Dolutegravir shows promise in pregnancy
Study comparing commonly used antiretroviral regimens in pregnancy reports viral suppression at delivery in considerably more participants taking dolutegravir.
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Evolving real-time dissolution prediction and product release
EPR highlights the development of a model to predict dissolution of sustained release formulations based on Raman process analytical technology (PAT) sensor data that could enable real-time release testing.
EU regulators release new workplan for accelerating clinical research
The latest workplan outlines how innovation in clinical research will be facilitated over the next four years, including modernising good clinical practice and issuing guidance on decentralised trials.
Advancing autonomous API reaction optimisation
A novel flow reactor platform was able to self-optimise a range of variables within a multi-step reaction by leveraging process analytical technologies (PAT) and chemometric models.
Black participants make up just 3% in cancer clinical trials, says GlobalData
A new report indicates that black participants were severely underrepresented in global oncology clinical trial population, accounting for just three percent of patients from 2013-2022.
3D printing of starch-based tablets for personalised drug delivery
Drug release could be tailored by adapting the type of starch used and the tablet shape, highlighting the promise of 3D printing for future personalised drug delivery applications.
Pfizer’s RSV vaccine effective in older patients
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.
Europe approves first gene therapy for treatment of haemophilia A
European approval of BioMarin’s ROCTAVIAN (valoctocogene roxaparvovec) one-time gene therapy represents a breakthrough in the treatment of adults with severe haemophilia A.
Non-viral CRISPR could overcome cell and gene therapy bottlenecks
A new approach leveraging high-yield CRISPR could make it easier to re-engineer massive quantities of cells for therapeutic applications.
Moderna sues Pfizer and BioNTech over mRNA COVID-19 vaccines
Moderna alleges that Pfizer and BioNTech used its patented mRNA vaccine technologies in the Comirnaty® COVID-19 vaccine without its permission.
Assessing the scale of pharmaceutical crime using API content
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.
![Sandoz company logo on office building in Warsaw city centre [Credit: Konektus Photo/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sandoz-2-e1661424920546-300x278.jpg)
![Sandoz company logo on office building in Warsaw city centre [Credit: Konektus Photo/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sandoz-2-e1661424920546.jpg)
Sandoz to become standalone company
A spin-off from parent company Novartis aims to set Sandoz up as the premier European generics company.
Twice yearly HIV treatment approved in Europe
Gilead’s Sunlenca® (Lenacapavir) was authorised by the European Commission for people with multi-drug-resistant HIV who have very limited treatment choices.
Blister material as a source of nitrosamine impurities
Study reveals lidding foil with nitrocellulose primer is a potential source of nitrosamine impurities for pharmaceuticals, especially when using plate sealing equipment.
Can Hepatitis C drugs reduce symptoms of PTSD?
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.
