Therapeutic Innovation & Regulatory Science: An Increasingly Global Approach

The simplified requirements for Camzyos are expected to ease prior contraindications, thereby simplifying treatment and expanding eligibility in patients with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy.

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.

Teigen’s son was diagnosed with type 1 diabetes, inspiring her to promote the importance of early testing.

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.

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade.

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion.