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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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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.

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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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NICE axes funding for MSD’s Keytruda in bladder cancer despite appeal

pharmaphorum

Keytruda (pembrolizumab) was being reimbursed on an interim basis for advanced or metastatic urothelial carcinoma, following platinum based chemotherapy, by the Cancer Drugs Fund (CDF) until survival data from a larger study emerged.

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Opdivo backed by NICE for rare gastro-oesophageal cancers

pharmaphorum

In final guidance, NICE has backed Opdivo (nivolumab) as a first-line treatment with chemotherapy for previously untreated HER2-negative advanced gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma tumours that express PD-L1 with a combined positive score (CPS) of 5 or more. . months compared to 11.4