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QA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
List view / Grid view
Biopharma
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European 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.
news
New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
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Drug 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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New 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.
podcasts
EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions
In this podcast, Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions, discusses the current landscape and the best approaches for mitigating contamination and detecting nitrosamines.
news
New 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.
news
Optimising 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.
news
Gilead 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.
news
Semi-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.
article
Big 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…
news
Non-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.
news
Novel 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.
news
J&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.
news
AbbVie to advance TL1A antibody for IBD
The new, potentially multi-billion-dollar deal will help bring a next-generation therapy to patients with inflammatory bowel disease (IBD), an autoimmune condition.
