Phase III
The World Health Organization (WHO) recommends against using Gilead Sciences’ remdesivir as a treatment for COVID-19.
As expected after Pfizer and BioNTech announced their COVID-19 vaccine Phase III trial had completed and demonstrated a 95% efficacy rate, the companies plan to apply for an Emergency Use Authorization (EUA) with the FDA.
Positive top-line data from UniQure’s Phase III HOPE-B gene therapy trial of etranacogene dezaparvove, an investigational AAV5-based gene therapy, point to a potentially curative treatment for patients with moderate to moderately severe hemophilia B.
Topline results from Gilead’s Phase II/III CAPELLA trial show that treatment with the company’s long-acting HIV-1 capsid inhibitor lenacapavir reduces HIV viral load better than placebo in heavily treated patients living with multidrug resistant HIV-1 infection.
In addition to coming sooner than expected, the results are even better than expected. The trial hit all primary efficacy endpoints.
Finerenone is an oral, non-steroidal selective mineralocorticoid receptor antagonist (MRA).
A Phase III trial of NurOwn® (MSC-NTF cells), BrainStorm Cell Therapeutics’ investigational therapy for amyotrophic lateral sclerosis, did not find a statistically significant difference between the therapy and placebo for improving scores on a revised ALS functional rating scale.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 17, 2020.
Only a week after Pfizer and BioNTech’s preliminary data readout of its COVID-19 vaccine suggested a 90% efficacy rate, Moderna reported interim efficacy data for its vaccine of 94.5%.
On Friday, the Boston-based company presented positive Phase III data in progressive familial intrahepatic cholestasis (PFIC) at the American Association for the Study of Liver Diseases’ annual meeting.
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