Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market
NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections
Longest survival follow-up ever reported for immunotherapy treatment in this setting
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
The demand in Africa for COVID-19 vaccines has declined
IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide
The offer price corresponds to a premium of 142% on the volume-weighted average price during the last three months
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This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
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