Notizie AIOM – anno XVII n. 712
Change of time zone due to EMA’s relocation in March 2019
March 1, 2019 - EMA leaves its London premises on 1 March 2019 and relocate to Amsterdam, the Netherlands. During EMA's period of reduced virtual presence from 4 March to 8 March inclusive, EMA's working hours will continue to follow Greenwich Mean Time (GMT). From 11 March ...Leggi tutto
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019
March 1, 2019 - EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including two orphan medicines1, at its February 2019 meeting. For three of the eight new medicines the CHMP recommended a conditional marketing authorisation. This was ...Leggi tutto
Regulatory information – adjusted fees for applications to EMA from 1 April 2019
March 1, 2019 - 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 2019. Every year, the European Commission adopts ...Leggi tutto
New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
March 1, 2019 - EMA’s human medicines committee (CHMP) has adopted a positive opinion for sotagliflozin intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus. Sotagliflozin is a small molecule with dual inhibitor activity on SGLT1 and ...Leggi tutto
EU Panel Backs Lorlatinib for ALK+ NSCLC
March 1, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of lorlatinib for the treatment of adult patients with ALK-positive advanced non–small cell lung cancer (NSCLC) whose disease has progressed ...Leggi tutto
EU Panel Backs Olaparib for BRCA-Mutant Advanced Breast Cancer
March 1, 2019 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to olaparib tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic ...Leggi tutto
FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer
February 25, 2019 - The U.S. Food and Drug Administration has issued a warning letter to Total Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole ...Leggi tutto
FDA Grants Lenalidomide/Rituximab Priority Review for Indolent Non-Hodgkin Lymphoma
February 26, 2019 - The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the R2 regimen of lenalidomide plus rituximab for use in patients with previously treated follicular lymphoma and marginal zone lymphoma (MZL). The sNDA ...Leggi tutto
FDA Panel Votes Against Accelerated Approval of Selinexor for Myeloma
February 26, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 against accelerated approval of a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma, recommending delaying a decision on ...Leggi tutto