news
Widening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter < 86 > on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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Research & Development (R&D)
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Microbial burden assessment of solid pharmaceutical products
Employing an automated, alternative microbiological method (AMM) means water activity could be used as a microbial indicator for bioburden assessment in tablets and capsules, a study suggests.
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Genentech oncology treatment granted first-of-a-kind approval
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
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Webinar: How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation
Melanie Eggers is a Sterilisation Validation Project Support Engineer at Pfizer Belgium. In this webinar, she explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the…
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Enhancing competitiveness of European life sciences
EFPIA’s reflections on the recent Conclusions of the Special Meeting of the European Council assert the importance of ensuring a more resilient and competitive life sciences sector.
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Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment
Based on its novel mechanism of action, GSK’s gepotidacin could provide a new oral option for the treatment of gonorrhoea.
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Using mass spectrometry to improve quality and safety of levothyroxine
A study investigating levothyroxine has reported a new non-targeted analytical approach for pharmaceutical quality control analysis.
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Encouraging data for Roche multiple sclerosis injection
EU approval for Roche’s subcutaneous OCREVUS is anticipated mid-2024, depending on acceptance of regulatory submission.
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Novartis releases new data for innovative rare kidney disease treatment
Data from the pre-specified interim analysis of Fabhalta® (iptacopan) indicate a statistically significant reduction in proteinuria reduction.
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Teva enters into oncology biosimilar licensing agreement
The agreement between Teva and mAbxience for the oncology biosimilar candidate will help to reduce costs within healthcare.
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Long-term data indicates “significant” potential of aGvHD microbiome treatment
In third line, MaaT013 represents the highest overall survival in acute graft-versus-host disease (aGvHD) when compared to reported literature evidence, according to MaaT Pharma.
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Novel medicine could address short stature in children
Some patients had excellent responses in Phase II of an innovative trial of vosoritide in paediatric hypochondroplasia, data shows.
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CRISPR technologies fuelling haematological innovations
Greater use of CRISPR-based therapies in clinical trials is expected to drive further advancements in precision medicine, GlobalData states.
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Low dose injectable could aid prenatal depression
Research suggests that for every five mothers given low dose esketamine, one major depressive episode could be prevented.
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Patent expiration to drive biosimilars market expansion to 2032
Cost effectivity of biosimilars is predicted to be a key contributor to growth of the global biosimilar market to 2032, research states.
