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Unique testing regimen could prevent nuclease contamination
Biannual routine testing in the laboratory reduces both the likelihood of nuclease contamination occurrence and its impact, a study suggests.
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AACR: BTK degrader could treat CNS B-cell malignancies
New data suggests the small molecule therapeutic could also benefit autoimmune disorders with involvement in the central nervous system, such as multiple sclerosis.
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Advancing microbiome innovation
In the fourth instalment of EPR's ‘Microbiome therapeutics: microscope to medicine’ series, Emilie Plantamura, Deputy Chief Medical Officer at MaaT Pharma, examines the promising potential of microbiome therapeutics beyond Clostridium difficile infection, particularly in the onco-haematological field.
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Achieving FAIR bacterial identification
A study has reported a noninvasive assay for detecting Gram-negative bacteria biofilms that do not disrupt the pattern of bacterial growth.
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Innovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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The role of outsourcing in antibody drug manufacture
While manufacturing capacity was a major challenge in early development of monoclonal antibody drugs (mAbs), outsourcing to CDMOs likely helped to remedy this, research reports.
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Antibody-immunotherapy treatment shows benefit in serious endometrial cancer
The novel combination cancer therapy facilitated “exceptional” responses in some patients enrolled in a Phase II study for endometrial cancer.
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mRNA therapy could provide intracellular protein replacement for rare disease
With no treatments approved for propionic acidaemia, Moderna’s LNP-encapsulated mRNA therapy could offer a new therapeutic option for patients, new data suggests.
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First-in-class anaemia therapy granted expanded approval
The expanded authorisation of Reblozyl is based on a Phase III trial which showed that the treatment nearly doubled the percentage of certain transfusion-dependent anaemia patients achieving haemoglobin increase, compared to epoetin alfa.
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Championing UK ATMP clinical trials
In this Q&A, Jacqueline Barry, Chief Clinical Officer for Cell and Gene Therapy Catapult, elucidates on how the Advanced Therapy Treatment Centre (ATTC) Network can strengthen UK ATMP clinical trials.
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ADC oncology acquisition to address solid tumours
The acquisition will give Genmab worldwide rights to three clinical candidates including a potential best-in-class folate receptor alpha (FRα)-targeted ADC for ovarian cancer.
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Lonza appoints new Chief Executive
The incoming CEO of the contract development and manufacturing organisation (CDMO) Lonza will transition into his new role over Summer 2024.
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Endotoxin testing: the international regulatory landscape
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
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One-time gene therapy could improve wet AMD
A Phase I/IIa trial suggests that a subretinal gene therapy for wet age-related macular degeneration (wet AMD) could reduce the need for patients to receive anti-VEGF injections.
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Novel LAI antipsychotic approved in EU
The long-acting injectable (LAI) formulation is indicated as a once-every-two-months treatment for adults with schizophrenia.
