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Pfizer’s bivalent Respiratory Syncytial Virus (RSV) vaccine candidate was 85.7 percent effective when administered to adults 60 years of age or older, according to top-line data from a Phase III trial.
European approval of BioMarin’s ROCTAVIAN (valoctocogene roxaparvovec) one-time gene therapy represents a breakthrough in the treatment of adults with severe haemophilia A.
A new approach leveraging high-yield CRISPR could make it easier to re-engineer massive quantities of cells for therapeutic applications.
Reviewing the active pharmaceutical ingredient (API) content in essential medicines failing quality analyses in low- and middle-income countries (LMICs) reveals that more than 12 percent are substandard or falsified.
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
It is difficult to treat cancer effectively without causing adverse side effects. In this article, Dr Li, Clinical Assistant Professor at the State University of New York and Board Director of ExonanoRNA, describes how an old strategy that never got off the ground has finally been leveraged to deliver safe,…
The problem of counterfeit medicines is becoming a tremendous burden to society. An edible security tag affixed to each medicine can provide track and trace measures with dose information and on-dose (in-dose) authentication. Furthermore, it serves as a last line of defence against illicit pharmaceutical products. Young Kim, Associate Head…
Study reveals lidding foil with nitrocellulose primer is a potential source of nitrosamine impurities for pharmaceuticals, especially when using plate sealing equipment.
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
Antibody-drug conjugates (ADCs) are designed to be highly-targeted therapies with the potential to maximise the potency of a treatment while reducing unwanted side effects on healthy tissues. Some 20 years after the first ADC product approval, Dominik Schumacher and Jonas Helma-Smets of Tubulis GmbH discuss how improved and optimised technologies…
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
Direct acting antivirals used to treat hepatitis C virus infection may improve symptoms of posttraumatic stress disorder (PTSD) in patients without the disease, according to new research.
bluebird bio’s Zynteglo (betibeglogene autotemcel), a one-time treatment for transfusion-dependent beta-thalassemia, will roll out with a $2.8mn price tag per dose.
The UK’s regulator approved Novartis’ radioligand therapy Pluvicto®▼ and radioactive diagnostic agent Locametz® for use in advanced prostate cancer.
MHRA approves Moderna’s adapted COVID-19 vaccine, Spikevax bivalent Original/Omicron, for use as a booster.
