UK's Amryt to Open US Clinical Trial Sites for Epidermolysis Bullosa
Amryt (London, UK) , a biopharmaceutical company focused on rare and orphan diseases, today announces that FDA has granted Investigational New Drug (IND) clearance for AP101. This enables the Company to begin opening US clinical trial sites as part of its ongoing global EASE Phase III clinical trial in Epidermolysis Bullosa (EB). EB is a rare genetic skin disorder that can cause skin to blister and tear from the slightest friction or trauma and can, in some cases, cause blistering and erosion of the epithelial lining of internal organs. EB is chronic, potentially disfiguring and life limiting. There are approximately 500,000 people living with EB worldwide and there are currently no approved treatments. AP101 is currently in a Phase III clinical trial (EASE), the largest ever global Phase III study conducted in patients with EB. Trial sites are already open across Europe, Australasia, Latin America and the Middle East and an interim efficacy data readout is due later this year with the top-line data readout expected in Q2 2019. Read Pharm Exec's interview with Amryt CEO, Joe Wiley.
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell 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.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join 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.
Pfizer, GSK Gain ACIP Recommendations for RSV and Meningococcal Vaccines
April 18th 2025The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.
