All Data Analysis articles – Page 19
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NewsDriving QbD as a quality standard in drug development
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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ArticleUnderstanding the evidence used in drug product withdrawals
Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.
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ArticleNK cell immunotherapy: what’s next in clinical development?
In this interview, Innate Pharma’s Yannis Morel, Executive Vice President of product portfolio strategy and business development, delves into the unique advantages of using multi-specific antibodies capable of engaging NK cells against tumours for oncology indications, and shares key data from the company’s ongoing and recent clinical trials.
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NewsGSK immuno-oncology treatment achieves novel EU approval
The EC’s approval of the immuno-oncology treatment “will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU,” says principal investigator of the RUBY trial.
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NewsASH 2023: microbiome-based therapy shows potential in graft-versus-host disease
Data presented at the 2023 American Society of Hematology (ASH) Annual Meeting suggest that the off-the-shelf microbiome therapeutic could offer a “potentially life-saving approach” in graft-versus-host disease (GvHD).
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News'Innovation-first' mindset vital for advanced therapies sector future
Improving data harmonisation and investing in the advanced therapy sector’s workforce are some of the key recommendations the sector must take to advance the field and increase patient access, a new report highlights.
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NewsAntibody-immunotherapy combination shows promise in lung cancer
A study evaluating the combination of a PD1 inhibitor with dupilumab enabled one out of six lung cancer patients to achieve a near-complete clinical response two months post-treatment, a paper states.
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NewsPhase III data for novel telomerase inhibitor released
Currently, imetelstat is being reviewed by the FDA and EMA for the treatment of transfusion-dependent anaemia in adults with lower risk MDS.
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NewsNovel generalised myasthenia gravis treatment approved
A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.
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NewsCold storage market to value $383bn by 2032
The combination of tech innovation, automation, and sustainability is reshaping the landscape of cold storage solutions, research says.
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NewsFirst pill for desmoid tumours approved
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
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NewsLong COVID study expanded across Europe
If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.
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NewsVertex scores European cystic fibrosis medicine approval
Following a milestone approval by the European Commission in July 2023, Vertex Pharmaceuticals has been granted a label expansion for its cystic fibrosis medicine KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) with ivacaftor.
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NewsNew Amgen immunotherapy could treat common solid tumour
With demonstrated benefit in anti-tumour activity and overall survival in patients with small cell lung cancer, Tarlatamab could provide a new third-line option, a Phase II study suggests.
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OpinionDigitalisation and PAT: current landscape and future trends
In this exclusive interview from CPHI 2023, Mohamed Noor, Digitalization Manager at the National Institute for Bioprocessing Research and Training (NIBRT), explores the trends, challenges and opportunities that digitalisation and process analytical technology (PAT) have within the biopharmaceutical industry.
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NewsFully instrumented 3D printed small-scale bioreactor developed
To support upstream bioprocess development, a study has demonstrated real-time monitoring of the growth phase in a 3D printed, single-use bioreactor.
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NewsTrial for novel CGRP migraine medicine gleans positive results
The first pill designed to directly block calcitonin gene-related peptide (CGRP), a protein released during a migraine attack, has demonstrated positive evidence in AbbVie’s trial investigating its efficacy in the prodrome phase.
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NewsFirst CRISPR-based gene-editing therapy authorised
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a world-first regulatory authorisation to a medicine based on Nobel Prize-winning technology.
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NewsFDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).