The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO
This approval of shelf-life extension was based on the availability of additional stability data, which was submitted to CDSCO
Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
Filing marks first protein-based vaccine submitted to MHRA for authorization
Key takeaways of recent quarter & conference call highlights
The company proposes to invest up to US $ 50 million, over a period of five years, starting from FY22, to support capability development of talent and technology
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