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Notizie Newsletter

16 Settembre 2019

EMA to provide guidance on avoiding nitrosamines in human medicines

Sep 13, 2019 - EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our ...
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13 Settembre 2019

13 settembre 2019 – Comunicazione EMA sulle impurezze nitrosamminiche

13 Settembre 2019

Statement on improving adverse event reporting of compounded drugs to protect patients

Sep 9, 2019 - Compounded drugs can serve an important medical need for certain patients, however, they also present risks to patients since they are not evaluated by the FDA for safety, effectiveness and quality. The FDA’s compounding program aims to help protect patients ...
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13 Settembre 2019

Congress Must Improve Prior Authorization to Ensure People With Cancer Have Timely Access to Care

Sep 10, 2019 - The American Society of Clinical Oncology (ASCO) joined approximately 350 health care groups in urging members of the U.S. House of Representatives to support the Improving Seniors’ Timely Access to Care Act (H.R. 3107). The bipartisan bill would help ...
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13 Settembre 2019

Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products

Sep 11, 2019 - Today, the Trump Administration announced that as part of its ongoing work to tackle the epidemic of youth e-cigarette use, the FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket ...
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13 Settembre 2019

Safety of pregnancy following breast cancer (BC) in patients (pts) carrying a BRCA mutation (mBRCA): Results of an international cohort study

Very limited data are available on the safety of pregnancy and reproductive outcomes in mBRCA pts with prior BC history. We report the results of the largest study to date addressing these questions. This international, multicenter, hospital-based, retrospective cohort study ...
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12 Settembre 2019

9 settembre 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Durvalumab (AstraZeneca)

12 Settembre 2019

FDA Grants Fast Track Designation to AMG 510 for KRAS G12C+ NSCLC

Sep 9, 2019 - The FDA has granted a fast track designation to the investigational KRAS inhibitor AMG 510 for the treatment of patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) who have received prior treatment. The decision is based on updated phase I data ...
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12 Settembre 2019

FDA Accepts sNDA for Neratinib Combo for HER2+ Breast Cancer

Sep 11, 2019 - The FDA has accepted a supplemental new drug application (sNDA) for neratinib for use in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed at least 2 prior lines of HER2-directed treatments. ...
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12 Settembre 2019

FDA Grants Tepotinib Breakthrough Designation for METex14-Altered NSCLC

Sep 11, 2019 - The FDA has granted a breakthrough therapy designation to the investigational MET inhibitor tepotinib as a treatment for patients with metastatic non–small cell lung cancer (NSCLC) with MET exon14-skipping (METex14) alterations who have progressed on ...
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