The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
Move to increase affordability and accessibility for heart failure patients across the country
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
This product is based on Osmotic Controlled Release Oral Delivery System technology
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
Latest innovations feature vendor-neutral solutions to help reduce clinical complexity and enhance operational efficiency
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
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