5 documents

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20:40 , Feb 3, 2017 |  BC Week In Review  |  Clinical News

Zioxtenzo regulatory update

EMA's CHMP said Novartis withdrew its MAA for Zioxtenzo, its biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.). Pegfilgrastim is a pegylated G-CSF. Last year, FDA issued a complete response...
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07:00 , Jul 18, 2016 |  BC Week In Review  |  Clinical News

CHS-1701: Phase I data

Top-line data from a single-blind, crossover, U.S. Phase I trial in 122 healthy volunteers showed that a single dose of 6 mg subcutaneous CHS-1701 met the co-primary endpoints of pharmacokinetic and pharmacodynamic bioequivalence compared to...
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08:00 , Feb 8, 2016 |  BC Week In Review  |  Clinical News

CHS-1701: Phase I data

Coherus said a double-blind, U.S. Phase I trial in 303 healthy volunteers showed that 2 sequential subcutaneous doses of 6 mg CHS-1701 met the co-primary endpoints based on the development of neutralizing antibodies and the...
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07:00 , Oct 12, 2015 |  BC Week In Review  |  Clinical News

CHS-1701: Phase I data

Top-line data from a double-blind, crossover, U.S. Phase I trial in 116 healthy volunteers showed that a single subcutaneous injection of 6 mg CHS-1701 met the primary endpoint of biosimilarity to Neulasta pegfilgrastim as...
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02:27 , Dec 18, 2014 |  BC Extra  |  Company News

FDA will review Apotex's Neulasta biosimilar

Apotex Inc. (Toronto, Ontario) said FDA accepted for filing a regulatory application for a biosimilar of pegfilgrastim. The application was submitted under the 351(k) abbreviated approval pathway under the Biosimilar Price Competition and Innovation Act...
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