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With its novel approach for addressing a fundamental cause of eosinophilic esophagitis, approval of the biologic marks a potential new standard of care for paediatric patients.
The draft strategy, open for an eight-week public consultation, will help guide the direction of the network over the next few years.
This article explores the benefit of NOX inhibitors for fibrotic diseases and cancers and highlights the potential of Calliditas Therapeutics’ drug setanaxib, including its application in wider related indications.
Dr Mehrdad Mobasher, Chief Medical Officer for Hematology, BeiGene, discusses the evolution of therapies for chronic lymphocytic leukaemia (CLL), the promise of targeted treatments and what could be on the horizon of the therapeutic landscape for this disease.
Botanical drugs, also known as traditional herbal therapies, have long been used, but obtaining regulatory approval for these medicines, or therapies, is convoluted. Often manufacturers will market their botanical drugs as dietary supplements or traditional therapies, designations that require far less regulatory approval than marketisation as a drug. In this…
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…
Expansion of the WLA framework means that the largest number of regulatory agencies for medical products are approved as WHO Listed Authorities.
Considering reduced global demand for COVID vaccines, AstraZeneca has deemed there is no long-term value in investing in manufacturing the adenovirus-based vaccine.
EMA has recommended granting a marketing authorisation for Emblaveo for treatment of infections caused by multidrug-resistant bacteria.
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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).
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
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…
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
