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
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
Gland Pharma enters into a Put Option Agreement to acquire 100% of Cenexi Group
Steve joins Sai Life Sciences from GlaxoSmithKline (GSK) where he was a department head and member of the global chemical development leadership team.
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
Under the terms of this agreement Biocon will be responsible for the manufacturing and supply of Liraglutide to Zentiva, for its commercialization across 30 countries in Europe
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
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