|Aeon Biopharma Inc., of Newport Beach, Calif.||ABP-450 (prabotulinumtoxinA)||Botulinum toxin complex||Cervical dystonia||FDA accepted IND to begin phase II testing|
|Cytodyn Inc., of Vancouver, Washington||Leronlimab (PRO-140)||CCR5 antagonist||COVID-19||U.K. MHRA requested meeting Sept. 9, 2020, to discuss company’s request for fast track approval to treat patients with mild to moderate symptoms; on the suggestion of the MHRA, Cytodyn will submit its current phase III CD12 study for severe to critical COVID-19 patients in the U.K. to the Urgent Public Health Research scheme to receive possible financial support from the trial sites and government|
|Cytodyn Inc., of Vancouver, Washington||Leronlimab (PRO-140)||CCR5 antagonist||HIV||FDA advised the company it has scheduled a type A meeting Sept. 8, 2020, following receipt of written responses concerning the BLA seeking approval for leronlimab as a combination therapy for highly treatment-experienced HIV patients; agency clarified items it need primarily related to dosage levels|
|Innovent Biologics Inc., of San Francisco||Sulinno (adalimumab)||Biosimilar of Humira||Rheumatoid arthritis, ankylosing spondylitis and psoriasis||National Medical Products Administration of China approved the drug|
|Nippon Shinyaku Co. Ltd., of Kyoto, Japan||Viltepso (viltolarsen)||Morpholino antisense oligonucleotide||Duchenne muscular dystrophy||FDA issued a priority review voucher for the approval of a rare pediatric disease product application|
For more information about individual companies and/or products, see Cortellis.