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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.
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Regulation & Legislation
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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.
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New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.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 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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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.
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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…
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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.
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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.
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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”.
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First-in-class telomerase inhibitor approved for blood cancer
The FDA’s regulatory approval of the telomerase inhibitor is welcome, considering the high unmet need for many lower-risk myelodysplastic syndromes (LR-MDS) patients, according to Geron.
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Case Study: Franz Ziel’s utilisation of Enzyme Indicators using Fractional Kill Time method
3 June 2024 | By
An EJPPS published study on Enzymatic Indicators in Vaporized Hydrogen Peroxide Decontamination Cycles: Application-related Research focusing on Fractional Kill Time (FKT) and Reverse Fractional Kill Time (RFKT) Studies
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Oligonucleotide ALS therapy approved in EU
The European Commission (EC) has granted Biogen its third rare disease treatment approval in the European Union.
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Pharma Horizons: Cell and Gene Therapy
This report is dedicated to exploring some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.
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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
