All articles by Catherine Eckford (European Pharmaceutical Review) – Page 52
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ArticleMicrobiome therapies: a maturing movement
On World Microbiome Day 2023, Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences delve into the current innovative landscape of microbiome-based therapeutics.
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NewsLonza and Vertex to partner to manufacture diabetes cell therapies
The proposed collaboration between Lonza and Vertex Pharmaceuticals will support manufacture of stem cell-derived, fully differentiated insulin-producing islet diabetes cell therapies.
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NewsFDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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NewsTAK-755 trumps plasma-based therapy, trial shows
Compared to plasma-based therapies, the only recombinant ADAMTS13 protein in development showed strong efficacy in a trial for congenital thrombotic thrombocytopenic purpura (cTTP), Takeda revealed.
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NewsHow can real-world evidence support regulatory decision making?
Strategies to further accelerate real-world evidence generation to aid EU regulatory decision-making are needed, states a European Medicines Agency (EMA) report.
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NewsFirst RNA CAR-T therapy autoimmunity trial shows potential
A novel RNA CAR-T cell therapy demonstrated long-term clinical benefit for most generalised myasthenia gravis (gMG) patients in a landmark study.
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NewsReducing bioburden testing and sterility testing volumes for gene therapies
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
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NewsGene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
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NewsNew approach for small molecule nanosimilar analysis reported
A study on the small molecule antibiotic rifabutin has highlighted benefits of mechanistic compartmental analysis in evaluating nanomedicines.
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ArticleAMR certification: recognising responsibly in antibiotic manufacture
Following the recent launch of the BSI’s AMR certification, EPR invited Steve Brooks from the AMR Industry Alliance and BSI’s Courtney Soulsby to elucidate its significance for antibiotic manufacturers and the wider pharma industry.
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NewsNew mass spec technique identified for electron ionisation direct analysis
A paper has depicted extractive-liquid sampling electron ionisation-mass spectrometry (E-LEI-MS) as a new real-time MS technique for direct analysis.
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NewsFirst adult anti-inflammatory cardiovascular drug approved
An FDA-approved anti-inflammatory drug can reduce cardiovascular disease risk by an additional 31 percent in adults, on top of standard of care, clinical data has shown.
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NewsHow effective is nanopore sequencing for fungal identification?
A paper has described a DNA metabarcoding workflow that rapidly characterises fungal microbiota with high taxonomic resolution.
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NewsCould novel robotic oral pill replace traditional injections?
An osteoporosis study has demonstrated a high delivery success rate for a breakthrough technology that converts injections into an oral pill, data from ENDO 2023 showed.
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NewsHow can AI be best harnessed for pharmacovigilance data?
A GSK-funded paper on pharmacovigilance stated that the pharma industry needs to harness the properties of data to allow optimal use of AI, otherwise "we will fail to do all we can for patient safety".
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ArticleDigitalisation of the clinical trial landscape
UCB Pharma's Chief Medical Officer Iris Loew-Friedrich, shares her perspective on digital innovation in clinical trials plus current challenges in clinical data management and how it could evolve in the future.
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NewsFDA approves off-the-shelf bispecific antibody cancer therapy
The US Food and Drug Administration (FDA) has approved the first bispecific antibody with a fixed-duration treatment in (R/R) diffuse large B-cell lymphoma (DLBCL).
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NewsR&D innovation advancing small molecule innovator CDMO market
Accelerating advancement in research and technology is generating opportunities for biopharma to develop innovative small molecule drugs, a report shows.
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NewsWhy is microbiological testing in medical device manufacturing important?
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
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News6.1 percent CAGR expected for pharmaceutical sterility testing market
The rising importance of quality and sterility is expected to drive the pharmaceutical sterility testing market in the next decade, a report says.