All Industry Insight articles – Page 35
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NewsPreventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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NewsSemaglutide 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).
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NewsThe 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.
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NewsEmploying 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.
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NewsUK 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.
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ArticleThe future of targeted alpha therapy development and manufacture
Following the first industrial-scale facility for targeted alpha therapy (TAT) production in Europe beginning construction, in this exclusive Q&A, Julien Dodet, CEO of Orano Med, elaborates on the key trends in radioligand therapeutics and why TATs hold significant advantages as cancer treatments.
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NewsNew 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.
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NewsSandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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NewsMedical 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.
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NewsNew 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.
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ArticleAnalytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum ...
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NewsNew 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.
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NewsNew 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.
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NewsJoint 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.
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NewsNICE recommends first licenced treatment for AL amyloidosis
Having been available in Scotland and Northern Ireland since 2022, NICE’s positive opinion of the combination treatment means it is now accessible on the NHS.
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ArticleRare disease spotlight: first EU-approved treatment for Friedreich’s ataxia
In this exclusive article, Biogen’s Vice President and Head of the Neuromuscular Development Unit, Dr Toby Ferguson, discusses the current rare disease landscape and recent developments in treating Friedreich’s ataxia (FA).
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NewsImplications of AI regulation for data integrity
According to research, organisations should invest in training for those working with artificial intelligence (AI) to support data integrity assurance in AI applications.
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NewsMHRA Chief Executive to step down
During Dame June Raine’s five-year tenure as Chief Executive, MHRA delivered regulation facilitating key innovations in gene therapy and the world’s first COVID vaccine.
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NewsAmgen opens its most advanced manufacturing facility to date
The biomanufacturing facility has been designed to help Amgen meet its target of carbon neutrality in all its operations by 2027, according to the company.
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NewsBoehringer reveals major data from liver disease trial
Data suggests Boehringer Ingelheim’s novel glucagon/GLP-1 receptor dual agonist could become a best-in-class liver disease treatment for metabolic dysfunction-associated steatohepatitis (MASH).