Pfenex has provided an update on its bid to secure a therapeutic equivalence determination for its PF708 teriparatide product in the US, after itself and partner Alvogen were knocked back last month.
Pfenex’ manufacturing and marketing partner for follow-on Forteo (teriparatide), Alvogen, has “begun discussing next steps” with the US Food and Drug Administration after the agency last month served the firms with a notice to conduct further studies to prove that their PF708 teriparatide product is therapeutically equivalent to Eli Lilly’s reference product.
The FDA approved Pfenex’ hybrid 505(b)(2) new drug application for PF708, to be known as Bonsity, in October last year,...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
