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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.

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FDA won’t back Lilly’s PD-1 antibody based on Chinese data alone

pharmaphorum

In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US.

FDA 52
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Scotland backs three new uses for MSD’s Keytruda

pharmaphorum

The Scottish Medicines Consortium (SMC) gave the go-ahead to the regimen based on data from the KEYNOTE-775 study , which showed that the duo can increase survival time for patients and may improve quality of life by reducing the symptom burden compared to standard chemotherapy.

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How my experience as a patient helped shape NICE guidelines for colorectal cancer

NICE

Contributing my personal experience to the discussion, I shared my experience of developing chronic peripheral neuropathy, which came about as a side effect following chemotherapy. about managing and monitoring symptoms and reducing dosage of chemotherapy if necessary will also help. So, what’s next for me?

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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.” link] 7 He, J.,

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The GoCART Coalition: Guidance for pharmacists

Hospital Pharmacy Europe

8 The GoCART Coalition In 2020, the European Society of Blood and Marrow Transplantation and the European Hematology Association joined forces and launched GoCART – a multi-stakeholder coalition in the field of gene and cellular therapies manufactured from cells and tissues of haematopoietic origin.

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Apixaban vs warfarin: rise of newer anticoagulant

Druggist

Examples of patients who should not be changed from warfarin to apixaban or other newer anticoagulant (Williams, 2020): Patients with prosthetic mechanical valve. Patients who have cancer or receive chemotherapy. Pregnant or breastfeeding women. Patients who have an IRN target outside the standard range (2.0-3.0).