article
Prodrugs: seeking perfection in an imperfect world
Balancing safety, efficacy and cost in drug development is challenging. Prodrugs offer potential solutions, but also introduce additional complexities, as Dave Elder explains.
List view / Grid view
Regulation & Legislation
whitepaper
Advertorial: Next-generation microbial testing of pharmaceuticals
Specialised microbial testing is key in drug development to mitigate contamination risks, which threaten drug efficacy and patient safety. Bruker's MALDI Biotyper® at MPL, Austria, ensures accurate and robust testing, in a high-throughput workflow, delivering reproducible results.
whitepaper
Application note: Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products
Ambili Menon, Pharma Quality Control, bioMérieux Inc. addresses the task of microbiological testing for advanced therapeutic medicinal products.
whitepaper
Application note: Validating recombinant cascade reagents in 3 simple steps
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
article
Guide 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.
article
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.
article
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New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
article
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.
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
Press Release: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
SGS’s Birsfelden, Switzerland lab is now a “one-stop shop” for biopharma firms in GMP/non-GMP analytics, featuring a new stability studies capability.
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
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
ABPI embraces proposals for pharma’s growth ahead of UK elections
The UK pharmaceutical industry body has invited proposals on economic investment, support for manufacturing, clinical trials and R&D.
news
EFPIA sets out targets for pharma environmental sustainability
To drive environmental sustainability in pharma, EFPIA strives “to go beyond compliance on the targets set within the various EU legislative requirements as part of the EU Green Deal initiatives under the Zero Pollution, Circular Economy and Climate Action plans”.
