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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

April 11, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
Shanghai Junshi Biosciences TAB009/JS009 Advanced solid tumors IND approved by the FDA
Starton Therapeutics STAR-OLZ Chemotherapy-induced nausea and vomiting IND approved by the FDA
Tonix Pharmaceuticals TNX-102 SL Long COVID IND approved by the FDA
ValenzaBio VB421 Thyroid eye disease IND approved by the FDA
Sorrento Therapeutics Abivertinib Severe pneumonia in hospitalized patients due to COVID-19 Approval for a phase 2/3 trial granted by the FDA
Fractyl Health Revita DMR system Type 2 diabetes patients who are not yet on insulin IDE approved by the FDA
Accutar Biotechnology AC0682 ER+ breast cancer IND approved by China’s regulatory authority
Ascletis Pharma ASC60 Advanced solid tumors IND approved by China’s regulatory authority
Claritas Pharmaceuticals R-107 Pulmonary arterial hypertension Approval for a phase 1 trial granted by Australia’s regulatory authority
Trials Initiated
Athira Pharma ATH-1020 Neuropsychiatric conditions Initiation of phase 1 trial
Bond Biosciences BBI-001 Hemochromatosis Initiation of phase 1 trial
NGM Bio NGM831 Advanced solid tumors Initiation of phase 1 trial
Nurix Therapeutics DeTIL-0255 Advanced gynecological malignancies Initiation of phase 1 trial
Sirnaomics STP707 Liver fibrosis in primary sclerosing cholangitis Initiation of phase 1 trial
Zhimeng Biopharma CB06 Chronic hepatitis B virus infection Initiation of phase 1 trial
PepGen PGN-EDO51 Duchenne muscular dystrophy Initiation of phase 1 trial in Canada
4D Molecular Therapeutics 4D-710 Cystic fibrosis Initiation of phase 1/2 trial
Genprex Reqorsa plus Keytruda Nonsmall-cell lung cancer Initiation of phase 1/2 trial
Ocugen OCU400 Retinitis pigmentosa Initiation of phase 1/2 trial
Processa Pharmaceuticals PCS12852 Gastroparesis Initiation of phase 2a trial
Altimmune Pemvidutide Obesity Initiation of phase 2 trial
Lakewood-Amedex Bisphosphocin Nu-3 Chronic diabetic foot ulcers Initiation of phase 2 trial
Meiji Seika Pharma ME3183 Plaque psoriasis Initiation of phase 2 trial
NewAmsterdam Pharma Obicetrapib in combination with ezetimibe High levels of low-density lipoprotein cholesterol Initiation of phase 2 trial
Verrica Pharmaceuticals LTX-315 Basal cell carcinoma Initiation of phase 2 trial
Respira Therapeutics RT234 Pulmonary arterial hypertension Initiation of phase 2b trial
Tonix Pharmaceuticals TNX-102 SL Fibromyalgia Initiation of phase 3 trial
Approvals
BioXcel Therapeutics Igalmi (dexmedetomidine) sublingual film Agitation associated with schizophrenia or bipolar disorder in adults Approved by the FDA
Kite Therapeutics Yescarta (axicabtagene ciloleucel) Relapsed or refractory large B-cell lymphoma Approved by the FDA for expanded indication
Nobelpharma America Hyftor (sirolimus topical gel) Facial angiofibroma associated with tuberous sclerosis complex Approved by the FDA
Novartis Vijoice (alpelisib) PIK3CA-related overgrowth spectrum Approved by the FDA
Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Certain forms of relapsed or refractory large B-cell lymphoma Approved by the European Commission
Bristol Myers Squibb Opdivo (nivolumab) Adjuvant treatment of muscle-invasive urothelial carcinoma patients at high risk of recurrence after undergoing radical resection Approved by the European Commission for expanded indication
Bristol Myers Squibb Opdivo (nivolumab) plus Yervoy (ipilimumab) Esophageal squamous cell carcinoma Approved by the European Commission for expanded indication
Immunocore Kimmtrak (tebentafusp) Unresectable or metastatic uveal melanoma Approved by the European Commission
Sanofi Dupixent (dupilumab) Severe asthma with type 2 inflammation in children age 6 to 11 years Approved by the European Commission for expanded indication

 

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