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
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
The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours
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
It adds Rezurock (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD)
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The transactions resulted in a net cash inflow of Rs 183 crores for HCG in addition to the take-over of the labs and clinical research business
The trial will be conducted across 10 sites in India
The vaccine is designed to neutralise the virus in the nostril itself and prevent it from penetrating deep down into the respiratory tract
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