EMA encourages companies to submit type I variations by end- November
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021
The acquisition expands Takeda’s immuno-oncology and innate immune cell therapy portfolio with novel platforms leveraging T cells for the potential treatment of solid tumours and haematological malignancies
In India, MSD has signed non-exclusive licensing agreements with eight pharma companies.
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
Following the review of around 20 candidate vaccines by the external advisory group, MVC's vaccine was selected as one of two to be included in the global trial
Filing marks first protein-based vaccine submitted to MHRA for authorization
The Research Services and Biosimilars business segments reported a growth of 17% and 10%, respectively
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option
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
Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)
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