news
Novel immunotherapy approved for melanoma
The first non-CAR-T adoptive cell therapy to reach the market has been approved by the US Food and Drug Administration (FDA).
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Regulation & Legislation
webinar
Process analytical technology: applications and opportunities for pharma
15 February 2024 | By European Pharmaceutical Review, sponsored by Mettler Toledo, Bruker and 908Devices
During this virtual panel, industry experts will discuss the latest advances and applications of process analytical technology in the pharmaceutical sector.
news
USP recommends revisions to proposed RMM chapters
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
news
Vertex secures European approval for CRISPR cell therapy
Now conditionally approved in Europe for sickle cell disease and transfusion-dependent beta thalassemia, the CRISPR therapy offers eligible patients a functional cure.
news
EMA Annex 1 Q&A discusses bioburden considerations
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).
news
US legislation to benefit small molecule drug innovation
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.
webinar
Mastering Pharma 4.0 validation challenges with technology
2 February 2024 | By Kneat Solutions
In this webinar Kneat Solutions’ Director of Consulting, Marcus Ryan, discusses the best way forward in the evolving world of Pharma 4.0™, revealing how companies can overcome validation complexities with technology.
podcasts
EPR Podcast 22 – Pharmaceutical packaging – Manu Kittanakere, Gilead
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.
news
CHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
news
Revised ISO guideline highlights toxicological evaluation of extractables and leachables
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
news
Medicines for Europe calls for simpler SPC manufacturing waiver
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.
article
Pharmaceutical industry: 2023 in retrospect
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
news
Eosinophilic esophagitis medicine approval expanded
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.
article
Bridging the healthcare digital divide: a gradual approach to adopting ePI
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…
news
NICE recommends innovative breast cancer drug
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).
