European Commission grants market authorisation for BioMarin’s Voxzogo
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The company has to approach the DCGI for approval to commence the trials
The clinical research organisation located in Hyderabad is a USFDA inspected facility
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
First results demonstrate favourable tolerability of TQL-1055 at all dose levels
The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services
The co-investment of CHF 4 million will result in capacity expansion and support the market introduction of the customer's lead compound
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