FDA warning letters highlight data integrity issues
Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
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Inlet air conveyor optimisation in a continuous tablet coater
An inlet conveyor with a linear diffuser inside a continuous tablet coater offers better air flow distribution for tablet drying, research by IMA Pharma suggests.
Manufacturer retracts acquisition deal due to “data integrity issues”
According to Olympus Corporation, concerns about the non-vascular metallic stents were found post-closing following the agreed acquisition of Taewoong Medical Co., Ltd.
Preventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
Semaglutide could provide novel dual benefit in diabetes and kidney disease
The new data suggests Novo Nordisk’s small molecule treatment semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD).
The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance
By ensuring accurate and reliable data in drug development, data integrity supports regulatory compliance and drug safety, a paper explains.
Employing MALDI-TOF MS for microbial identification in sterile drug manufacturing
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
UK manufacturing and R&D to benefit from new £360m investment
A joint government and industry investment of £92 million intended to expand UK medicine manufacturing facilities, form part of a new £360 million funding package from the UK government.
New radiopharmaceutical laboratory opens in Germany
Ariceum Therapeutics’ new Berlin-based laboratory gives the company internal capability to progress the development of its lead radiopharmaceutical candidates.
Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
New BeiGene Head of Europe, Global Clinical Operations appointed
Bringing over two decades of experience in oncology clinical development, the biotech’s new hire will work to advocate for innovation and patient-centric clinical development for the company’s European initiatives.
New data revealed for Novartis SMA gene therapy
Novartis has revealed new data for its one-time gene therapy for spinal muscular atrophy (SMA) in older children.
New antibody drug formulation wins novel MHRA approval
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
Joint investment to accelerate UK sustainable biomanufacturing
One project supported through £11.5 million investment will focus on biocatalytic nitro-reductions in scalable continuous flow reactors, using paracetamol as a case study.
