News round-up for 1-5 January by DDW Digital Content Editor Diana Spencer.
The start of 2024 has seen quite a bit of regulatory activity, with the UK MHRA’s launch of a new procedure for assessing drugs, along with significant regulatory approvals for therapeutics for cytomegalovirus, melanoma, amyloidosis and multiple sclerosis.
The top stories:
Takeda’s Livtencity (maribavir) has been approved in China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s advanced melanoma drug Opdualag (nivolumab-relatlimab) for patients from the age of 12.
The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new International Recognition procedure (IRP) will allow it to draw on the expertise of regulators in other countries when authorising medicines.
AstraZeneca and Ionis’ Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults (hATTR-PN or ATTRv-PN).
Kyverna Therapeutics has revealed plans to progress to Phase II trials of KYV-101 for multiple sclerosis (MS) following a green light from the US Food and Drug Administration (FDA).