News | December 07, 2022
Fraunhofer IZI Selects Lonza’s MODA-ES Solution to Digitalize Manufacturing Operations
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
The acquired brands are well established and recognized among doctors and other members of the medical fraternity in Brazil for their reliability, safety, and trustworthiness
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
Subscribe To Our Newsletter & Stay Updated
