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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. Brussels; 2020. EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2022.

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Roivant joins RNA splicing push with Eisai deal

pharmaphorum

The compound, called H3B-8800, is currently in phase 1 testing in the US and Europe in patients with myelodysplastic syndrome (MDS) who carry mutations in splicing factor 3B subunit 1 (SF3B1) by Eisai’s H3 Biomedicine subsidiary.

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How to approach die plate adhesion during tableting

European Pharmaceutical Review

In most cases, formulation compounds represent a fixed starting point from which any changes can be implemented, whereas tableting process parameters as well as machine condition, can be managed and optimised to their best, combining the knowledge of the machine manufacturer with the experience of the pharmaceutical industry.

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

European Pharmaceutical Review

11 The THR pathway was created with the purpose of establishing a simplified registration procedure for all traditional herbal medicines that do not fulfil the requirements for the MA (strict) pathway under Directive 2001/83/EC. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation. 2012/1916).

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Three strategies for managing loss of exclusivity successfully

pharmaphorum

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. AstraZeneca’s patent for its top-selling gastroesophageal reflux disease drug was due to expire in 2001. Simultaneous with the switch to NEXIUM, AstraZeneca grew its overall Gastroenterology franchise – by nearly 9% from 2001 to 2002.

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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active.

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Molecular Farming: Paving a Modern Track for Pharmaceutical Sectors (Molecular Pharming)

PharmaShots

Since time immemorial, plants have been widely used as a source of medicinal compounds. These guidelines are largely specified by the European Commission (EC) in Directive 2001/83/EC and Regulation (EC) No 726/2004.