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EMA: Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada

EMA is recommending restriction of the use of the multiple sclerosis medicine Lemtrada (alemtuzumab) due to reports of rare but serious side effects, including deaths. New measures to identify and manage the serious side effects are also recommended. The side effects include cardiovascular disorders (affecting the heart, circulation and bleeding as well as stroke) and [...]

2019-11-20T21:45:41+00:0020.11.2019|Pharmacovigilance|

FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. “Today’s approval provides an additional treatment option for patients with [...]

2019-11-19T20:23:22+00:0019.11.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This [...]

2019-11-19T20:18:34+00:0019.11.2019|Drug Development Strategy, Regulatory Affairs|

FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC [...]

2019-11-19T20:12:46+00:0019.11.2019|Pharmacovigilance, Regulatory Affairs|

ANSM: Ceftriaxone (Rocéphine® et génériques) – Rappel sur les voies d’administration

Information destinée aux médecins généralistes, cardiologues, ORL, médecins internistes, pédiatres, gériatres, pneumologues, urologues, néphrologues, gynécologues, gastro-entérologues, chirurgiens, dermatologues, neurologues, orthopédistes, infectiologues, urgentistes, rhumatologues, pharmaciens d’officine, pharmaciens hospitaliers Mise à jour de la lettre envoyée le 22/10/2019 Après échanges avec des professionnels de santé, le message contenu dans la lettre  envoyée le 22 octobre est  mis [...]

2019-11-19T19:59:56+00:0019.11.2019|Pharmacovigilance|

ANSM: Information sur l’actualisation des notices d’Amoxicilline Sandoz et Amoxicilline / Acide Clavulanique Sandoz

Le laboratoire Sandoz a informé l’ANSM d’une importante mise à jour des informations figurant dans les notices des antibiotiques Amoxicilline Sandoz et Amoxicilline/Acide clavulanique Sandoz, afin d’en améliorer le bon usage. Les notices actuellement présentes dans les boites de ces médicaments ne reflètent pas encore cette actualisation. Les notices actualisées sont cependant disponibles sur la base [...]

2019-11-19T19:52:09+00:0019.11.2019|Pharmacovigilance|

Infarmed: Revisão da lista de medicamentos abrangidos pela notificação prévia de exportação ou distribuição para outros Estados-membros

Foi publicada a Deliberação n.º 095/CD/2019, de 11 de novembro, que veio atualizar a lista de medicamentos cuja exportação ou distribuição para outros Estados-membros da União Europeia carece de prévia notificação ao Infarmed. Esta Deliberação entra em vigor no 3.º dia útil seguinte ao da sua publicação, ou seja, no próximo dia 14 de novembro. No [...]

2019-11-17T20:46:37+00:0018.11.2019|Regulatory Affairs|

EMA: Regulators’ advice can make a difference for faster patient access to highly innovative therapies

Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable accelerated access of patients to highly innovative therapies that address unmet medical needs. The chair of EMA’s committee for advanced therapies (CAT), Martina Schussler-Lenz, the chair of EMA’s human medicines committee [...]

2019-11-17T20:38:42+00:0017.11.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Angioedème bradykinique: penser aux inhibiteurs de l’enzyme de conversion (IEC) mais aussi aux antagonistes des récepteurs de l’angiotensine II (sartans) et aux gliptines

Des angioedèmes bradykiniques ont été rapportés chez des patients traités par des inhibiteurs de l’enzyme de conversion (IEC) mais aussi des antagonistes des récepteurs de l’angiotensine II (ARA II) et des gliptines. Ces angioedèmes peuvent avoir des conséquences graves. Aussi, l’ANSM invite les professionnels de santé et les patients à être particulièrement attentifs aux signes [...]

2019-11-17T20:29:37+00:0017.11.2019|Pharmacovigilance|

Infarmed: Revogação da suspensão da autorização de distribuição por grosso de medicamentos de uso humano (Medlog Logistica Farmacêutica, SA)

O Conselho Diretivo deliberou revogar a Deliberação n.º 87/CD/2019 e, deste modo, levantar a suspensão da autorização para o exercício da atividade de distribuição por grosso n.º A020/10/H/002/2017 concedida à sociedade Medlog, Logística Farmacêutica, SA, com instalações sitas na Zona Industrial de Alcochete, distrito de Setúbal, com fundamento no cumprimento do prazo de suspensão aplicado, [...]

2019-11-17T20:15:39+00:0017.11.2019|Regulatory Affairs|

FDA approves first therapy to treat patients with rare blood disorder

Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. “When patients receive multiple blood transfusions, there is a risk for iron overload, which can affect many organs,” said [...]

2019-11-17T20:10:54+00:0017.11.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Xeljanz (tofacitinib), Lemtrada (alemtuzumab), ibuprofène et kétoprofène: retour d’information sur le PRAC de novembre 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 28 au 31 octobre 2019 à Amsterdam, le PRAC a finalisé la réévaluation de Xeljanz (tofacitinib) ainsi que celle concernant Lemtrada (alemtuzumab) et poursuivi la procédure d’évaluation du signal [...]

2019-11-14T21:33:10+00:0014.11.2019|Pharmacovigilance|

Infarmed: Publicado “Regulamento de gestão da disponibilidade do medicamento”

O Regulamento de gestão da disponibilidade do medicamento foi aprovado - através da Deliberação N.º 93/CD/20019 que o anexa - e encontra-se já disponível na área Gestão da disponibilidade do medicamento. Este regulamento tem como objeto a fixação de regras e procedimentos para gerir a disponibilidade do medicamento, designamente no que se refere às notificações de faltas ou [...]

2019-11-14T21:17:31+00:0014.11.2019|Regulatory Affairs|

ANSM: Les flacons de plusieurs produits anti-verrue ne doivent plus être utilisés par les patients et sont à rapporter sur les lieux de vente

En raison du risque de brûlure accidentelle impliquant des dispositifs anti-verrue sous format de flacon de solution monochloroacétique, l’ANSM interdit l’utilisation de deux produits: Expert 1.2.3 Verrues Cutafilm et Steripan Traitement Verrues. Ces produits doivent être rapportés par les patients en pharmacie, parapharmacie  ou grande surface alimentaire (supermarché). Par ailleurs, en raison du risque de [...]

2019-11-13T21:59:14+00:0013.11.2019|Pharmacovigilance|

FDA Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development process, or to learn more about known adverse events. Evaluations occur on more than two [...]

2019-11-13T21:22:57+00:0013.11.2019|Pharmacovigilance, Regulatory Affairs|

Infarmed: Produtos sem finalidade médica com enquadramento regulamentar como dispositivos

O Regulamento (UE) 2017/745 do Parlamento Europeu e do Conselho, de abril de 2017 é aplicável, não só a dispositivos médicos, mas também a produtos para os quais o fabricante alegue unicamente fins estéticos ou outros fins não médicos, mas que sejam muito semelhantes a dispositivos médicos em termos de funcionamento e de perfil de risco. São [...]

2019-11-13T21:18:26+00:0013.11.2019|Regulatory Affairs|

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|

(Cas) AEMPS: Alemtuzumab (Lemtrada): nuevas restricciones de uso

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. Tras finalizar la evaluación europea del balance beneficio-riesgo de alemtuzumab (Lemtrada) se recomienda restringir la indicación terapéutica, ampliar las situaciones en [...]

2019-11-12T21:07:30+00:0012.11.2019|Pharmacovigilance|