Phase III
Late Friday, the regulatory agency rejected the medication of sutimlimab due to deficiencies from a pre-license inspection of a third-party manufacturing facility.
It was a particularly busy week for clinical trial updates, mostly because of several virtual conferences, including the virtual American Heart Association Scientific Sessions 2020 and The Society for Immunotherapy of Cancer’s Annual Meetings. Here’s a look.
Pfizer announced today that it has received positive top-line results from the Phase III JADE REGIMEN study, examining abrocitinib for the treatment of severe atopic dermatitis.
Here’s a look at recent clinical trial pauses around the biopharma industry.
Merck and Eisai announced today that they have new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307).
Amgen and AstraZeneca announced that their Phase III NAVIGATOR trial of Tezepelumab hit the primary endpoint in severe asthma.
Talaris Chief Executive Officer Scott Requadt sees FCR001, the company’s investigational cell therapy, as a potential pipeline in a product (an experimental treatment that could have multiple uses across a number of indications).
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 10, 2020.
Calliditas said Nefecon hit its primary endpoint by demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after nine months of treatment.
They caution that as more data is accumulated and analyzed, the efficacy percentage may shift. Nonetheless, it’s extremely promising and there were no serious safety signals.
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