Spark's Luxturna is all but guaranteed to reach the US market as the first gene therapy following a unanimous positive FDA advisory committee review. Discussions about cost and value are sure to intensify.
Spark Therapeutics Inc. put together a convincing lineup of patients and advocates to provide testimony urging FDA's Cellular, Tissue and Gene Therapies Advisory Committee to support US FDA approval of Luxturna (voretigene neparvovec) for a rare inherited blindness.
The testimony at the panel's Oct. 12 meeting, largely showcasing Luxturna as a life-altering therapy that gives patients a chance...
Companies stand a better chance of securing public reimbursement in Mexico for innovative medicines if they understand changing approaches to healthcare. The shift means the emergence of managed entry agreements and a focus on economic impact, explains AMIIF, Mexico's research-based pharmaceutical industry association.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
