Covis Pharma
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Latest From Covis Pharma
Oh NOOH! Vanda’s Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz
The notice of opportunity for hearing on the US FDA’s proposal not to approve an insomnia sNDA for Vanda’s Hetlioz opens another front in the company’s aggressive campaign against complete response letters and generic competition to the sleep disorder drug.
EU To Suspend 17-OHPC Preterm Birth Drugs A Year After US Pulled Makena
17-OHPC medicines are to be pulled from the market in Europe due to a potential link with cancer and the lack of efficacy data. The move comes around a year after the US regulator withdrew its approval of a similar drug from Covis.
Accelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules
The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.
Preterm Birth Prevention Studies Need To Look Beyond Makena Endpoints, Experts Say
Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’
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