Biogen pushes ahead with approval submission in potentially large Japanese market, despite the negative views of a recent advisory committee in the US.
Apparently undeterred by a major potential setback for the drug in the US, Biogen, Inc. has made a submission in Japan for the marketing approval of aducanumab, the amyloid beta-targeting antibody it is developing globally with Japan-based Eisai Co., Ltd.
The new filing, lodged with the Ministry of Health, Labour and Welfare, adds a third regulatory review to those already...
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.
Several major Japanese firms, including Takeda, are planning layoffs at home and elsewhere as they make efforts to streamline their business and costs and cope with R&D and commercial challenges.
Results from the top Japanese pharma firms in the fiscal first quarter were marked mainly by strong global performances for mainstay products and significant currency effects due to the continued weakness of the yen, although forex concerns are rising. Eisai's Alzheimer's drug Leqembi also gained momentum, particularly in the US.
Otsuka Pharma’s acquisition of Jnana seems like a win for its pipeline, but the Japanese major faced a setback in a Delaware District Court where the judge’s opinion put challenger Lupin closer to a generic to its Jynarque (tolvaptan)
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.
