giovedì, 12 settembre 2024

Notizie AIOM – anno XVII n. 740

Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Niraparib, an inhibitor of poly(adenosine diphosphate -ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence ...
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Four-week limit for use of high-strength estradiol creams

Oct 4, 2019 - EMA’s safety committee (PRAC) has recommended limiting the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4 weeks. This measure is intended to minimise the risk of side effects caused ...
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EMA Management Board: highlights of October 2019 meeting

Oct 4, 2019 - At its 3 October 2019 meeting in Amsterdam, the European Medicines Agency's Management Board elected Lorraine Nolan as vice-chair of the Board for a three-year period. Dr Nolan is Chief Executive of the Health Products Regulatory Agency (HPRA) in Ireland, a ...
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4 ottobre 2019 – Biosimilari: l’ICMRA ne ribadisce vantaggi e benefici per pazienti e sistemi sanitari a livello globale

The Drug Rediscovery protocol facilitates the expanded use of existing anticancer drugs

The large-scale genetic profiling of tumours can identify potentially actionable molecular variants for which approved anticancer drugs are available. However, when patients with such variants are treated with drugs outside of their approved label, successes and failures ...
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4 ottobre 2019 – Abrogazione del decreto 12/12/2003 “Nuovo modello di segnalazione di reazione avversa a farmaci e vaccini”

4 ottobre 2019 – Comunicazione EMA sull’uso di creme ad alto dosaggio di estradiolo

New ASCO System Confronts Lack of EHR Interoperability

Oct 3, 2019 - With the recent launch of a free, open-source system for standardizing the electronic storage of patient records, the American Society of Clinical Oncology (ASCO) hopes to improve information flow across electronic health record (EHR) platforms and curtail ...
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FDA Updates Neratinib Label in HER2+ Breast Cancer

Oct 3, 2019 - The FDA has approved a labeling supplement for neratinib for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer. The labeling supplement includes safety information based on interim results of the phase II CONTROL trial ...
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FDA Grants Niraparib Breakthrough Designation for BRCA+ mCRPC

Oct 3, 2019 - The FDA has granted a breakthrough therapy designation to the PARP inhibitor niraparib for the treatment of patients with BRCA1/2–mutant metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and ...
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