The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response, has awarded Vir Biotechnology Inc. approximately $50 million in new funding to advance the development of novel monoclonal antibody (MAb) candidates and delivery solutions to widen the applicability of MAbs in COVID-19 and in pandemic preparedness and response.

The FDA has cleared an IND application for ADEL-Y01, being jointly developed by Oscotec Inc. and Adel Inc., for the treatment of Alzheimer’s disease. A phase Ia/b study will include healthy volunteers, and participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.

Biomarin Pharmaceutical Inc. has reported progress across its research and development portfolio, including early-stage product candidates.

Antoxa Corp. and Swiftpharma BV have signed an exclusive collaboration agreement to support the development and commercialization of a plant-made monoclonal antibody against ricin exposure.

Most of the West African population is at risk of infection with Lassa virus (LASV), which leads to Lassa fever that causes thousands of deaths every...

Canariabio Inc.'s MAb-AR20.5 has been awarded orphan drug designation by the FDA for pancreatic cancer. MAb-AR20.5 is an IgG1k type murine monoclonal antibody that binds specifically to the circulating and tumor-associated antigen (MUC1) expressed on pancreatic cancer cells.

Zumutor Biologics Inc. has received FDA clearance of its IND application for ZM-008 to enter a first-in-human phase I study for the treatment of multiple solid cancers. A phase I study is anticipated to begin in the fourth quarter, and will include evaluation of ZM-008 followed by pembrolizumab.

Cessation Therapeutics Inc. has obtained IND clearance from the FDA to initiate a first-in-human trial of CSX-1004 for the prevention of fentanyl overdose. The trial in healthy volunteers is expected to begin next month.