GlaxoSmithKline/Genmab's anti-CD20 monoclonal antibody Arzerra (ofatumumab) is reasonably likely to have a clinical benefit in heavily pretreated patients with chronic lymphocytic leukaemia (CLL), the US FDA's outside advisors say.
GlaxoSmithKline/Genmab's anti-CD20 monoclonal antibody Arzerra (ofatumumab) is reasonably likely to have a clinical benefit in heavily pretreated patients with chronic lymphocytic leukaemia (CLL), the US FDA's outside advisors say.
In a 10 to three vote, the oncologic drugs advisory committee (ODAC) said objective response rates in a single-arm trial...
The biotech announced positive results in the PIK3CA wild-type population in second-line HR+/HER2- breast cancer for its PAM inhibitor.
With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.
The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.
With $216m in initial funding, the newly launched company is aiming to develop a cell therapy-based universal immuno-oncology option for solid tumor indications.
With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.
The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.
Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.
