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STAT+: FDA will allow troubled chemotherapy maker to resume distribution of cancer drugs in short supply

STAT

After finding a “cascade of failures” at a manufacturing plant run by a key chemotherapy supplier, the Food and Drug Administration will not allow the company to resume distribution in the U.S. beyond some   cancer medicines that are in short supply.

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STAT+: Intas Pharma employee used acid to destroy manufacturing records at troubled plant

STAT

Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility.

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NICE recommends interim funding for GSK’s Zejula in ovarian cancer

pharmaphorum

GSK estimates that around 3,000 people could benefit annually from the decision covering advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, who have completed and shown a response to platinum-based chemotherapy. Zejula pills are taken three times daily.

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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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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.

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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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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.