Why is there still a lack of diversity in clinical trials? Shelli Pavone: Unfortunately equity and healthcare have ...

The regulatory landscape for CAR T-cell therapies is constantly evolving with the FDA establishing their own guidelines needed for approval. Often, the approval can be long and difficult to obtain.

Approval was based on results from the Phase III CheckMate-67T trial, which demonstrated non-inferior pharmacokinetics compared to intravenous Opvido. The FDA has approved Bristol Myers Squibb’s (BMS) ...

Regulatory agencies are open to changes within the review process which means the uptake of CAR T-cell therapy will change the landscape itself. This is especially true with large-scale ...

The panelists provide their closing thoughts on CAR T-cell therapies and what they look forward to as these therapies become popular beyond cancer, extending to autoimmune diseases as well. There is ...

Site selection for CAR T-cell clinical trials is a complex process that requires the right expertise, capability, and facility. Infrastructure is another major factor to consider as patients will ...

Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 ...

Jennifer Hawks Bland, CEO of NewYorkBIO, shares her journey from litigation to biotech leadership, discusses fostering innovation in New York's thriving bioscience ecosystem, and outlines her vision ...

Under terms of the deal, Johnson & Johnson will gain an exclusive license to the STAT6 program, with Kaken maintaining commercialization rights in Japan. Johnson & Johnson (J&J) announced that it has ...

Clinical trials involve a lot of moving parts which require a good relationship between a sponsor, CRO, and site. Having logistical and study coordinators are one tool to better ensure everything is ...

For the past two years, Ozempic and Wegovy have dominated the conversation when it comes to weight-loss medications (WLMs). The two medications, developed and distributed by Novo Nordisk, have made ...

Panelists set up for addressing the clinical trial landscape, key challenges, regulations, and the future of cell and gene therapy. In this exclusive Pharmaceutical Executive Roundtable video series, ...