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European Commission revokes marketing authorisation for Novartis’ crizanlizumab

European Pharmaceutical Review

Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA).

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EMA revises guidance on nitrosamine impurities

European Pharmaceutical Review

The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products offers guidance and recommendations on mitigation and prevention of nitrosamine-contaminated human medicinal products.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Nitrosamine drug substance-related impurities (NDSRIs)

European Pharmaceutical Review

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.

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API nitrosamines: method sensitivity issues

European Pharmaceutical Review

For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published. This data provides invaluable insight into the likelihood of nitrites in a drug product formulation. Procedure under Article 5(3) of Regulation EC (No) 726/2004. 2022 [cited 30 July 2022].

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The future of targeted alpha therapy development and manufacture

European Pharmaceutical Review

Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024. Orano Med is now building industrial facilities throughout the world for the commercialisation its drugs.

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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.