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