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Notizie Newsletter

28 Ottobre 2019

Gilteritinib Approved in Europe for Relapsed/Refractory FLT3+ AML

October 25, 2019 - The European Commission has approved gilteritinib as a single agent for the treatment of relapsed/refractory patients with FLT3-mutant acute myeloid leukemia (AML). The approval is based on findings from the phase III ADMIRAL trial, which showed that the ...
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25 Ottobre 2019

22 ottobre 2019 – Registri AIFA: informazioni sui dati dei trattamenti con i nuovi farmaci per la cura dell’epatite C

25 Ottobre 2019

23 ottobre 2019 – Comitato per i Medicinali per Uso umano (CHMP) dell’EMA: highlights del meeting di ottobre

25 Ottobre 2019

FDA grants first-ever modified risk orders to eight smokeless tobacco products

October 22, 2019 - The U.S. Food and Drug Administration announced today that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless ...
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22 Ottobre 2019

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019

October 18, 2019 - EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2019 meeting. The Committee recommended granting a conditional marketing authorisation for Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live), the first ...
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22 Ottobre 2019

Daratumumab Triplet Nears EU Approval for Frontline Transplant-Ineligible Myeloma

October 18, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed approval of daratumumab for use in combination with lenalidomide and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma ...
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22 Ottobre 2019

EU Panel Backs Pembrolizumab Regimens for Frontline HNSCC

October 18, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of pembrolizumab as a monotherapy or in combination with platinum and 5-FU as frontline treatment for patients with metastatic or unresectable ...
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21 Ottobre 2019

FDA Grants Trastuzumab Deruxtecan Priority Review for HER2+ Breast Cancer

October 17, 2019 - The FDA has granted a priority review designation to a biologics license application (BLA) for trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer. The BLA is supported by data from a phase I trial2 ...
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21 Ottobre 2019

European countries increase commitment to responsible antibiotic use in animals

October 15, 2019 - A report published by EMA shows that European countries continue to reduce the use of antibiotics in animals. The overall sales of veterinary antibiotics across Europe dropped by more than 32% between 2011 and 2017. In particular, two of the critically ...
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21 Ottobre 2019

Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial

Dual blockade of the EGFR and VEGF pathways in EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) is supported by preclinical and clinical data, yet the approach is not widely implemented. RELAY assessed erlotinib, an EGFR tyrosine kinase inhibitor (TKI) standard ...
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