The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories
Dr Reddy’s will pay Immutep US$ 20 million upfront and could deliver as much as US$ 349.5 million in regulatory and commercial milestones
The partnership also allows both companies to explore CR-001 and SKB105 as monotherapies and in combination
Takeda will pay Innovent US$1.2 billion upfront, including a US$100 million equity investment in Innovent
Valorum will advance the commercialization and distribution of Armlupeg in the United States
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