Company Product Description Indication Status
Anixa Biosciences Inc., of San Jose, Calif. Prophylactic breast cancer vaccine Prophylactic breast cancer vaccine Breast cancer Filed an IND with the FDA to begin phase I testing
Arca Biopharma Inc., of Westminster, Colo. AB-201 Selective inhibitor of tissue factor  COVID-19 FDA granted fast track designation
Ascentage Pharma Group International, of Suzhou, China APG-2575 Bcl-2 inhibitor Waldenström macroglobulinemia China’s NMPA cleared phase Ib/II trial testing drug as single agent or in combination with ibrutinib/rituximab
Ascentage Pharma Group International, of Suzhou, China APG-2575 Bcl-2 inhibitor Multiple myeloma China’s NMPA cleared start of phase Ib/II trial testing drug as single agent or in combination with lenalidomide/dexamethasone 
Brainever SAS, of Paris BREN-02 Recombinant human homeoprotein Engrailed 1 Amyotrophic lateral sclerosis FDA granted orphan designation
Eiger Biopharmaceuticals Inc., of Palo Alto, Calif. Zokinvy (lonafarnib) Blocks the farnesylation of progerin Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies Approved by FDA; agency also issued rare pediatric disease priority review voucher
Eli Lilly and Co., of Indianapolis Bamlanivimab (LY-CoV555) Antibody COVID-19 Health Canada granted authorization under Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for use as a treatment for adults and pediatric patients 12 or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization
Genentech, of South San Francisco, part of the Roche Group Xofluza (baloxavir marboxil) Endonuclease inhibitor Influenza FDA expanded approved indication to include post-exposure prevention of flu in patients 12 and older after contact with an individual who has the flu
Hillstream Biopharma Inc., of Bridgewater, N.J. HSB-888 Cancer stem cell inhibitor Osteosarcoma FDA granted rare pediatric disease and orphan drug designations
Innovent Biologics Inc., of San Francisco, and Suzhou, China Sulinno (adalimumab biosimilar) Anti-TNF-alpha monoclonal antibody Polyarticular juvenile idiopathic arthritis Approved by China’s NMPA
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda Rilonacept Recombinant dimeric fusion protein blocking interleukin-2-alpha and interleukin-1-beta signaling Recurrent pericarditis FDA accepted supplemental BLA and granted priority review; PDUFA date of March 21, 2021
Merck & Co. Inc., of Kenilworth, N.J. V-114 15-valent pneumococcal conjugate vaccine Pneumococcal disease Submitted applications to FDA and EMA seeking approval for use in adults 18 and older
Neurelis Inc., of San Diego NRL-4 Nasal formulation; unspecified drug target Acute agitation  Concluded pre-IND meeting with FDA
Onconova Therapeutics Inc., of Newtown, Pa. ON-123300 Multikinase inhibitor Relapsed/refractory advanced cancer Filed IND with FDA to start phase I trial to include patients with HR+/HER2-negative metastatic breast cancer with resistance to approved second-generation CDK4/6 inhibitors
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany BNT-162b2 Vaccine COVID-19 FDA scheduled meeting of Vaccines and Related Biological Products Advisory Committee on Dec. 10, 2020, to discuss the request for emergency use authorization
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. REGN-CoV2 (casirivimab and imdevimab) COVID-19 Spike glycoprotein inhibitor COVID-19 FDA issued emergency use authorization for combination to treat mild to moderate COVID-19 in adults and pediatric patients 12 and older weighing at least 40 kg, with positive results of direct SARS-CoV-2 viral testing and who are at high risk of progressing to severe COVID-19
Rigel Pharmaceuticals Inc., of South San Francisco, and Medison Pharma Ltd., of Petach Tikva, Israel Tavalisse (fostamatinib disodium hexahydrate) Syk tyrosine kinase inhibitor Thrombocytopenia Approved by Health Canada for use in adults with chronic immune thrombocytopenia who have had insufficient response to other treatments
Sanofi SA, of Paris Menquadfi (quadrivalent meningococcal tetanus toxoid conjugate vaccine) Protein subunit vaccine Invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y Approved by European Commission for active immunization of individuals from the age of 12 months and older
Theralase Technologies Inc., of Toronto Theralase Photodynamic therapy BCG-unresponsive non-muscle invasive bladder cancer FDA granted fast track designation for phase II study
VBI Vaccines Inc., of Cambridge, Mass. 3-antigen prophylactic hepatitis B vaccine 3-antigen prophylactic hepatitis B vaccine Prevention of hepatitis B virus Submitted MAA to EMA seeking approval for prevention of infection caused by all known subtypes of HBV in adults

Notes

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