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The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.
Following shortages of the diabetes medicine Ozempic (semaglutide), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed cases of falsely labelled pre-filled pens at UK and EU wholesalers.
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
With nitrite concentration in excipients being a key risk factor in nitrosamine drug substance related impurities (NDSRI) formation, there is opportunity to implement corrective and preventative actions (CAPAs), EMA experts say.
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
Novartis will remove its sickle cell medicine crizanlizumab from the EU/EEA market following a European Commission decision.
The European Commission (EC) has approved the first treatment for paediatric patients in the EU to treat seizures associated with CDKL5 deficiency disorder.
Cell-based therapies have the potential to regenerate heart tissue as an alternative to heart transplants. Here, Dr Ibon Garitaonandia, Chief Scientific Officer at CellProthera, shares how CD34+ cells are demonstrating promising results in clinical studies.
Transferring analytical methods between companies is often a challenging, time-consuming manual process. In this Q&A, Dr Birthe Nielsen, Project Lead at The Pistoia Alliance, speaks about an ongoing project to digitally transfer HPLC data between different vendors.
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
Public consultation is open for the European Medicines Agency (EMA)’s draft reflection paper on using artificial intelligence (AI) when developing and regulating medicines.
In this exclusive interview, Naser Al Yammahi, Deputy CEO of Hayat Biotech explores challenges facing the pharmaceutical supply chain, medicine shortages and looks at how technology advances will drive supply chain transformation.
