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UK MHRA: Pharmacist sentenced for supplying drugs on the black market

MHRA investigation reveals illegally supplied opiate painkillers, tranquillisers and medications intended for the treatment of cancer worth £280,490. A registered pharmacist received a 28 months prison sentence at Wolverhampton Crown Court, on 13 January, for illegally supplying Class B and Class C controlled drugs to criminal associates on the black market. The drugs have an [...]

2020-01-15T21:05:11+00:0015.01.2020|Sin categoría|

FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S. [...]

2019-11-12T21:11:48+00:0012.11.2019|Sin categoría|

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019

PRAC starts review of data on skin cancer with Picato EMA’s safety committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure. The review was triggered by data from several studies showing a [...]

2019-09-12T20:13:07+00:0012.09.2019|Sin categoría|

ANSM: Médicaments à base de cyprotérone, à base de méthotrexate, fluoropyrimidines, GILENYA (Fingolimod): retour d’information sur le PRAC de juillet 2019

Lors de la réunion mensuelle du Comité pour l’Evaluation des Risques en matière de Pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA), qui s’est tenue du 8 au 11 juillet 2019 à Amsterdam, le PRAC a démarré une procédure de réévaluation pour les médicaments à base de cyprotérone, finalisé celles concernant les produits à base [...]

2019-08-13T19:58:11+00:0014.08.2019|Sin categoría|

EMA: Consultation on draft guideline on quality requirements for medical devices in combination products

EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation. The guideline addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular the requirements under Article 117. This article foresees that the marketing authorisation application should include a [...]

2019-06-05T21:12:20+00:0005.06.2019|Sin categoría|

ANSM: Recommandations de traitement de l’artériopathie oblitérante des membres inférieurs (AOMI) à l’aide de dispositifs médicaux au paclitaxel

L’ANSM conduit des investigations suite à la méta-analyse récente qui suggère un risque possible de surmortalité, à partir de la deuxième année après implantation, chez les patients atteints d’artériopathie oblitérante des membres inférieurs (AOMI) traités avec des ballons recouverts ou des stents à élution de paclitaxel comparativement à ceux traités avec des dispositifs médicaux sans paclitaxel [...]

2019-05-16T22:27:07+00:0016.05.2019|Sin categoría|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019

EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including two orphan medicines, at its February 2019 meeting. For three of the eight new medicines the CHMP recommended a conditional marketing authorisation. This was the last meeting of the CHMP in London. As of March 2019, all meetings will take place at the new EMA headquarters in Amsterdam. The Committee [...]

2019-03-05T11:00:04+00:0005.03.2019|Sin categoría|

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other [...]

2019-02-12T21:06:42+00:0013.02.2019|Sin categoría|

ANSM: Le sildénafil (Revatio et Viagra et ses génériques) ne doit pas être utilisé pour traiter le retard de croissance intra-utérin

Information destinée aux gynécologues, obstétriciens, pneumologues et cardiologues Un essai clinique du groupe d'études STRIDER, visant à étudier l'effet du sildénafil dans le traitement du retard de croissance intra-utérin (RCIU), a été interrompu prématurément en raison d'un nombre plus important de cas d'hypertension pulmonaire du nouveau-né (HTPN) et d'une augmentation de la mortalité néonatale observés [...]

2018-11-11T12:50:15+00:0012.11.2018|Sin categoría|

(Cas) AEMPS: Información a los laboratorios titulares de medicamentos de uso humano que contienen “mepivacaína”. Decisión de la Comisión C (2018) 5380 final, de fecha 2.08.2018 (Nº EMA: EMEA/H/A-30/1455)

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. La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informa de la publicación en su página web de la Decisión de [...]

2018-09-24T19:10:18+00:0025.09.2018|Sin categoría|

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 [...]

2018-09-24T18:31:11+00:0024.09.2018|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 [...]

2018-06-03T13:16:12+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, [...]

2018-03-13T22:45:39+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 [...]

2018-03-12T23:05:27+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 [...]

2018-02-25T10:47:46+00:0026.02.2018|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 [...]

2017-08-15T22:24:24+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 [...]

2017-04-10T20:54:00+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

2016-12-27T10:50:59+00:0027.12.2016|Sin categoría|