Issue: Vol. 41

Pirtobrutinib

Pirtobrutinib (Jaypirca) is a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor developed by Eli

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How to transition to e-labelling – practical first steps

E-labelling provides patients and healthcare professionals with up-to-date product and safety information. Schlafender Hase’s Dr. Jutta M. Hohenhörst discusses the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies across today’s labelling landscape, and add value for patients.

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Next-generation approaches to statistical significance

Biopharma Excellence recently hosted a panel discussion featuring experts in biotech and the evolving regulatory environment to discuss the challenge of achieving statistical significance with novel and highly targeted therapies.

Daniel O’Connor of the UK’s MHRA, with a remit of Innovation Acceleration within a regulatory context, noted that the challenge of achieving statistical significance when target populations are tiny is nothing new, but conceded that randomised trials aren’t always viable – especially with very rare conditions. He urged drug developers to seek scientific advice before finding workarounds.

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Sustainability – What Does it Mean for Excipient Makers and Users

IPEC, an industry association of manufacturers, distributors and users of excipients is about to publish an updated draft version of its Excipient Information Package – User Guide and Templates. This new version will include a new part to facilitate and standardise the exchange of Sustainability information covering the very broad range of aspects dealing with Corporate Social Responsibility and Environment, Social and Governance.
This article provides a heads-up and a call out for your feedback when a draft version is ready for review.

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Bexagliflozin

Bexagliflozin (EGT1442), sold under the brand name Brenzavvy by TheracosBio, is an antidiabetic medication used to improve

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