Company Product Description Indication Status
Abcellera Biologics Inc., of Vancouver, British Columbia, and Eli Lilly and Co., of Indianapolis Bamlanivimab and etesevimab COVID-19 spike glycoprotein modulator and COVID-19 spike glycoprotein inhibitor COVID-19 EMA’s Committee for Medicinal Products for Human Use issued positive scientific opinion for bamlanivimab alone and bamlanivimab plus etesevimab for use in treating confirmed COVID-19 in patients 12 and older who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19
Biomarin Pharmaceuticals Inc., of San Rafael, Calif. Valoctocogene roxaparvovec Gene therapy Severe hemophilia A FDA granted regenerative medicine advanced therapy designation
Caladrius Biosciences Inc., of Basking Ridge, N.J. CLBS-12 CD34-positive cell therapy Buerger’s disease (thromboangiitis obliterans)  FDA granted orphan designation
Cytodyn Inc., of Vancouver, Wash. Vyrologix (leronlimab, PRO-140) CCR5 antagonist COVID-19 Disclosed pathways for approval, including with U.K. MHRA, which will accept more data from open-label portion of CD12 trial; company initiated process to submit interim order with Health Canada; confirms FDA received protocol for enrolling 140 critically ill COVID-19 patients with primary endpoint defined as length of hospital stay
Gilead Sciences Inc., of Foster City, Calif., and its Kite company Yescarta (axicabtagene ciloleucel) CAR T therapy Relapsed or refractory follicular lymphoma Received accelerated approval from FDA for treating adults after 2 or more lines of systemic therapy
Johnson & Johnson, of New Brunswick, N.J. COVID-19 vaccine Single-dose vaccine COVID-19 Authorized by Health Canada for use in people 18 and older
Junshi Biosciences Co. Ltd., of Shanghai JS-201 PD-1/TGF-β bifunctional fusion protein Cancer China’s NMPA accepted a clinical trial application
Lee’s Pharmaceutical Holdings Ltd., of Hong Kong, its affiliate, China Oncology Focus Ltd., and Sorrento Therapeutics Inc., of San Diego Socazolimab Anti-PD-L1 antibody Extensive-stage small-cell lung cancer Cleared to begin study in China testing first-line treatment; patient recruitment set to start in the second quarter of 2021
Nervgen Pharma Corp., of Vancouver, British Columbia NVG-291 Protein tyrosine phosphatase sigma inhibitor Spinal cord injury EMA granted orphan designation
Passage Bio Inc., of Philadelphia PBGM-01 GLB1 gene stimulator GM1 gangliosidosis FDA granted fast track designation
Passage Bio Inc., of Philadelphia PBFT-02 Adeno-associated virus-based gene therapy expressing granulin Frontotemporal dementia with granulin mutations FDA granted fast track designation
Passage Bio Inc., of Philadelphia PBKR-03 AAV-galactocerebrosidase based gene therapy Krabbe disease FDA granted fast track designation
Roche Group, of Basel, Switzerland, and its Genentech unit Tecentriq (atezolizumab) Anti-PD-L1 antibody Urothelial carcinoma (bladder cancer) Company is voluntarily withdrawing the U.S. indication for prior platinum-treated metastatic disease; decision made in consultation with FDA as part of industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoints and have yet to gain regular approvals
Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 Approved in the Republic of North Macedonia
Saniona AB, of Copenhagen, Denmark Tesomet (tesofensine + metoprolol) Triple monoamine reuptake inhibitor + beta 1 antagonist Hypothalamic obesity Received FDA feedback and proceeding with plans for phase IIb trial in first half of 2021
Sesen Bio Inc., of Cambridge, Mass. Vicineum  Fusion protein High-risk, BCG-unresponsive non-muscle invasive bladder cancer Submitted MAA to EMA under the centralized procedure
Soleno Therapeutics Inc., of Redwood City, Calif. DCCR (diazoxide choline extended-release)  Potassium channel stimulator Prader-Willi syndrome Subsequent to type C meeting with FDA, company submitted additional analyses from phase III Destiny PWS trial, showing significant changes vs. placebo in primary and secondary endpoints; following review, FDA informed Soleno that an additional controlled trial will be necessary to support NDA submission
Steba Biotech SA, of Luxembourg Padeliporfin Impact Vascular-targeted photodynamic therapy  Upper tract urothelial cancer FDA granted orphan designation
Tissuetech Inc., of Miami, and its Amniox Medical Inc. company TTAX-03 Biologic Facet joint pain resulting from osteoarthritis FDA cleared IND for a phase I trial
Ultragenyx Pharmaceutical Inc., of Novato, Calif. UX-053 mRNA therapy Glycogen storage disease type III FDA cleared the IND for a phase I/II study; enrollment set to start in second half of 2021
Vifor Pharma Group, of St. Gallen, Switzerland, and Cara Therapeutics Inc., of Stamford, Conn. Korsuva (difelikefalin)  Opioid receptor kappa agonist Moderate to severe pruritis in hemodialysis patients FDA accepted and granted priority review to NDA; PDUFA date of Aug. 23, 2021; agency said it is not currently planning to hold an advisory committee meeting

Notes

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