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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
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MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma.

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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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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.” 30 June 2016.

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NICE backs AZ’s Calquence for new use in leukaemia

pharmaphorum

AstraZeneca’s BTK inhibitor Calquence has become the first targeted oral therapy to be backed by NICE for NHS England patients with chronic lymphocytic leukaemia (CLL) who can’t be treated with first-line chemotherapy. Daiichi Sankyo gets okay for cholesterol drugs.