AstraZeneca metastatic breast cancer treatment secures FDA approval
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
Archives for May 10, 2022
FDA outlines benefit-risk approach to drug or biologic product quality assessment
The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
Contract manufacturing issue holds up Regenxbio’s Duchenne gene therapy trial
Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contract manufacturer.
Inventprise inaugurates manufacturing facility for pneumococcal conjugate vaccines
Inventprise has inaugurated its new manufacturing facility for high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for low- and middle-income countries.
Cytiva opens Swiss manufacturing facility and Center of Excellence for cell and gene therapies
Cytiva is opening a new 7,400m² manufacturing facility in Grens, Switzerland this month: which will serve as a center of excellence for the company’s cell and gene therapy business as well as a being a base for European customer training programs.