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Latest From CV Therapeutics, Inc.
Deal Watch: Sol-Gel To Tackle Gorlin Syndrome In Pact With BridgeBio’s PellePharm
Shoreline picks up technology platform rights and access from Editas, which recently reduced staff. Hyloris out-licenses commercial rights to Maxigesic in nine EU markets to Salus.
Dong-A ST Achieves Therapeutic Equivalence With Stelara Biosimilar
Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.
Generics And Biosimilars Industry Reshaped By Transformations
The latest Generics Bulletin Top 50 ranking of global generics and biosimilars companies sees a new name in the top five amid transformations for some of the leading off-patent players. Meanwhile, a number of mid-level firms shift position and newcomers climb into the bottom of the table.
US FDA’s Non-Cancer Accelerated Approval Drugs Get Their Own Public Databases
Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.
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