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Drug & Device Pipeline News
August 30, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Bio-Path Holdings | BP1002 (liposomal Bcl-2) | Refractory/relapsed acute myeloid leukemia | IND approved by the FDA |
| Blade Therapeutics | cudetaxestat | Idiopathic pulmonary fibrosis | IND approved by the FDA |
| Cardiol Therapeutics | CardiolRx | Acute myocarditis | IND approved by the FDA |
| HebaBiz Biotech | siroquine (JP001) | Newly diagnosed glioblastoma | IND approved by the FDA |
| Abivax | ABX464 | Ulcerative colitis | Phase 1 trial authorized by Japan’s regulatory authority |
| Antengene | selinexor (Xpovio) | Myelofibrosis | Phase 2 trial authorized by China’s regulatory authority |
| Inovio | INO-4800 | COVID-19 vaccine | Phase 3 portion of phase 2/3 trial authorized by Brazil’s regulatory authority |
| InDex Pharmaceuticals | cobitolimod | Moderate-to-severe left-side ulcerative colitis | Phase 3 trial authorized by the FDA |
| Trials Initiated | |||
| Camino Pharma | SBP-9330 | Smoking addiction | Initiation of phase 1 trial |
| Claritas Pharmaceuticals | R-107 | COVID-19 and other viral infections | Initiation of phase 1 trial in Australia |
| Sen-Jam Pharmaceutical | SPJ-001 | Prevention of alcohol hangover | Initiation of phase 1 trial |
| Hutchmed | fruquintinib plus tislelizumab | Advanced triple-negative breast cancer or advanced endometrial cancer | Initiation of phase 1b/2 trial |
| Rafael Pharmaceuticals | CPI-613 (devimistat) | Patients with locally advanced unresectable or metastatic biliary tract cancer who have had no prior treatment | Initiation of phase 2 portion of phase 1b/2 trial |
| Ascletis Pharma | ASC42 | Chronic hepatitis B | Initiation of phase 2 trial in China |
| Bavarian Nordic | ABNCoV2 | COVID-19 vaccine | Initiation of phase 2 trial |
| BioSight | aspacytarabine (BST-236) | Relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia | Initiation of phase 2 trial |
| Servier OSE Immunotherapeutics |
OSE-127/S95011 | Sjögren’s syndrome | Initiation of phase 2 trial |
| Arcutis | Topical roflumilast foam | Scalp and body psoriasis | Initiation of phase 3 trial |
| Emergent BioSolutions | SARS-CoV-2 immune globulin intravenous (human) plasma-derived therapy | Outpatient treatment for patients with COVID-19 that are at high risk of progression to severe disease | Initiation of phase 3 trial |
| Approvals | |||
| Boehringer Ingelheim Eli Lilly |
Jardiance (empagliflozin) 10 mg | Adults with heart failure with reduced ejection fraction | Approved by the FDA for expanded indication |
| Bristol Myers Squibb | Opdivo (nivolumab) | Patients with high-risk urothelial carcinoma | Approved by the FDA for expanded indication |
| Janssen Pharmaceuticals | Xarelto (rivaroxaban) vascular dose | Treatment of patients following recent lower-extremity revascularization due to symptomatic peripheral artery disease | Approved by the FDA for expanded indication |
| Pfizer-BioNTech | Comirnaty COVID-19 vaccine | COVID-19 prevention | Full approval granted by the FDA |
| Servier | Tibsovo (ivosidenib) tablets | Treatment of patients with previously treated IDH1-mutated cholangiocarcinoma | Approved by the FDA for expanded indication |
| Vifor Cara Therapeutics |
Korsuva (difelikefalin) for injection | Moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis | Approved by the FDA |
| Medtronic | Evolut FX TAVR system | Symptomatic severe aortic stenosis | Approved by the FDA |
| Vivos Therapeutics | Modified mandibular repositioning nighttime appliance | Obstructive sleep apnea | Approved by the FDA |
| Xeris Pharmaceuticals | Gvoke kit | Severe hypoglycemia in patients age two years and older with diabetes | Approved by the FDA for expanded indication |
| Argenx | efgartigimod | Generalized myasthenia gravis | Approved in the European Union |
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