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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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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. Directive 2011/62/EU of the European Parliament and of the Council.” Published 2011.

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A history of blood cancer treatment

pharmaphorum

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 1942 – Chemotherapy moves from trenches to treatment . Before the birth of bone marrow transplants, patients were often treated using chemotherapy, which could be used to kill cancer cells.

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Apixaban vs warfarin: rise of newer anticoagulant

Druggist

2011): Apixaban was superior ( better ) to warfarin in preventing stroke/ clots formation in patients with atrial fibrillation. Patients who have cancer or receive chemotherapy. This trial also looked at rates of major bleeds and deaths from any reasons during the trial. Main results from the trial (Granger et al.,