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FDA looks at pulling speedy approvals for three cancer drugs

pharmaphorum

Today (27 April), the ODAC is due to look at Tecentriq in combination with BMS/Celgene’s Abraxane (nab-paclitaxel) for people with advanced triple-negative breast cancer (TNBC) whose tumours express PD-L1, an indication which was provisionally approved by the FDA in 2019 on the strength of the Impassion130 study.

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NICE changes stance on Lilly’s breast cancer dug Verzenio

pharmaphorum

A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast cancer in England and Wales. .

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

Pharmaceutical Technology

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. This announcement is not the only recent development for Keytruda.

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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

1 May 2023 Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI) 1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” Juan Miguel García-Gómez, Ph.D. Chis, Ph.D. 30 June 2016.

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The GoCART Coalition: Guidance for pharmacists

Hospital Pharmacy Europe

11 Many documents and checklists detail every stage of the pathway in preparing CAR T. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. Farm Hosp 2020;44(1):26–31.

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Apixaban vs warfarin: rise of newer anticoagulant

Druggist

In 2019, the first generic version of Eliquis® was approved in the US. Patients who have cancer or receive chemotherapy. More details can be found in a document called Guidance for the safe switching of warfarin to direct oral anticoagulants (DOACs) for patients with non-valvular AF and venous thromboembolism (DVT / PE).

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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.