Notizie AIOM – anno XVI n. 692

2 Ottobre 2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

September 28, 2018 - Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure ...
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2 Ottobre 2018

FDA Approves Cemiplimab for CSCC

September 28, 2018 - The FDA has approved the PD-1 inhibitor cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation. The approval ...
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2 Ottobre 2018

Harnessing the potential of real world data through a ‘learning healthcare system’

September 27, 2018 - Real world data (RWD) hold the promise to substantially increase the effectiveness and efficiency of all processes in the development and utilisation of medicines, from research and development, to regulatory decision-making, pricing and reimbursement ...
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2 Ottobre 2018

Incidence of secondary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with ovarian or breast cancer in a real-world setting in the United States

Real-world data on patients with cancer developing secondary malignancies such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) are lacking. This study assessed the incidence and impact of select DNA-damaging therapy exposure on risk of secondary MDS and ...
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2 Ottobre 2018

28 settembre 2018 – Aggiornamento: Sunset Clause – Elenco delle AIC decadute per mancata commercializzazione

2 Ottobre 2018

28 settembre 2018 – Divieto di utilizzo lotti medicinali plasmaderivati della ditta Kedrion

2 Ottobre 2018

28 settembre 2018 – Comunicazione EMA su valsartan

2 Ottobre 2018

Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018

September 28, 2018 - The European Medicines Agency (EMA) would like to inform applicants and marketing authorisation holders that adjusted fees for pharmacovigilance applications are expected to come into effect as of 18 October 2018. The European Commission has adopted ...
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28 Settembre 2018

26 settembre 2018 – Chiusura Registro di monitoraggio Regorafenib (Bayer) (CRC)

28 Settembre 2018

ASCO Praises Congress for Continuing to Invest in Federal Research

September 27, 2018 - ASCO applauds Congress for passing a $2 billion increase in funding for the National Institutes of Health (NIH), which will bring NIH's budget to a total of $39.1 billion and the National Cancer Institute's to a total of $6.147 billion. We are grateful ...
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LAVORIAMO CON

News

I GRUPPI DI MELISI E RENI VINCITORI DEL BANDO DI RICERCA PROMOSSO DA FONDAZIONE UMBERTO VERONESI ETS E FICOG SUL TUMORE AL PANCREAS

TUMORE DEL SENO, IN 5 ANNI PRESCRITTI IN ITALIA 30MILA TEST GENOMICI. GLI ESPERTI: “ESAMI SEMPRE PIU’ EFFICACI PER PERSONALIZZARE LE TERAPIE”

TUMORI: “LA DECISIONE DEL MOLECULAR TUMOR BOARD MIGLIORA IL TEMPO DI CONTROLLO DELLA MALATTIA. OGNI ANNO IN ITALIA 15.000 PAZIENTI CANDIDATI A PROFILAZIONE GENOMICA ESTESA”

BRISTOL MYERS SQUIBB: “AL VIA LA STAFFETTA CICLISTICA PER RACCOGLIERE FONDI. SOSTENIAMO IL PERCORSO DI ASCOLTO PER PAZIENTI CON TUMORI TORACICI RARI”

CANCRO DEL SENO, CON LA MALATTIA -35% DI PROBABILITA’ DI GRAVIDANZA. IL GIM: “LA RICERCA CLINICA SIA “SU MISURA” DELLE GIOVANI PAZIENTI”

BEONE: PAOLA COCO NOMINATA MEDICAL AFFAIRS DIRECTOR ITALY

IPERTENSIONE ARTERIOSA NON CONTROLLATA O RESISTENTE AL TRATTAMENTO, BAXDROSTAT CONFERMA LA SUA EFFICACIA A 52 SETTIMANE. “PERSISTENZA DEL BENEFICIO PRESSORIO A LUNGO TERMINE CONSOLIDA LA RILEVANZA DEL RUOLO DELL’ALDOSTERONE E APRE A NUOVE PROSPETTIVE TERAPEUTICHE”

Notizie AIOM – anno XVI n. 692

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA Approves Cemiplimab for CSCC

Harnessing the potential of real world data through a ‘learning healthcare system’

Incidence of secondary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with ovarian or breast cancer in a real-world setting in the United States

28 settembre 2018 – Aggiornamento: Sunset Clause – Elenco delle AIC decadute per mancata commercializzazione

28 settembre 2018 – Divieto di utilizzo lotti medicinali plasmaderivati della ditta Kedrion

28 settembre 2018 – Comunicazione EMA su valsartan

Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018

26 settembre 2018 – Chiusura Registro di monitoraggio Regorafenib (Bayer) (CRC)

ASCO Praises Congress for Continuing to Invest in Federal Research