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NICE recommends novel immunotherapy for leukaemia
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
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First-in-human data for gene therapy signals potential in childhood blindness
Developed and manufactured under a Manufacturer’s ‘Specials’ Licence (MSL), the gene therapy could provide a novel treatment option for paediatric patients at the earliest stage of the rare eye disease.
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Water-based reactors offer pharmaceutical industry a safer alternative to toxic solvents
The breakthrough promises to transform pharmaceutical manufacturing by enabling chemical reactions in water, reducing reliance on hazardous organic solvents.
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Innovating bioanalysis to advance oligonucleotide therapeutics
Here, Dr Jinpeng Li at WuXi AppTec reveals the analytical challenges that are hindering advancement of oligonucleotide therapeutics, medicines which have demonstrated clinical promise in the gene therapy space, and discusses promising analytical innovations.
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First-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
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Biologic could reduce treatment burden for children with haemophilia A
New data suggests that once-weekly prophylaxis bispecific antibody treatment could provide an efficient and convenient option for young patients with haemophilia A.
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Novel drug approved for diabetes-related vision loss
The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.
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Draft regulatory guidance on personalised cancer therapies published
The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
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Moderna reports record for UK clinical trials in 2023/24
The announcement follows the completed construction of Moderna’s MITC and progress in its long-term partnership with the UK government.
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MHRA approves SARCLISA for newly diagnosed multiple myeloma
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
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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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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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Biosimilar medicines: the intersection of access, affordability, and innovation
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.
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New analysis asserts survival benefit for Roche breast cancer therapy
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.
