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European Commission revokes marketing authorisation for Novartis’ crizanlizumab

European Pharmaceutical Review

Crizanlizumab is a once-a-month, humanised monoclonal antibody infusion, indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 years and above. However, the STAND results did not suggest new safety concerns with crizanlizumab.

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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. New hope for stomach cancer patients.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. These changes are summarised in Table 1.

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EU proposes new blood, tissues and cells Regulation

European Pharmaceutical Review

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.

Safety 102
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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. Mansfield also listed the main elements of The Future Clinical Trials Bill.

Ethics 83
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

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CHMP meeting highlights – July 2022

European Pharmaceutical Review

It is not intended for direct use in patients. Tecvayli was supported through EMA’s PRIority MEdicines (PRIME) scheme and its application was reviewed under an accelerated timetable to enable faster patient access to this medicine. COVID-19.