Pharmaceutical Market Europe • January 2026 • 7
NEWS
CGT Catapult establishes industry safety consortium for cell therapies
CGT Catapult, an independent technology organisation specialising in the cell
and gene therapy (CGT) industry, has established ReCell, a consortium focusing on safety tests for a range of cell therapies.
Pluripotent stem cells (PSCs) can be used in a number of advanced therapies, such as cell replacement and regeneration, adaptive or genetically modified interventions, and targeted therapeutic approaches, as they have the capacity to differentiate into many clinically relevant cell types. However, there is also the risk that if there are any undifferentiated PSCs remaining in a therapy, this could cause uncontrolled proliferation and tumour formation.
There is currently no universal test that drug developers can use to ensure that products are free from residual PSCs, requiring each developer to create
their own individual product tests.
This is costly and lengthens the amount of time a treatment is in development.
ReCell’s aim is to test whether droplet digital PCR methods are able to detect residual PSCs in various therapy products.
The first test has been co-developed by CGT Catapult and the Health and Environmental Sciences Institute’s (HESI) Cell Therapy Tracking, Circulation, and Safety committee.
AstraZeneca’s Saphnelo shows positive results for lupus
AstraZeneca’s Saphnelo (anifrolumab) as a subcutaneous (SC) treatment has been found to significantly reduce disease activity in systemic lupus erythematosus (SLE) patients.
Trial results from the phase 3 TULIP-SC trial, published in Arthritis & Rheumatology, showed that 56.2% of patients treated with SC Saphnelo achieved disease activity reduction at week 52 of the study, compared to 37.1% of patients receiving placebo.
The safety profile of SC Saphnelo was found to be consistent with the established profile of intravenous (IV) Saphnelo. The treatment was well tolerated, and patients in the treatment and placebo arms of the study experienced comparable adverse events.
SLE is a chronic autoimmune disease where the immune system attacks healthy tissue. More than 3.4 million people globally are affected by the condition. Symptoms caused by SLE include pain, rashes, fatigue, joint swelling and fever, and around half of SLE patients suffer irreversible organ damage in the five years following diagnosis.
Reducing disease activity in SLE allows patients to reduce chronic use of oral corticosteroids (OCS), which can in turn lower the risk of organ damage.
GSK’s Nucala approved by MHRA for uncontrolled COPD
by the MHRA to treat adults with uncontrolled chronic obstructive
pulmonary disease (COPD).
Around three million people in the UK suffer from COPD, which includes emphysema (damage to the air sacs in the lungs) and chronic bronchitis along with other lung conditions as a result of inflamed or damaged lungs and airways. It is the second most common cause of emergency hospital admissions and the leading cause of re-admissions in the UK.
The MHRA’s approval is based on results from the phase 3 MATINEE and METREX trials of Nucala as a COPD treatment. In both trials, treatment with Nucala alongside triple therapy demonstrated statistically significant reduction in the rate of moderate to severe disease exacerbations compared to placebo.
In the MATINEE trial, Nucala showed a 35% reduction compared to placebo
in the rate of exacerbations leading to hospitalisation or emergency department visits, although this secondary endpoint was not considered statistically significant.
The safety profile of Nucala in both studies was found to be consistent with the drug’s established safety profile in other indications.
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