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CHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
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Technology
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NICE recommends gene therapy for severe sickle cell disease
The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.
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UK enhances ILAP to accelerate access to innovative medicines
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
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Enhancing spectroscopy analysis with machine learning
The spectroscopy-based study highlights the importance of integrating data-driven approaches to enhance isomer discrimination.
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UK biotech on “positive trajectory”, says BIA
Cutting-edge science and large international investment are driving growth in the UK’s biotech sector, the organisation’s new report reveals.
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Considerations for a successful tech transfer of a biologics upstream process
Bioprocess experts from Lonza discuss how molecular format and the product lifecycle phase impact the process, risks and outcomes of upstream technology transfer of biologics.
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AstraZeneca Canadian investment to drive R&D growth
The US$570m investment will contribute to advancing AstraZeneca’s global clinical pipeline, a key goal of its strategy to 2030.
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Sustainability and technology advancement driving spectroscopy market
Integration of industry 4.0 is anticipated to steer growth of the process spectroscopy market into the next decade, a report predicts.
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New guidance to aid cost-effectiveness analysis of new drugs
The report aims to support development of economic models for health technology assessment (HTA) decision making, as there has been “little change in guidance on the use of surrogate endpoints in HTA since 2018”.
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Long-term potential revealed for novel modifier gene therapy
The positive two-year findings from the Phase I/II gene therapy trial in retinitis pigmentosa reiterate the potential of mutation-agnostic therapies.
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Embracing green innovation in life sciences
Shishir Patel, Medical Director at Chiesi UK and Ireland, explores the efforts made to develop sustainable healthcare solutions in life sciences. Alongside examining low global warming potential (GWP) propellants and the need for investment in sustainable R&D infrastructures, he highlights the urgency for action on climate change and the importance…
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Potential blockbuster drugs to watch in 2025
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
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Hydrogel encapsulation: unlocking the potential of cell therapies for targeted treatments
In this article, Dr Stephen Harrington, Director of Cell and Hydrogel Formulation and Francis Karanu, Vice President of Cell Therapy R&D, Likarda, discuss the benefits of hydrogel encapsulation in drug delivery and enhancing the bioavailability and functionality of cell therapies.
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FDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
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The year ahead for RNA therapeutic development and manufacturing
As the industry prepares for a new year, Dr Kate Broderick, PhD, Chief Innovation Officer of Maravai Life Sciences and TriLink Biotechnologies, shares her thoughts on what the RNA therapeutics landscape of 2024 can tell us about what may be on the horizon in 2025.
