In the race to bolster pipelines and drive growth, biopharma manufacturers are reexamining traditional practices and reimagining market research protocols. Biopharma business development and licensing ...

John Hood, CEO, Endeavor BioMedicines discusses a potential timeline on availability of ENV-101 for patients with IPF and further validation of the treatment's safety profile. PE: Given the ...

Data from the Phase III trial program found that AXS-05 demonstrated statistically significant efficacy in treating Alzheimer disease agitation. Axsome Therapeutics announced the successful completion ...

While challenges remain, AI is accelerating the process by enabling researchers to identify and design new drug candidates more quickly and efficiently with applications in target discovery, structure ...

It’s become increasingly clear that a lack of diversity in clinical trials is a major issue for the pharmaceutical industry. While the problem has been identified, the industry is still struggling to ...

The FDA has issued a draft guidance outlining recommendations for the use of artificial intelligence (AI) to support regulatory decisions regarding the safety, efficacy, or quality of drugs and ...

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.

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 ...

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 ...

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 ...

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 ...