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L’ANSM modifie les conditions de prescription et délivrance de la prophylaxie pré-exposition (PrEP) au VIH

Comme annoncé par le ministre chargé de la santé le 28 mai 2021, l’accès à la prophylaxie pré-exposition au VIH a été simplifié avec la possibilité d’une initiation par tout médecin. Jusque-là, seuls les médecins exerçant à l’hôpital ou dans un centre gratuit d'information, de dépistage et de diagnostic (CeGIDD) pouvaient la prescrire. Ceci est effectif [...]

2021-06-09T21:29:27+00:0009.06.2021|Sin categoría|

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant [...]

2021-05-26T09:00:56+00:0026.05.2021|Sin categoría|

FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal). The Tiger Tech COVID Plus Monitor is [...]

2021-03-23T20:48:01+00:0023.03.2021|Sin categoría|

(Cas) AEMPS: La EMA publica la versión 2 de la guía de Implementación EU IDMP 2.0

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 AEMPS junto con otras agencias nacionales, la EMA y la industria farmacéutica, están trabajando para la implementación de los estándares [...]

2021-03-08T20:00:08+00:0008.03.2021|Sin categoría|

ANSM: PRODILANTIN 75 mg/ml (fosphénytoïne sodique), équivalent à 50 mg/ml de phénytoïne sodique (EP): nouvelle diffusion des guides posologiques (adulte et enfant) afin d’éviter l’utilisation chez les enfants de moins de 5 ans et les erreurs médicamenteuses

Information destinée aux services d’urgence, SAMU/SMUR, de réanimation/soins intensifs, de neurologie et de neurochirurgie, de pédiatrie, et aux pharmaciens hospitaliers Les guides posologiques de la spécialité PRODILANTIN 75 mg/ml sont de nouveau envoyés aux professionnels de santé afin notamment de détailler les modalités pour l’administration de doses de charge chez l’enfant de plus de 5 [...]

2021-02-04T19:47:02+00:0004.02.2021|Sin categoría|

(Cas) AEMPS: Instrucciones para la industria farmacéutica relativas a materiales sobre prevención de riesgos de medicamentos de uso humano

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 AEMPS informa de que ya está vigente la instrucción nº1/2020 de la Agencia Española de Medicamentos y Productos Sanitarios, relativa a [...]

2020-12-17T19:27:16+00:0017.12.2020|Sin categoría|

FDA Authorizes Drug Combination for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial [...]

2020-11-26T18:36:03+00:0026.11.2020|Sin categoría|

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.). The CHMP’s decision to start the rolling review of mRNA-1273 is based on preliminary results from non-clinical studies and early clinical studies in adults [...]

2020-11-24T19:40:45+00:0024.11.2020|Sin categoría|

EMA: New gene therapy to treat rare genetic disorder metachromatic leukodystrophy

EMA has recommended granting a marketing authorisation in the European Union for the gene therapy Libmeldy to treat metachromatic leukodystrophy (MLD), a rare inherited metabolic disease that affects the nervous system. Libmeldy is indicated for use in children with the ‘late infantile’ or ‘early juvenile’ forms of MLD, who have been identified as carriers of the defective [...]

2020-10-21T22:29:09+00:0021.10.2020|Sin categoría|

EMA: Highlights of Management Board: October 2020 meeting

The October 2020 meeting of the Management Board focused in particular on the Agency’s activities in response to the COVID-19 pandemic. The meeting was Guido Rasi’s final Board meeting as EMA’s Executive Director before Emer Cooke takes the helm in mid-November. Update on COVID-19 activities The Management Board was updated that the first ‘rolling review’ of data [...]

2020-10-07T20:52:33+00:0007.10.2020|Sin categoría|

EMA: First antibody-drug conjugate for multiple myeloma patients with limited treatment options

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Blenrep (belantamab mafodotin) to treat adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. Multiple myeloma is a cancer of a type of [...]

2020-07-30T21:26:49+00:0030.07.2020|Sin categoría|

ANSM: Lénograstim (GRANOCYTE) – ajout de mises en garde sur le risque d’accident thromboembolique artériel et veineux: retour d’information sur le PRAC de juin 2020

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 08 au 11 juin 2020, le PRAC a ajouté des mises en garde sur le risque d’accident thromboembolique artériel et veineux avec Lénograstim (GRANOCYTE). Le lénograstim (rHuG-CSF ; GRANOCYTE) est un facteur [...]

2020-07-29T20:40:51+00:0029.07.2020|Sin categoría|

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under [...]

2020-07-20T20:20:26+00:0020.07.2020|Sin categoría|

FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord

The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves [...]

2020-06-16T21:45:24+00:0016.06.2020|Sin categoría|

Infarmed: Novas medidas para evitar erros de administração de medicamentos contendo leuprorrelina

A Agência Europeia do Medicamento (EMA na sigla inglesa) e o Infarmed recomendam novas medidas para administração de medicamentos contendo leuprorrelina de libertação prolongada (formulação depot) para evitar erros de manuseamento que podem resultar em subdosagem e falta de eficácia. Os medicamentos contendo leuprorrelina (administrados por via subcutânea ou intramuscular de libertação contínua prolongada) são utilizados no [...]

2020-05-28T20:41:20+00:0028.05.2020|Sin categoría|

ANSM: Traitement de l’artériopathie oblitérante des membres inférieurs (AOMI): l’utilisation de ballons ou de stents au paclitaxel doit toujours être réservée aux patients les plus sévères

A l’issue d’une réunion d’échange ayant réuni le 3 mars des représentants de patients, des professionnels de santé du domaine ainsi que les autorités de santé, l’ANSM maintient ses recommandations de mai 2019 d’utiliser préférentiellement les options thérapeutiques alternatives aux ballons et aux stents au paclitaxel pour traiter les patients atteints d’artériopathie oblitérante des membres [...]

2020-05-22T17:39:48+00:0022.05.2020|Sin categoría|

FDA Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions

The U.S. Food and Drug Administration today granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds). Continuous hemodialysis or hemofiltration therapy – known as continuous renal replacement therapy (CRRT) – involves using a [...]

2020-05-06T19:34:06+00:0006.05.2020|Sin categoría|

Infarmed: Orientações relativas ao circuito e pedidos de importação-exportação de medicamentos contendo substâncias controladas, no atual contexto de pandemia COVID-19

No âmbito das medidas que estão a ser desencadeadas para fazer face à pandemia da doença COVID-19, bem como das orientações já emanadas por esta Autoridade, e de modo a assegurar o acesso dos medicamentos a todos utentes e agilização das atividades desenvolvidas pelas diversas entidades do circuito do medicamento, informa-se que excecionalmente poderão ser [...]

2020-04-06T10:50:05+00:0006.04.2020|Sin categoría|