SPOTLIGHT -
In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.
Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.
FDA Accepts Eisai, Biogen’s Biologics License Application for Subcutaneous Leqembi in Early Alzheimer Disease
Acceptance of the Biologics License Application for subcutaneous Leqembi is based on results from the Clarity AD open-label extension and modeling of observed data in patients with Alzheimer disease.
FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Generalized Myasthenia Gravis
Priority Review was based on results from the Phase III Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.
FDA Mandates Updates to Prescribing Information for RSV Vaccines Abrysvo, Arexvy for Increased Guillain-Barré Syndrome Risk
Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barré Syndrome.
FDA Grants Fast Track Designation to Vergent Bioscience’s Novel Agent for Visualizing Solid Tumors During Lung Cancer Surgeries
Fast Track designation was based on results from a Phase II study, which demonstrated that VGT-309 was safe, well-tolerated, and enhanced tumor visualization in lung cancer patients.
FDA Grants Breakthrough Therapy Designation to GSK’s Novel Treatment for Relapsed or Refractory Osteosarcoma
Breakthrough Therapy Designation for GSK5764227 was based on data from the ARTEMIS-002 Phase II trial, which demonstrated promising efficacy and safety in 42 osteosarcoma patients.