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Notizie AIOM – anno XVII

4 Novembre 2019

FDA Grants RMAT Designation to CAR T-Cell Therapy CT053 for Myeloma

October 31, 2019 - The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to the investigational anti-BCMA CAR T-cell therapy CT053 for the treatment of patients with relapsed/refractory multiple myeloma. The decision was based on results from an ...
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4 Novembre 2019

Avelumab/Axitinib Combo Approved in Europe for Frontline RCC

October 28, 2019 - The European Commission (EC) has approved the combination of avelumab and axitinib for the frontline treatment of adult patients with advanced renal cell carcinoma (RCC), EMD Serono (Merck KGaA) and Pfizer, the codevelopers of avelumab, reported in a press ...
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4 Novembre 2019

Electronic-cigarette smoke induces lung adenocarcinoma and bladder urothelial hyperplasia in mice

Electronic-cigarettes (E-cigs) are marketed as a safe alternative to tobacco to deliver the stimulant nicotine, and their use is gaining in popularity, particularly among the younger population. We recently showed that mice exposed to short-term (12 wk) E-cig smoke (ECS) ...
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4 Novembre 2019

Are we over-treating with checkpoint inhibitors?

Anti-PD-1 antibodies offer potentially life-saving treatment for some cancer patients, but their chronic administration generates high and ever-increasing costs. Despite licensing for long-term use, optimal treatment duration is unknown. We challenge the need for long-term ...
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4 Novembre 2019

31 ottobre 2019 – Aggiornamento sulla carenza del farmaco Mitomicina C (Kyowa Kirin)

4 Novembre 2019

31 ottobre 2019 – Vitamina D – chiarimenti sulla Nota 96

4 Novembre 2019

31 ottobre 2019 – L’evoluzione delle sfide scientifiche e regolatorie globali al centro del summit annuale ICMRA ospitato dall’AIFA

4 Novembre 2019

31 ottobre 2019 – Simposio GCP 2019 – “Dalla ricerca della Qualità alla Qualità della Ricerca”

4 Novembre 2019

SITC Introduces Guidelines for Anti–PD-1 Therapy in HNSCC

October 30, 2019 - Based on strong findings for efficacy and safety, as well as FDA approvals, the Society for Immunotherapy of Cancer (SITC) has issued the first guidelines for the use of immunotherapy agents in patients with recurrent or metastatic (RM) head and neck squamous ...
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4 Novembre 2019

Stephen Hahn, MD, to Be Nominated FDA Commissioner

November 1, 2019 - In a press release issued by the White House today, President Donald J. Trump announced his intention to nominate Stephen Hahn, MD, FASTRO, to be the Commissioner of Food and Drugs at the Department of Health and Human Services. Dr. Hahn has been Chief ...
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