Phase III
The Phase III study showed that ELGN-GI not only improved gastrointestinal (GI) function, but it also reduced life-threatening complications.
After Karyopharm submitted Phase III data from its SIENDO study on Selinexor, the FDA said that it is unlikely to support an sNDA approval for the drug.
FibroGen is tangled up in a Securities Class Action Litigation and Derivative Litigation concerning clinical trial data for its drug Roxadustat.
First Moscow State Medical University has paused recruiting new patients for its ongoing clinical trials following a disruption in the university’s ability to receive clinical trial samples.
The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.
The study, which has yet to be peer-reviewed, found the Pfizer-BioNTech vaccine was only about 12% effective for children ages 5 to 11 years against the Omicron variant.
On Sunday, Boehringer Ingelheim tweeted a message of support for Ukraine, and announced it was standing in solidarity with the embattled Eastern-European country.
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.
Pfizer’s Clostridioides difficile infection vaccine failed to hit the mark, BMS announced priority review for Opdivo in resectable Non-Small Cell Lung Cancer, and Saol enlists help from GeneDx.
In 2021, Sanofi earned about $4.2 billion from Dupixent sales, and Regeneron earned about $1.8 billion.
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