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At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
Under the agreement, Recipharm will help advance two inhaled medicines intended for asthma and chronic obstructive pulmonary disease (COPD).
Privately-owned Grünenthal estimates the Nebido brand will add about €100 million to its EBITDA in 2023.
Results from several haemophilia trials have been presented at the International Society on Thrombosis and Haemostasis (ISTH) Annual Congress 2022, here EPR summarises some of the key developments.
Phase III trial data shows Dupixent® (dupilumab) has the potential to improve signs of eosinophilic oesophagitis (EoE) and support healthy weight gain in children with the condition.
Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-300x278.jpg)
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-e1657792683882.jpg)
The voluntary US-wide recall of Lot DX9067 of Propofol Injectable Emulsion, USP is due to the possible presence of visible particulate with potentially harmful effects.
In this Q&A, Bryan Kobel, Chief Executive Officer of TC Biopharm, discusses innovations in cell therapies, introducing the company’s work in gamma delta (γδ) T-cell technologies and his predictions for the future of cell therapy development.
AstraZeneca announces plans to acquire TeneoTwo and its CD19/CD3 T-cell engager, TNB-486, in a deal worth up to $1.2bn.
![Sanofi logo on top of building [Credit: HJBC/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sanofi-1-300x278.jpg)
![Sanofi logo on top of building [Credit: HJBC/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sanofi-1.jpg)
Sanofi Global Health — a nonprofit unit of Sanofi set up in 2021 — has launched Impact®, a new brand of standard of care medicines dedicated for nonprofit distribution in 40 of the world’s lower-income countries.
Study highlights benefit of initiating high-efficacy therapies early for relapsing multiple sclerosis (RMS) patients, as opposed to changing from lower efficacy therapies later.
Handling highly potent active pharmaceutical ingredients (HPAPIs) or drug product in a laboratory requires implementation of strict security measures. Here, Elodie Barrau and Olivia Jones discuss high potency product handling procedures to ensure continued safety.
