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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In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
3 February 2025 | By ACD Labs
Learn about available formats for analytical data standardization, limitations, and how to ensure data is usable by lab scientists and AI/ML.
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.
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.
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.
29 January 2025 | By European Pharmaceutical Review, sponsored by 908Devices and Bruker BioSpin
During this virtual panel, industry experts will explore the latest developments and biggest challenges in process analytical technology (PAT) today.
The new data highlights the potential of the ItovebiTM (inavolisib)-based regimen as a new standard of care in advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer.
Cutting-edge science and large international investment are driving growth in the UK’s biotech sector, the organisation’s new report reveals.
The US$570m investment will contribute to advancing AstraZeneca’s global clinical pipeline, a key goal of its strategy to 2030.
24 January 2025 | By
Discover how Bruker Benchtop NMR integrates with synTQ software, enhancing process monitoring and complementing IR and Raman techniques in the PAT framework
The Phase II study validated an “incredibly safe bleeding profile” for Factor XI inhibitors as a treatment for the common cardiovascular condition.
J&J’s standalone small molecule drug was approved based on evidence of improvement of depressive symptoms without the need for patients to take a daily oral antidepressant.
Cell and Gene Therapy Catapult's (CGT Catapult) findings attest to the UK remaining “a highly attractive destination for clinical trials”.
Sarah Moores, Global Sustainability Director at AstraZeneca, discusses the potential scope for establishing electronic product information (ePI) in the pharmaceutical industry to support its endeavours in environmental sustainability.
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”.