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Home » Drug & Device Pipeline News
Drug & Device Pipeline News
October 18, 2021
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Homology Medicines | HMI-103 | Phenylketonuria | IND approved by the FDA |
Landos Biopharma | LABP-104 | Systemic lupus erythematosus | IND approved by the FDA |
Sorrento Therapeutics | resiniferatoxin | Intractable pain associated with advanced cancer | Approval for a phase 2 trial granted by the FDA |
Asieris Pharma | APL-1202 in combination with tislelizumab | Muscle-invasive bladder cancer | IND approved by China’s regulatory authority |
Kintor Pharma | GT90001C and Opdivo (nivolumab) | Advanced hepatocellular carcinoma | Approval for a phase 2 trial granted by China’s regulatory authority |
Arcturus Therapeutics | ARCT-154 STARR mRNA Vaccine | Vaccine targeting SARS-CoV-2 Delta variant | Approval for a phase 3b trial granted by Vietnam’s regulatory authority |
Tonghua Dongbao Pharmaceutical | BioChaperone Lispro | Type 1 and Type 2 diabetes | Approval for a phase 3 trial granted by China’s regulatory authority |
Trials Initiated | |||
TC BioPharm | ImmuniStim, allogeneic gamma-delta T-cell product | COVID-19 | Initiation of phase 1/2 trial in the UK |
VistaGen Therapeutics | PH94B | Anxiety in adults with adjustment disorder and anxiety | Initiation of phase 2a trial |
Faraday Pharmaceuticals | FDY-5301 | ICU-acquired weakness and other muscle-related conditions | Initiation of phase 2 trial |
Oxurion | THR-687 | Diabetic macular edema | Initiation of phase 2 trial |
Union Therapeutics | orismilast oral tablet | Hidradenitis suppurativa | Initiation of phase 2 trial |
Veru Pharma | enobosarm | AR+ER+HER2- metastatic breast cancer | Initiation of phase 3 trial |
Approvals | |||
ChemoCentryx | Tavneos (avacopan) | ANCA-associated vasculitis | Approved by the FDA |
Eli Lilly | Verzenio (abemaciclib) | HR+ HER2-, node-positive, high-risk early breast cancer | Approved by the FDA |
Enzyvant Therapeutics | Rethymic human allogeneic (donor-derived) thymus tissue | Pediatric congenital athymia | Approved by the FDA |
Merck | Keytruda in combination with chemotherapy, with or without bevacizumab | PD-L1+ persistent, recurrent or metastatic cervical cancer | Approved by the FDA for expanded indication |
Ocular Therapeutix | Dextenza (dexamethasone ophthalmic insert) | Ocular itching associated with allergic conjunctivitis | Approved by the FDA for additional indication |
BeiGene | Brukinsa (zanubrutinib) | adults with mantle-cell lymphoma who have received at least one prior therapy | Approved by Australia’s regulatory authority |
Sanofi | Sarclisa (isatuximab for injection) | Relapsed or refractory multiple myeloma | Approved by Canada’s regulatory authority |
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