Amneal launches Crexont (carbidopa and levodopa) extended-release capsules for treatment of Parkinson’s disease
- Amneal Pharmaceuticals has launched Crexont, a novel extended-release formulation of carbidopa and levodopa for Parkinson’s disease.
- Crexont combines immediate-release granules and extended-release pellets, offering longer 'Good On' time with less frequent dosing.
- The product is now available at U.S. pharmacies, with samples and sales representative appointments starting on Sept. 23, 2024.
- Eligible patients may benefit from the Crexont Savings Program and the Amneal Patient Assistance Program.
Read more
Lilly's Kisunla approved in Japan for early symptomatic Alzheimer's disease
- The Ministry of Health, Labour and Welfare Japan approved Kisunla (donanemab-azbt) for early symptomatic Alzheimer's disease.
- Approval is based on the TRAILBLAZER-ALZ 2 Phase 3 study, which showed significant slowing of cognitive and functional decline.
- Kisunla demonstrated a 35% slowing of decline in less advanced patients and a 22% slowing in the overall population.
- Next steps include ongoing studies in multiple clinical trials, including TRAILBLAZER-ALZ 3, 5, and 6.
Read more
Takeda receives approval for fruzaqla in Japan for the treatment of unresectable advanced or recurrent colorectal cancer
- Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare to market FRUZAQLA (fruquintinib) for advanced or recurrent colorectal cancer.
- The approval is based on the FRESCO-2 trial, a global Phase 3 study that showed significant benefits in overall survival and progression-free survival.
- FRUZAQLA demonstrated a manageable safety profile, with adverse events leading to discontinuation being similar between the treatment and placebo groups.
- FRUZAQLA is now approved in the U.S., European Union, Japan, and several other countries, with plans to expand availability further.
Read more
bluebird bio initiates restructuring to optimize cost structure
- bluebird bio is implementing a restructuring to optimize its cost structure and achieve quarterly cash flow break-even by the second half of 2025.
- The restructuring includes a 20% reduction in cash operating expenses and a 25% reduction in workforce by Q3 2025.
- The company aims to scale to approximately 40 drug product deliveries per quarter and secure additional cash resources.
- Focus will be on the commercial launches of LYFGENIA, ZYNTEGLO, and SKYSONA, with 41 patient starts year-to-date and 40 more anticipated in Q4 2024.
Read more
