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In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
Passing of two key legislations in the US is set to support innovation for small molecule drugs and the biotech sector, Biotechnology Innovation Organization (BIO) asserts.
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
In this podcast, Manu Kittanakere, Associate Director of Packaging Engineering at Gilead discusses the future of pharmaceutical packaging, including the growing importance of AI, automation and sustainability in packaging engineering.
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
As the global healthcare landscape moves towards a digital transformation, a balanced approach that unites electronic product information (ePI) with traditional paper leaflets can help ensure every European citizen, irrespective of their digital access, has unencumbered access to critical medical information. Here, Ataa Elfaquih from MLPS, a subgroup of the…
EPR's inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
16 January 2024 | By
The subcutaneous injection of the novel cancer immunotherapy Tecentriq® (atezolizumab) could provide a quicker alternative to intravenous infusion, research shows.
A new drug has been approved in the UK as a safer alternative to corticosteroids to treat Duchenne muscular dystrophy (DMD).
EPR speaks to Henry Levy, President, Life Sciences at Clarivate to gain a sense of how artificial intelligence (AI), and particularly Generative AI (GenAI), is transforming the pharmaceutical industry.
The first biosimilar to Stelara® is now approved in Europe, a biologic therapy with indications across gastroenterology, dermatology, and rheumatology.
Here, Chrysi Sergaki from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, explores how innovators and regulators can navigate the challenges affecting the development and regulation of microbiome therapeutics to bring safe and efficacious therapies to patients as soon as possible.
