Notizie AIOM – anno XVII
Former FDA Commissioner Scott Gottlieb Forecasts Future of Biosimilars
October 27, 2019 - There are several impediments in bringing biosimilars to market, including a general lack of education, according to former FDA commissioner Scott Gottlieb, MD. “If you look at the early days of the Hatch-Waxman Act, there was a lot of physician ...Leggi tutto
Dialogue with Chinese authorities on medicine regulation
October 25, 2019 - The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation. The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals. ...Leggi tutto
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 ...Leggi tutto
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 ...Leggi tutto
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 ...Leggi tutto
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 ...Leggi tutto