Clinical research
Alzamend Neuro is looking to commence a Phase II multiple ascending dose study of lead compound, AL001, in Alzheimer’s disease during the second quarter of this year.
The studies are of the U2 combination Ukoniq (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
The FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
The researchers believe Keytruda and possibly other anti-PD-1 checkpoint inhibitors might help the immune system track the last signs of HIV while also preventing HIV’s ability to hide.
In the last two years, the sheer volume of scientific research focused on COVID-19 has been astounding—thousands of clinical studies, dozens of vaccines and new compounds, and hundreds of approved drugs tested for efficacy against COVID-19.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Cortexyme said it plans to provide additional updates pending further talks with the FDA.
Incyte’s decision follows consultation with the FDA, where it decided that it could not support any confirmatory studies that might be required in the future given the limited time frame.
Vaccinex announced positive interim response data in a Phase Ib study assessing pepinemab in combination with Merck’s vaunted checkpoint inhibitor, Keytruda.
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