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.
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.
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.
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.
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.
New partnership to aid supply of Ga-68-based radiopharmaceuticals
The new collaboration is set to ensure a steady, more accessible supply of Ga-68-based radiopharmaceuticals, thereby helping to address traditional logistical challenges due to gallium’s short half-life.
Biopharmaceuticals contributing to manufacturing outsourcing trend
A report has highlighted how the outsourcing of manufacturing activities to contract manufacturers is facilitating more streamlined and efficient pharmaceutical drug development.
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.
EP monographs allow rFC for water testing
As of 1 April, two European Pharmacopoeia monographs allow the use of rFC to test for bacterial endotoxins in pharmaceutical waters.
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.
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.
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.
Pharmaceutical environmental monitoring market to value $38.1b by 2030
Technological solutions such as real-time monitoring could help expand the pharmaceutical environmental monitoring market up to the next decade, research says.
Quality risk management in radiopharmaceutical production
A quality risk assessment of a Good Manufacturing Practice (GMP) radiopharmaceutical production site found that dispensing was the most critical phase of the process.
