Despite individual regulatory bodies having their own unique set of requirements, for most organisations, the challenges associated with annual product quality reviews (APQR) are largely the same. Issues with fragmented systems and paper-based processes prove increasingly burdensome.
To improve mRNA product analysis, the Lonza Group Ltd. and Oxford Nanopore Technologies plc. are working together to develop and market a test to assess multiple critical quality attributes of mRNA products
Dr Rob Scott, former Chief Medical Officer and Head of Development at AbbVie, joined Abionyx Pharma in January as new CMO and Head of Research and Development.
Enterprise Therapeutics Ltd. has raised £26m for the Phase IIa trial of ETD001, a novel cystic fibrosis treatment, with investment led by Panakes Partners and participation from existing investors.
AVT03, a biosimilar candidate for osteoporosis treatment, showed promise in treating bone illnesses, according to results from a pharmacokinetic study by Alvotech SA.
Danish Novozymes A/S and Chr. Hansen Holding A/S have completed their merger, creating a new company named Novonesis.
Following the AGRI Committee of the European Parliament, the lead ENVI Committee has also agreed to relax the rules for the authorisation of NGTs.
Uppsala-based ScandiNova Systems AB appoints Pernilla Enkler as the new Head of Sustainability, Quality and Communication – a newly established division.
Forbion has spearheaded a €75m Series A financing in Norwegian biotech Calluna Pharma. The clinical-stage company resulted from the merger of Oxitope Pharma and Arxx Therapeutics.
Genentech, Roche’s US subsidiary, is ending its decades-long collaboration with AC Immune SA after disappointing study results. It has handed the global rights to Crenezumab and Semorinemab back to the Lausanne-based biotech.