lunedì, 20 marzo 2023

Notizie AIOM – anno XVI n. 666

Regulatory information – adjusted fees for applications to EMA from 1 April 2018

March 5, 2018 - The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2018. Every year, the European CommissionExternal ...
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FDA Panel Backs Blinatumomab for MRD+ ALL

March 7, 2018 - Blinatumomab received an 8 to 4 vote from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in favor of an indication for the treatment of minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL). The FDA will now ...
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Prostate cancer medicine Radium-223 dichloride must not be used with Abiraterone acetate and prednisone/prednisolone

March 9, 2018 - The European Medicines Agency (EMA) has recommended contraindicating the use of the prostate cancer medicine Radium-223 dichloride with Abiraterone acetate and prednisone/prednisolone, due to an increased risk of death and fractures with this combination. ...
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9 marzo 2018 – Comunicazione EMA su Radio-223 dicloruro (Bayer AG)

9 marzo 2018 – Sunset Clause – Warning di prossima decadenza del 9 marzo 2018

9 marzo 2018 – Report di valutazione dell’innovatività

High IDO-1 Expression in Tumor Endothelial Cells is Associated with Response to Immunotherapy in Metastatic Renal Cell Carcinoma

Nivolumab belongs to the standard therapy in the second-line setting of metastatic renal cell carcinoma (mRCC). Although deep and long-lasting responses are seen in some patients, the majority of patients will further progress. PD-L1 as predictive biomarker is still under ...
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FDA Approves 4-Week Nivolumab Dosing Schedule

March 6, 2018 - The FDA has approved a supplemental biologics license application adding a 4-week dosing schedule for nivolumab across several of the PD-1 inhibitor’s indications. Physicians can now prescribe the new dosing schedule of 480 mg of nivolumab infused every ...
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Nut Consumption and Survival in Patients With Stage III Colon Cancer: Results From CALGB 89803 (Alliance)

Observational studies have reported increased colon cancer recurrence and mortality in patients with states of hyperinsulinemia, including type 2 diabetes, obesity, sedentary lifestyle, and high glycemic load diet. Nut intake has been associated with a lower risk of type ...
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FDA Authorizes Direct-to-Consumer Test That Reports Three Mutations in the BRCA1/BRCA2 Breast Cancer Genes

March 6, 2018 - Today, the U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer ...
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