Phase II
The FDA rejected Gilead’s New Drug Application, citing Chemistry Manufacturing and Controls (CMC) problems associated with the compatibility of the drug with the proposed container vial.
The FDA declined approval for Amryt Pharma’s therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.
The FDA lifts its clinical hold on Ocugen’s COVID-19 vaccine, and Ocugen announces a clinical trial for the treatment of inherited retinal diseases.
The company is conducting analyses to understand safety data that had been gathered prior to the pausing of the three studies, NCT04605159, NCT04980391 and NCT05229068.
With nipocalimab, Janssen is hoping to take one big swing and knock the power right out of these autoantibodies.
The FDA places holds, companies receive clearance for new studies and Pharma giants release new data in last week’s clinical trial news.
Biopharma companies are continuously working to test new treatments to the market. Here are three clinical updates announced this week, spanning three different continents.
Adagio Therapeutics has appointed current COO David Hering as interim CEO, replacing Tillman Gerngross, Ph.D., who communicated his intention to resign in mid-February.
Studies of Relmada’s drug, esmethadone, showed the drug had lower human abuse potential when compared to ketamine. Here are the results of this study.
AstraZeneca and Sanofi secured accelerated authorization for respiratory syncytial virus (RSV) antibody nirsevimab from the European Medicines Agency.
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