Novartis Plans Additional Data on Manufacturing Issues for Mycograb
Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.
Basel, Switzerland (Nov. 17) -Novartis (www.novartis.com) plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (London, www.emea.eu.int) on manufacturing issues to support the approval of its antifungal drug “Mycograb.” The CHMP issued a negative recommendation for the drug.
The submission for European Union approval was made in 2005 by the UK biopharmaceutical company NeuTec Pharma, which Novartis acquired earlier this year. At the time of the acquisition, Novartis said that submission for marketing authorization for Mycograb in the United States was planned for 2009.
In issuing its negative vote, the CHMP concluded that there was insufficient data relating to the manufacturing and characterization of the product to determine the safety of the compound. Mycograb is a recombinant antibody fragment. It is produced through microbial fermentation and by third-party manufacturers.
Novartis is working with these manufacturers and the CHMP to provide further clarification and analysis.
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
