FDA, Industry Taking Steps to Streamline Cell Therapy Regulation, Though Uncertainty Remains
At two recent meetings, representatives from regulatory agencies, industry, and academia discussed ways to foster efficient, more predictable cell therapy regulation.
While patients can benefit greatly from non-trial access to investigational therapies, policy experts are calling for more guardrails around those programs.
Gilead Sciences Acquires XinThera, Adds PARP1 Inhibitors to Oncology Pipeline
The acquisition will bring several oncology assets into Gilead's pipeline, including a PARP1 inhibitor that may enter clinical trials later this year.
Bristol Myers Squibb's Breyanzi Nets Second-Line Lymphoma Approval in Europe
The European Commission approved the autologous CAR T-cell therapy for relapsed lymphoma patients following first-line chemo-immunotherapy.
Gilead Q1 Oncology Segment Sales Jump 59 Percent
Trodelvy sales increased 52 percent, Yescarta sales grew 70 percent, and Tecartus revenues increased 40 percent in Q1 2023 compared to the year-ago quarter.