Janssen Pharmaceutical Cos.'s Elmiron (pentosan polysulfate) needs generic competition, FDA says.
The orphan drug indicated for relief of bladder pain or discomfort associated with interstitial cystitis was approved in 1996 and...
US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.

Janssen Pharmaceutical Cos.'s Elmiron (pentosan polysulfate) needs generic competition, FDA says.
The orphan drug indicated for relief of bladder pain or discomfort associated with interstitial cystitis was approved in 1996 and...
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.
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.