All Therapeutics articles – Page 28
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NewsDigital simulations could advance nanoparticle drug delivery
Findings from the mathematical model could support development of personalised treatments, the research suggests.
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NewsCHMP meeting highlights - June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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NewsInnovative small molecule shows promise in obesity
The GLP-1 receptor agonist demonstrated good safety and tolerability in both healthy and overweight/obese adult participants, the Phase I study found.
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ArticleContinuous manufacturing: an evolving technology for drug substance manufacturing
Continuous chemical manufacturing technology has been in use for more than 100 years producing high-volume commodity chemicals. However, it was not until the early 2000s that the technology caught the attention of the pharmaceutical industry in a significant way.
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ArticleCombining biofermentation and chemical synthesis to manufacture complex molecules in pharmaceutical applications
It is well known that nature, being a rich source of bioactive natural products, offers up a massive number of candidate drugs for the pharmaceutical industry. David Blanco, Industrial BD and CDMO Director at Suanfarma CDMO, reveals why biofermentation benefits from additional processing to produce a viable drug candidate.
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ArticleGuide to Data Integrity 2024
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
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ArticleQA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
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ArticleEuropean Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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NewsNew draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
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ArticleDrug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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NewsNew US fill finish facility receives $4.1 billion investment
Novo Nordisk plans to allocate $6.8 billion towards production to expand its overall US manufacturing capacity.
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NewsNew multiple sclerosis treatment option granted in EU
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
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NewsOptimising iPS cell-based platelet manufacturing scale up
Large-scale platelet manufacturing must consider turbulent energy and shear stress as well as the undesired turbulent flow space within a bioreactor, the paper concluded.
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NewsGilead small molecule demonstrates strong capability for HIV prevention
According to Gilead, the study is the first Phase III HIV prevention trial to demonstrate a zero-infection rate.
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NewsSemi-automation of manual interventions in high-speed filling lines
Research has highlighted the potential of using robotics for isolator filling line interventions, enabling gloveless executions by operators.
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ArticleBig potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about ...
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NewsNon-chemotherapy lymphoma treatment may provide durable remission
Fifty four percent of evaluable patients with DLBCL attained a substantial tumour reduction with the five-drug regimen, trial data shows.
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WebinarDefining the right digital strategy for oncology: What do you want to measure?
In this webinar, find out how to optimise oncology clinical trials using digital tools to accelerate decision-making.
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NewsNovel immunotherapy combination approved for endometrial cancer
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
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NewsJ&J commits five-year investment in Italian medicine manufacturing
Currently, the Latina site exports 97 percent of the medicine it produces, according to Johnson & Johnson Innovative Medicine.