Biotech | October 27, 2021
Novavax files for approval of its Covid-19 vaccine in the UK
Filing marks first protein-based vaccine submitted to MHRA for authorization
Filing marks first protein-based vaccine submitted to MHRA for authorization
The collaboration aims to deliver greater insights to the oncology fraternity, predict patient therapy responses and enable therapy selection resulting in optimal treatment outcomes.
The company’s wide therapeutic portfolio helped to sustain growth despite changing market demand
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The revised deal involves a cash consideration only as against the earlier proposal of cash and equity
The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan
Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
CuraTeQ Biologics is on track for filing a second oncology biosimilar
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