All articles by CE – Page 36
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NewsEuropean Commission approves novel antibiotic
Authorisation of the antibiotic combination, which targets multidrug-resistant bacteria, could help to address the global challenge of antimicrobial resistance (AMR).
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NewsUtilising rapid UHPLC for tablet QC analysis
The proposed UHPLC method is suitable for routine quantitative analysis of teneligliptin and pioglitazone, a paper reports.
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NewsWidening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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NewsMicrobial 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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NewsGenentech 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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NewsEnhancing 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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NewsAntibiotic 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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NewsAnalysis of corticosteroid formulations in metered dose inhalers
The spectrophotometric-based method offers rapid and reliable analysis of formoterol and beclomethasone formulations in metered dose inhalers, according to research.
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NewsUsing 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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NewsEncouraging 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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NewsTechnology advancement driving growth of rapid sterility testing market
Rising demand for sterility tests and an expanding biotechnology industry is set to boost growth of the rapid sterility testing market between 2023 and 2032, a report states.
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NewsNovartis 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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NewsEuropean and Japanese Pharmacopoeias partner to harmonise pharmacopoeial standards
During the project, the European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP) will discuss the challenges in expanding the harmonisation of pharmacopoeial standards to both active substances and medicinal products.
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NewsTeva 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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NewsLong-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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NewsFUJIFILM plans $1.2 billion investment in major US manufacturing facility
Proposed additions to the cell culture manufacturing facility are set to make the site one of the largest cell culture biopharmaceutical CDMO facilities in North America.
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NewsSeasonal variation of microbial contamination in pharmaceutical cleanrooms
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
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NewsNovel 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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NewsCRISPR 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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NewsEFPIA reaction to European Parliament plenary vote
Following the recent European Parliament plenary vote, EFPIA asserts that aligning the next revision of the pharmaceutical legislation to increase Europe’s competitiveness will be a challenge.