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Roche’s Tecentriq loses bladder cancer use as FDA crackdown continues

pharmaphorum

Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their early promise. The Swiss pharma said it is voluntarily withdrawing the US indication for the immunotherapy Tecentriq (atezolizumab) in metastatic urothelial carcinoma (mUC) previously treated with chemotherapy.

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FDA looks at pulling speedy approvals for three cancer drugs

pharmaphorum

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . 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.

FDA 89
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BMS sets up Roche, Pfizer rivalry with Turning Point takeover

pharmaphorum

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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Amoxicillin-potassium clavulanate interactions to avoid

The Checkup by Singlecare

Sources Analysis of reports of unintended pregnancies associated with the combined use of non-enzyme-inducing antibiotics and hormonal contraceptives , British Medical Journal (2020) Oral contraceptive efficacy and antibiotic interaction: a myth debunked , Journal of the American Academy of Dermatology (2002) Treatment of pneumococcal meningitis with (..)

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Nicolas Paquette-Lamontagne, VP, Medical Affairs at Blueprint Medicines Shares his Views on Clinical Data of Ayvakit for Patients with Systemic Mastocytosis

PharmaShots

Traditional therapies have included multi-kinase inhibitors, chemotherapy, and symptom-directed treatments. There is a need for new therapies that selectively target the underlying mutation, KIT D816V, to improve outcomes and quality of life for people living with SM.

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Nicolas Paquette-Lamontagne, VP, Medical Affairs at Blueprint Medicines Shares his Views on Clinical Data of Ayvakit for Patients with Systemic Mastocytosis

PharmaShots

Traditional therapies have included multi-kinase inhibitors, chemotherapy, and symptom-directed treatments. There is a need for new therapies that selectively target the underlying mutation, KIT D816V, to improve outcomes and quality of life for people living with SM.

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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

30 June 2016. Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” 3 (2016): 76–8. SPuMoNI is particularly timely because blockchain has been proposed to become “a new digital service infrastructure” for Europe. link] 6 BBC News. Published 19 January 2017. link] 7 He, J., Cai, and X. 10 April 2018.