Tag: EMA

Novartis Receives Positive CHMP Opinion for Tabrecta for Patients with METex14 Advanced NSCLC
April 22, 2022 Off

Novartis Receives Positive CHMP Opinion for Tabrecta for Patients with METex14 Advanced NSCLC

By Author

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Novartis’s Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

EMA and the EUnetHTA 21 consortium set priorities for their collaboration
April 13, 2022 Off

EMA and the EUnetHTA 21 consortium set priorities for their collaboration

By Author

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a  joint work plan until 2023. The focus of the plan is to prepare, from a methodological and operational perspective, for the coming into application of the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025 after a 3-year implementation period.

ECDC and EMA: No Need for the Second Booster
April 7, 2022 Off

ECDC and EMA: No Need for the Second Booster

By Author

The European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF) have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines (Pfizer’s Comirnaty and Moderna’s Spikevax) in the general population.

EMA recommends approval for use of Kineret in COVID-19 to the European Commission
December 17, 2021 Off

EMA recommends approval for use of Kineret in COVID-19 to the European Commission

By Dino Mustafić

EMA’s human medicines committee (CHMP) has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.

EMA validates Hutchmed’s Surufatinib
July 16, 2021 Off

EMA validates Hutchmed’s Surufatinib

By Dino Mustafić

The European Medicines Agency (EMA) has validated and accepted Chinese HUTCHMED Limited’s marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).