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Parkinson’s infusion treatment demonstrates advantage over oral delivery
Delivering the traditional Parkinson’s treatment via subcutaneous infusion over a 24-hour period was shown to be safe and effective, research found.
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Drug Safety
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Mycoplasma testing market expected to value nearly $2 million by 2031
Technology innovations and a stronger focus on developing novel drugs to treat chronic diseases, are key drivers for the global mycoplasma testing market up to the next decade, research states.
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Analytical technique may advance medical cannabis quality control
Combining near-infrared spectroscopy (NIR) hyperspectral imaging (HSI) and machine learning could offer a simpler, non-invasive alternative to established analytical techniques such as chromatography, research suggests.
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FDA approval could shape liver disease treatment landscape
A novel liver therapy authorised under US Food and Drug Administration (FDA) Accelerated Approval, is a potential game-changer in the NASH treatment space.
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Developing a new treatment paradigm for IgAN
On World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics explores the challenges of treating kidney disease and shares why the company’s lead candidate could become the first self-administered B-cell modulation therapy.
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Rapid pseudomonas aeruginosa detection method developed
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
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J&J reveal long-term data for novel oral peptide
The new data suggests the IL-23 receptor antagonist peptide has potential to address the high unmet need of a durable and convenient oral option in moderate-to-severe plaque psoriasis.
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Live biotherapeutic products: bridging innovations and challenges in manufacturing
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
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Data integrity considerations in pharma and life sciences
In this Q&A, data expert Joseph S Boakai addresses decisive factors impacting data integrity in the pharma and life sciences industries.
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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.
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Preventing 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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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).
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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.
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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.
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Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
