Role of Big Data for Evaluation and Supervision of Medicines in the EU
Summary report of the Heads of Medicines Agencies – EMA Joint Big Data task force
Oncology News
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Two Health Consortia to Develop a Detailed Feasibility Proposal for Europe’s Next €1-billion Science Projects
LifeTime and RESTORE among shortlisted projects
NICE Develops a Medtech Innovation Briefing on Axumin
Axumin is a radiopharmaceutical agentfor functional imaging of prostate cancer recurrence
Gustave Roussy and Institut Bergonié, Partners for Early Phase Trials and Therapeutic Innovation in Oncology
Increase in accrual capacity and the quality standards
Withdrawal of the EU Marketing Authorisation Applications for Cavoley and Efgratin
Both contain the active substance pegfilgrastim and were developed as a biosimilar medicine
FDA Approved Caplacizumab-yhdp
Approval is based on results from the HERCULES trial
Companies That Make Sartan Medicines Should Review Their Manufacturing Processes to Avoid Presence of Nitrosamine Impurities
Recommendations follow EMA’s review of substances classified as probable human carcinogens
EMA Adopts a New Indication for Pembrolizumab
It is indicated in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of metastatic squamous NSCLC
EMA Recommends an Extension to One of the Existing Indications for Atezolizumab
It is indicated in combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC
EMA Recommends Granting a Marketing Authorisation for Dacomitinib
It is indicated as monotherapy in the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR activating mutations
Lung Carcinoma In Situ Features Profiled
Genomic, epigenomic, and transcriptomic changes described in pre-invasive lesions
NICE Issues Recommendations for Axicabtagene Ciloleucel for Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal Large B-Cell Lymphoma
More evidence on axicabtagene ciloleucel is being collected