Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
Construction will begin this year with the new capacity anticipated by 2025
Acuitas Therapeutics' LNP technology will support Bayer’s in vivo gene editing and protein replacement programs with the goal of specifically delivering RNA payloads to the desired target organ, the liver.
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
Records revenue growth of 22% to Rs. 762 crores in Q4 FY23 and grew 30% to Rs. 3149 crores in FY23
The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
The judicial response to industry lawsuits on drug pricing regulations have been mixed in the past
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