Drug Approval | September 12, 2021
US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The company plans to enter the formulation business in January 2022. It has also opened a branch in Hyderabad to trade pharmaceutical chemicals
First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety
HTL will build, validate and operate a botulinum manufacturing facility in the US
Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in the early calendar year 2022
The Bidar API manufacturing facility of Sai Life Sciences has been on a path of significant expansion with its production capacity growing from 200KL in 2017 to 450KL
The revenues and profits derived from the new subsidiary will be consolidated in the parent company
Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data. The global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine
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
The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment
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