Huntington’s gene therapy research has reached a turning point, expert says
Despite unanticipated regulatory hurdles following promising clinical results with a novel investigational treatment for Huntington’s Disease, the significance of the…
Despite unanticipated regulatory hurdles following promising clinical results with a novel investigational treatment for Huntington’s Disease, the significance of the…
In August 2025, the US Food and Drug Administration’s (FDA) launched the nationalised entry review (NER) programme focused on centralising…
Next month, clinical development and clinical operations professionals will gather and discuss the current challenges in running clinical trials for…
Pharma companies will need to rethink business and research and development (R&D) strategies to mitigate against the global impact that…
Although the regulatory landscape for advanced therapy medicinal products (ATMPs) is rapidly evolving, varying regulatory requirements across different regions are…
Innovation in neuropsychiatry has been dormant for nearly forty years, said Kabir Nath, CEO, Compass Pathways in a panel discussion…
“Consumer demands drive flexible and optimised manufacturing processes and also infrastructure,”said Catarina Abreu, Head of Nutraceuticals at PIPA AI. At…
Drug impurities such as nitrosamines can often contaminate drugs leading to recalls and regulatory actions given their carcinogenic nature. These…
Innovative cell and gene therapies (CGTs) have significantly disrupted the treatment landscape for several genetic diseases. In recent years, the…
Cell therapies stand at the frontier of medicine and hold the potential to potentially cure diseases, said Angela Vollstedt, global…