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FDA looks at pulling speedy approvals for three cancer drugs

pharmaphorum

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

FDA 90
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The GoCART Coalition: Guidance for pharmacists

Hospital Pharmacy Europe

1,2 CAR T-cell products, such as tisagenlecleucel and axicabtagene ciloleucel, have been available on the European market for clinical use since 2018 3-5 and are used to treat patients who have not responded to other first-line therapies. 11 Many documents and checklists detail every stage of the pathway in preparing CAR T.

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NICE axes funding for MSD’s Keytruda in bladder cancer despite appeal

pharmaphorum

Keytruda (pembrolizumab) was being reimbursed on an interim basis for advanced or metastatic urothelial carcinoma, following platinum based chemotherapy, by the Cancer Drugs Fund (CDF) until survival data from a larger study emerged.

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The changing treatment landscape of acute lymphoblastic leukaemia

Hospital Pharmacy Europe

These patients often reach the ceiling for toxicity in terms of chemotherapy and radiotherapy in the context of a bone marrow transplant. It’s a good way forward – much easier than delivering chemotherapy or transplant given the long-term side effects of these treatments. We’re investigating ways to do that and are collecting data.

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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” 10 April 2018.