All Medicines and Healthcare Products Regulatory Agency (MHRA) articles
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ArticleRegulating decentralised manufacturing in the UK – a legal perspective
Harry Jennings, Partner at VWV, discusses the UK's new framework governing point of care (POC) and modular manufacturing and its implications for manufacturers and marketing authorisation holders in the UK.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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NewsAstellas secures EC approval for VMS treatment, fezolinetant
Approval of fezolinetant gives patients in Europe a new nonhormonal treatment option to control hot flashes or night sweats associated with menopause.
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NewsMHRA authorises Mounjaro for weight management
The UK MHRA has authorised Eli Lilly's Mounjaro (tirzepatide) for weight loss and weight management in adults.
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NewsMHRA authorises alopecia treatment
UK patients with severe alopecia areata could access Pfizer's enzyme inhibitor, Litfulo (ritlecitinib), to help treat their condition.
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NewsMHRA regulation overhaul: new scheme for lowest-risk UK clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) states its new scheme enables a more streamlined approach to processing Clinical Trial Authorisations (CTAs) for initial applications in late-stage clinical trials.
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NewsGuidance for medicine packaging under Windsor Framework
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance to support implementation of new requirements for medicine packaging in 2025 under the Windsor Framework.
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NewsRoche subcutaneous cancer immunotherapy granted MHRA approval
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain on the NHS reduces treatment time to under ten minutes.
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NewsInnovation passport designation awarded to Pfizer and Arvinas
As the next stage of their co-development of vepdegestrant, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Pfizer and Arvinas its Innovation Passport to advance development of the oestrogen receptor (ER) degrader for ER+HER2- breast cancer.
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ArticleInternational regulation: the importance of quality assurance in drug development
Raquera Brown, Executive Director of Quality at Zymeworks offers quality and compliance professionals advice on how to navigate the often-complex regulatory space during development of innovative drugs like antibody therapeutics.
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NewsEli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
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ArticleRecent developments in stem cell therapies
EPR explores recent developments in stem cell therapies across several hard-to-treat diseases and how technology is transforming ATMP manufacture.
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News£277m investment to advance UK life sciences manufacturing
Four UK life sciences companies are set to benefit from a £277m investment in the first tranche of Life Sciences Innovative Manufacturing Fund (LSIMF) grants.
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NewsMHRA authorises BRUKINSA® in Great Britain for two cancers
BRUKINSA® (zanubrutinib) has been authorised by the MHRA for chronic lymphocytic leukaemia and marginal zone lymphoma in Great Britain.