Company Product Description Indication Status

Biovie Inc., of Santa Monica, Calif.

BIV-201

Continuous infusion terlipressin

Ascites due to chronic liver cirrhosis

Submitted protocol for phase IIb/III study to the FDA; trial to test drug in patients who are refractory to or cannot tolerate diuretic therapy

Bluewillow Biologics Inc., of Ann Arbor, Mich.

BW-1010

Intranasal anthrax vaccine

Anthrax

FDA cleared the IND for a phase I study, set to start enrollment this year; funded by National Institute of Allergy and Infectious Diseases

Janssen Pharmaceutical Cos., of Beerse, Belgium, part of Johnson & Johnson

Tremfya (guselkumab)

Human monoclonal antibody against p19 subunit of IL-23

Active psoriatic arthritis

Submitted type II variation application to the EMA seeking first-in-class approval

Moderna Inc., of Cambridge, Mass.

mRNA-3927

2 mRNAs encoding for alpha and beta subunits of mitochondrial enzyme propionyl-CoA carboxylase, encapsulated on lipid nanoparticle

Propionic acidemia

FDA granted fast track designation

Notes

For more information about individual companies and/or products, see Cortellis.

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