were overweight or obese. The prevalence of obesity differed between boys and girls (15.1% versus 8.0%), most notably those aged 5 to 11, among whom the percentage of obese boys (19.5%) was more than three times that of obese girls (6.3%). These estimates indicate a higher prevalence of overweight/ obesity among children than do estimates based on International Obesity Task Force cut-offs. Although the prevalence of overweight and obesity among children in Canada has not increased over the last decade, it remains a public health concern, given the tendency for excess weight to persist through to adulthood and lead to negative health outcomes.

PubMed | Health Products and Food Branch
Type: Journal Article | Journal: Chronic diseases and injuries in Canada | Year: 2014

As a result of a number of factors, the treatment of insulin-dependent diabetes has moved away from using insulin of beef or pork origin to using recombinant (biosynthetic) insulin preparations. However, some people with type 1 diabetes can manage their diabetes better using animal-sourced insulin. Despite dwindling options and decreased production, animal-sourced insulin (and pork insulin in particular) is still available on the Canadian market. This communication describes the actions taken by Health Canada with respect to the availability of animal insulin.

NEW YORK, March 02, 2017 (GLOBE NEWSWIRE) -- Blake Insomnia Therapeutics Inc. (OTCQB:BKIT) and Sajo Consulting LLC are pleased to introduce the team appointed to conduct clinical trials of its insomnia products using Blake’s proprietary Zleepax™ formula: Canadian clinical trials are planned for Q3 2017 pending approval of a New Drug Submission by the Health Products and Food Branch of Health Canada. Blake and Sajo are continuing to negotiate key terms of the joint venture. The two companies entered into an agreement about one week ago but have agreed to renegotiate certain terms. About Sajo Consulting LLC Sajo designs solutions and strategies in getting products to market faster and smarter. Their research, scientific, regulatory and operational team puts best practice standards to work while building innovative solutions for constantly evolving industries.    About Blake Insomnia Therapeutics Inc. Blake is a pharmaceutical company devoted to improving night-time and daytime quality of life for people with insomnia. The company’s patent-pending ZLX-1 compound has demonstrated efficacy without producing side effects identified as the No. 1 problem with current sleep medication. The ZLX-1 compound is marketed under the brand name, Zleepax™. Forward-Looking Statements: This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

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