US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back although the companies stress no CRL has been issued.
The US FDA has had to delay the possible marketing approval of Hanmi Pharmaceutical Co., Ltd. and Spectrum Pharmaceuticals Inc.’s novel long-acting neutropenia drug Rolontis (eflapegrastim) because of the impact of the COVID-19 pandemic on its ability to conduct plant inspections.
While there will be a potential commercial impact from the postponement of a potential launch, the companies said they would...
While Korean biopharma companies’ out-licensing deals have remained lackluster in the past couple of years, activity around emerging modalities, led by ADCs, have been increasing in line with global trends.
As investor sentiment around Korean biopharma IPOs and financings remained tepid in the second quarter, companies turned to other ways of raising money, including rights offerings. But there are signs of recovery and upcoming catalysts, while on the M&A front Boryung divested a vaccine subsidiary to a private equity consortium.
As it reported mixed second-quarter earnings, South Korea's pharma industry is increasingly turning to obesity pipeline assets. Meanwhile, leadership disputes among family members within Hanmi are resurfacing.
A novel stem cell therapy for Parkinson’s disease developed by a Korean firm has shown what Citeline analysts describe as "very promising" early clinical results at a low dose after one year.
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.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
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.
