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Mashup Score: 4
European Medicines Agency, Amsterdam, the Netherlands The European Medicines Agency (EMA) and the European Organisation for Research and Treatment of Cancer (EORTC) are co-chairing the Cancer Medicines Forum (CMF) which objective is to integrate the work of the academic sector into the regulatory decision-making process by acting as an unique channel between the regulator and academic clinical research. The deliverables of the CMF are aimed at supporting policy decisions to facilitate treatment optimisatio
Source: www.ema.europa.euCategories: General Medicine News, Onc News and JournalsTweet
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Mashup Score: 8Cibinqo - opinion on variation to marketing authorisation | European Medicines Agency - 3 month(s) ago
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicin al product Cibinqo. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG. The CHMP adopted an extension to the existing indication to include treatment of adolescents aged 12 years and older. For information, the full indication will therefore be as follows 1: Cibinqo is indicated for
Source: www.ema.europa.euCategories: General Medicine News, Allergy-ImmunologyTweet
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Mashup Score: 26Casgevy | European Medicines Agency - 5 month(s) ago
On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional 1 marketing authorisation for the medicinal product Casgevy 2, intended for the treatment of transfusion‑dependent β‑thalassemia (TDT) and sickle cell disease (SCD). As Casgevy is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. The applicant for this medicinal product is
Source: www.ema.europa.euCategories: General Medicine News, Hematologists1Tweet-
🔴El comité técnico (CHMP)de la EMA recomienda la autorización de la #TerapiaGénica basada en #CRISPR exa-cel (#Casgevy)en #drepanocitosis y beta #talasemia dependiente de transfusiones (#TDT),para pacientes >11 años sin donante emparentado HLA compatible https://t.co/X3II7zBb9y https://t.co/AlgR2kpAjM
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Mashup Score: 1Executive Director - European Medicines Agency - 5 month(s) ago
Executive Director
Source: www.ema.europa.euCategories: General Medicine News, Infectious DiseaseTweet
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Mashup Score: 142Talzenna: Pending EC decision - European Medicines Agency - 6 month(s) ago
Talzenna: Pending EC decision
Source: www.ema.europa.euCategories: General Medicine News, Hem/OncsTweet-
On November 9, 2023, European Medical Agency (EMA) approved Talazoparib + Enzalutamide combination for pts with mCRPC #prostatecancer based on results of Talapro-2 ph3 trial.👇Weblink 👉 https://t.co/XaH5a9PWbb @OncoAlert @PCFnews @urotoday @APCCC_Lugano @huntsmancancer https://t.co/lbIbsz6hWC https://t.co/MJBfi8ermw
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Mashup Score: 2Use of real-world evidence in regulatory decision making – EMA publishes review its studies - European Medicines Agency - 7 month(s) ago
Use of real-world evidence in regulatory decision making – EMA publishes review its studies
Source: www.ema.europa.euCategories: General Medicine News, Hem/OncsTweet
We are excited to be at the @EMA_News in Amsterdam for the #CancerMedicinesForum hybrid workshop! 🎥https://t.co/c8GztC9WP1 The CMF is reporting its observations and preliminary solutions to address #TreatmentOptimisation and discussing the proposed way forward. @EU2024BE https://t.co/qCaePFgdbw