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Home » Drug & Device Pipeline News

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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