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...
Despite new challenges related to obesity drug insurance coverage in the US, MetaVia's CEO is confident in the company's novel contender, which unlike rival GLP-1 therapies doesn’t require dose titration.
South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.
AI-powered drug development was a major topic at the recent Bio Korea meeting, where experts discussed how the technology is changing R&D activities and the challenges being faced by Korean firms as they look to catch up with their global competitors.
Biosimilars giant Celltrion tells shareholders there could be multiple opportunities for its business under US President Donald Trump’s latest executive order on drug pricing.
LTZ Therapeutics and Beijing Sungen Biomedical are among the Chinese biotechs raising new funding, of around $40m each, based on their clinical assets with novel mechanisms of action. While fundings have risen, they remain moderate however.
IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?
Pursuing first-in-class molecular glue degraders using undruggable targets could eventually help Degron Therapeutics land sizable asset-based deals, CEO Lily Zou tells Scrip.
