Sin categoría – Page 3 – Viglya: promoting science, honoring life

ANSM: Androcur et risque de méningiome: Mise en place d’un numéro vert pour les patients et recommandations temporaires à destination des professionnels de santé

Comme annoncé dans sa communication du 27 août 2018, l’ANSM va réunir pour la seconde fois, un comité pluridisciplinaire d’experts indépendants (CSST) le 1er octobre prochain, afin d’émettre des recommandations à destination des professionnels de santé alors que les premiers résultats d’une étude scientifique mettent en évidence une augmentation du risque de méningiome avec la durée [...]

editor2018-09-24T18:31:11+00:0024.09.2018|Sin categoría|

FDA approves first drug for neurotrophic keratitis, a rare eye disease

The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye). “While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an [...]

editor2018-08-23T21:45:05+00:0023.08.2018|Sin categoría|

EMA restricts use of Keytruda and Tecentriq in bladder cancer

Data show lower survival in some patients with low levels of cancer protein PD-L1 Early data from two clinical trials show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of the bladder and urinary tract) in patients with low levels of a protein called PD-L1. The data indicate [...]

editor2018-06-03T13:16:12+00:0004.06.2018|Sin categoría|

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018

Immediate measures agreed for Zinbryta and Xofigo while reviews are ongoing; public hearing decided for quinolone and fluoroquinolone antibiotics Contraindication for prostate cancer medicine Xofigo while review is ongoing At its March meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, [...]

editor2018-03-13T22:45:39+00:0014.03.2018|Sin categoría|

FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

The U.S. Food and Drug Administration today approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples. These tests are intended to be used as donor screening tests on [...]

editor2018-03-12T23:05:27+00:0013.03.2018|Sin categoría|

UK MHRA: Batches of Ventolin Accuhaler and Seretide Accuhaler asthma inhalers recalled

People with asthma are being asked to replace specific batches of their Ventolin Accuhaler inhalers, used for the emergency relief of asthmatic symptoms. This is due to a manufacturing issue that results in a small number of the devices not delivering the full number of doses. The Medicines and Healthcare products Regulatory Agency (MHRA) has [...]

editor2018-02-25T10:47:46+00:0026.02.2018|Sin categoría|

Infarmed: Envio de SUSAR para o Eudravigilance – Clinical Trial Module

A nova versão do Eudravigilance entrará em vigor a 22 de novembro de 2017. No âmbito da realização de ensaios clínicos, conheça o que se altera (simplifica) nas regras de notificação de Suspeitas de Reações Adversas Graves e Inesperadas (SUSAR) em Portugal, bem como o período de inatividade do sistema EV-CTM e os procedimentos a [...]

editor2017-11-07T20:59:35+00:0008.11.2017|Sin categoría|

FDA warns of potential contamination in multiple brands of drugs, dietary supplements

The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe [...]

editor2017-08-15T22:24:24+00:0016.08.2017|Sin categoría|

EMA: Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017

PRAC concludes review of safety signal for Uptravi At its April meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) completed the safety review of Uptravi (selexipag), which is used to treat pulmonary arterial hypertension, a life-threatening condition involving abnormally high blood pressure in the arteries of the lungs. The review was initiated following the deaths of [...]

editor2017-04-10T20:54:00+00:0011.04.2017|Sin categoría|

EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance covers biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline. Posted on the EMA website on 22 December 2016

editor2016-12-27T10:50:59+00:0027.12.2016|Sin categoría|

EMA: Fighting antimicrobial resistance globally

EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new antibacterial agents Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health. However, regulatory activities are only one element of the comprehensive and multifaceted response needed to encourage [...]

editor2016-12-11T18:33:50+00:0008.09.2016|Sin categoría|

WHO Pharmaceuticals Newsletter (No.3, 2016)

The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities across the world. It also provides signals based on information derived from Individual Case Safety Reports (ICSRs) available in the WHO Global ICSR database, VigiBase®. Posted on the WHO website on 30 [...]

editor2016-12-11T18:34:09+00:0004.07.2016|Pharmacovigilance, Regulatory Affairs, Sin categoría|

Infarmed: PANGEA IX: Operação internacional coordenada pela Interpol e Organização Mundial das Alfândegas combate medicamentos ilícitos

Entre 30 de maio e 7 de junho, 103 países estiveram envolvidos na operação internacional PANGEA IX, dedicada ao combate aos medicamentos falsificados e ao alerta para os perigos associados à compra destes medicamentos através da internet. A ação culminou com a detenção de 393 indivíduos e a apreensão, em todo o mundo, de 12.229.005 [...]

editor2016-12-11T18:34:19+00:0013.06.2016|Sin categoría|

EMA: Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance

Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance. Posted on the EMA website on 2 May 2016

editor2016-05-03T22:49:57+00:0004.05.2016|Sin categoría|

ANSM: Avis favorable pour l’octroi d’une AMM pour sept nouveaux médicaments: retour sur la réunion de mars 2016 du CHMP

Le Comité des médicaments à usage humain (CHMP) de l’Agence européenne des médicaments (EMA) s’est réuni du 29 mars au 1er avril 2016 à Londres. Il a rendu 7 avis favorables pour une autorisation de mise sur le marché (AMM) et 3 avis favorables pour des extensions d’indication. Avis favorable pour 7 nouvelles AMM de [...]

editor2016-12-11T18:34:45+00:0021.04.2016|Regulatory Affairs, Sin categoría|

EMA: Meeting highlights from the PRAC 14-17 March 2016

In March, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded one safety review. It also discussed three new safety reviews. For one of these, regarding the cancer medicine Zydelig, the PRAC proposed provisional measures, as a precaution, to protect patients while the medicine is being reviewed. PRAC concludes the review of the known risk of [...]

editor2016-12-11T18:34:59+00:0022.03.2016|Sin categoría|

ANSM: Avis favorable pour l’octroi d’une AMM pour six nouveaux médicaments: retour sur la réunion de janvier 2016 du CHMP

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Le Comité des médicaments à usage humain (CHMP) de l’Agence européenne des médicaments (EMA) s’est réuni du 25 au 28 janvier 2016 à [...]

editor2016-12-11T18:35:23+00:0010.02.2016|Pharmacovigilance, Regulatory Affairs, Sin categoría|

(Cas) AEMPS: Boletín mensual de la AEMPS (diciembre 2015)

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Recoge nuevos medicamentos, cambios de especial interés en medicamentos ya autorizados, información sobre seguridad y otra información de interés. En la sección [...]

editor2016-12-11T18:35:32+00:0021.01.2016|Pharmacovigilance, Sin categoría|

EMA: Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance and Pharmacovigilance System Master FileAt its December 2015 meeting, the European Medicines Agency’s (EMA) Management Board confirmed that the Article 57 database of medicines authorised in the European Union (EU) can now [...]

editor2016-12-11T18:35:42+00:0022.12.2015|Sin categoría|

The Viglya team hopes you enjoy a superlative year in 2016

editor2016-12-11T18:35:46+00:0016.12.2015|Drug Development Strategy, Partnership, Pharmacovigilance, Quality System and Audit, Regulatory Affairs, Resources, Responsibility, Sin categoría, The Company|

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