The FDA has said it cannot approve MSD and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate (ADC) patritumab deruxtecan because of problems at a third-party manufacturer.
It has been a good week for CSL Behring as it rolls out haemophilia B gene therapy Hemgenix, with positive reimbursement decisions in both the UK and Denmark.
Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.
Three of the four UK nations have agreed a long-term deal with Vertex Pharma for reimbursement of its cystic fibrosis therapies, ensuring permanent access to the drugs for eligible patients
Daiichi Sankyo has a second approval in Japan for Ezharmia, its first-in-class dual EZH1 and EZH2 inhibitor, as a treatment for relapsed or refractory peripheral T-cell lymphoma (PTCL).
Bristol-Myers Squibb’s KRAS inhibitor Krazati has been approved for a second indication, colorectal cancer (CRC), which could inject some much-needed sales growth into the product.