News | January 12, 2022
Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
This surpasses the number of approvals supported in 2020
This surpasses the number of approvals supported in 2020
Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
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In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
MJ will be paid a one-time lumpsum licence fee of Rs 15 crore
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The panel concurred that these supplements resolved post-Covid-19 fatigue and muscle weakness
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