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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. However, the STAND results did not suggest new safety concerns with crizanlizumab. EMA required the STAND study as part of the marketing authorisation.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103
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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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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. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

Ethics 105
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CHMP meeting highlights – July 2022

European Pharmaceutical Review

Under exceptional circumstances Nulibry * (fosdenopterin) was given a positive opinion for the treatment of molybdenum cofactor deficiency type A, an ultra-rare condition that appears shortly after birth and leads to brain injury and death.

Medicine 105
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Nitrosamines: the beginning of the end?

European Pharmaceutical Review

EMA indicates that, “… the less-than lifetime (LTL) concept or the use of interim limits (≤178 ng/day) may be considered by the lead authority and national competent authorities (NCAs) on a temporary basis in order to inform market actions and at the same time ensure availability of medicines”. Org Process Res Dev. 2023; 10.1021.acs.oprd.3c00008.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” This may lead to longer development timelines and higher costs for life science companies. This may also require investments in equipment and facilities.

Safety 75