More news – Page 62
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NewsBioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
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NewsClinical research organisation market anticipated to reach $140bn by 2033
According to a report, growing demand for cost-effective and efficient drug development processes is propelling the global clinical research organisation (CRO) market.
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NewsPDA revises report on glass container manufacturing
Parenteral Drug Association (PDA)'s 2023 technical report on nonconformities in glass containers during pharmaceutical manufacturing represents best practices for identification and classification.
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NewsEuropean Commission extends approval of cystic fibrosis medicine
For the first time, a medicine to treat the most common form of cystic fibrosis has been approved in paediatric patients aged one to under two years old.
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NewsNovel oral therapy shows potential in plaque psoriasis
"Development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm” in moderate-to-severe plaque psoriasis (PsO), stated a Janssen R&D VP.
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NewsISO publishes standard on bacterial endotoxin testing
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
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NewsCould small molecule medicine treat rare liver disease?
A novel PPAR alpha/delta agonist “could provide an important new therapeutic option for long-term treatment [of primary biliary cholangitis (PBC)].
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NewsFDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
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NewsGlobal PAT market expected to exceed $10b in 2032
Digitalisation is a driving factor for the global process analytical technology (PAT) market, according to a report.
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NewsFirst gene therapy approved for Haemophilia A
The first approved gene therapy for haemophilia A reduced the mean annualised bleeding rate from 5.4 bleeds to 2.6 bleeds per year in a clinical study.
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NewsFirst cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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NewsFirst AI-generated small molecule drug enters Phase II trial
Insilico Medicine’s novel AI-generated small molecule inhibitor drug represents a new milestone in pharmaceutical drug development.
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NewsEli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
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NewsUK trial to test psilocin-based drug for major depressive disorder
A first-of-its-kind trial testing a novel psilocin-based drug for major depressive disorder has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
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NewsCould obicetrapib facilitate sufficient LDL-cholesterol levels?
Data shared at the National Lipid Association (NLA) Scientific Sessions 2023 demonstrated that obicetrapib with ezetimibe reduced low-density lipoprotein cholesterol (LDL-C) while increasing HDL-C, compared with high-intensity statin monotherapy.
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NewsHPLC market projected to value $8 million by 2030
Research has shown that the global high-performance liquid chromatography (HPLC) market is being driven by the need for precise analytical tools in drug development and quality control (QC).
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NewsAlzheimer’s vaccine granted Fast Track designation
The US FDA has given Fast Track designation to an active immunotherapy vaccine that “specifically targets the most toxic forms of amyloid beta (Abeta)”.
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NewsFMF World Congress 2023: Janssen shares new data in HDFN
If approved, nipocalimab would be the first anti-FcRn therapy for EU pregnancies at high risk of haemolytic disease of the foetus and newborn.
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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.