Does being an orphan speed up FDA approval?

Despite missing the primary endpoint, SB-01 demonstrated durable clinical improvements and consistent results in the Phase III MODEL trial (NCT05516992), reinforcing its potential as a non-surgical treatment for chronic low back pain associated with degenerative disc disease.

LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.

Following the discontinuation of ALLO-647 due to a treatment-related death, Allogene will move forward with a streamlined outpatient regimen aimed at accelerating enrollment and regulatory review in the Phase II ALPHA3 trial (NCT06500273).

Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.

Gene Mack, CEO, GAIN Therapeutics, outlines how early trial results for GT-02287 are shaping the company’s strategy for advancing a potential new treatment for Parkinson’s disease.

Computational chemistry combined with AI technologies has become a powerful tool for assessing small molecule properties, high-resolution protein structures, and molecular mechanism of action, as well as optimizing target selection and small molecule design.