The facility will supply clinical trial materials for the development of vaccines and biologics up to Phase II stage and is expected to be fully operational by early 2023.
Oravax's vaccine technology is highly scalable for manufacturing and is easily transferable for wide scale logistical distribution, as there is no need for freezer storage
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
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
Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
The company claims to be a market leader in core orthopaedic and gynaecology segments like bone and joint disorders, pain management and, pregnancy and women’s nutrition
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients
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