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Drug & Device Pipeline News
April 24, 2023
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
HanchorBio | HCB101 | Advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma | IND for a phase 1 trial approved by the FDA |
Sensei Biotherapeutics | SNS-101 | Solid tumors | IND for a phase 1/2 trial approved by the FDA |
NS Pharma | NS-089/NCNP-02 | Duchenne muscular dystrophy amenable to exon 44-skipping therapy | IND for a phase 2 trial granted by the FDA |
Zucara Therapeutics | ZT-01 | Nocturnal hypoglycemia in patients with type 1 diabetes | IND for a phase 2 trial approved by the FDA |
APEX Labs |
APEX-90, (macrodose synthetic psilocybin) |
Severe depression within PTSD | No Objection Letter issued by Health Canada for a phase 2b trial |
Minghui Pharmaceutical | MH004 Cream | Mild-to-moderate atopic dermatitis | IND for a phase 3 trial approved by the FDA |
AffaMed Therapeutics | Dextenza | Ocular inflammation and pain following ophthalmic surgery | Phase 3 trial authorized by China’s regulatory authority |
Trials Initiated | |||
IDEAYA Biosciences | IDE161 | HRD+ solid tumors | Initiation of a phase 1 trial |
Leyden Laboratories | CR9114 intranasal PanFlu antibody | Influenza pandemic | Initiation of a phase 1 trial |
Perception Neurosciences | PCN-101 (R-ketamine) | Treatment-resistant depression | Initiation of a phase 1 trial |
Totus Medicines | TOS-358 | PIK3CA mutated solid tumors | Initiation of a phase 1 trial |
XBiotech | Hutrukin | Brain injury following ischemic stroke | Initiation of a phase 1 trial |
Amylyx Pharmaceuticals | AMX0035 (sodium phenylbutyrate and taurursodiol) | Wolfram syndrome | Initiation of a phase 2 trial |
Kiora Pharmaceuticals | KIO-101 | Ocular presentations of autoimmune diseases | Initiation of a phase 2 trial |
Technoderma Medicines | TDM-105795 | Androgenetic alopecia | Initiation of a phase 2 trial |
Longeveron | Lomecel-B | Aging-related frailty | Initiation of a phase 2 trial in Japan |
Cantex Pharmaceuticals | Azeliragon | Patients hospitalized for COVID-19 | Initiation of a phase 2/3 trial |
Cali Biosciences | CPL-01 (long-acting ropivacaine) | Hernia pain | Initiation of a phase 3 trial |
RegeneRx Biopharmaceuticals | RGN-259 | Neurotrophic keratitis | Initiation of a phase 3 trial |
Renovion | ARINA-1 | Bronchiolitis obliterans syndrome lung transplant patients | Initiation of a phase 3 trial |
Approvals | |||
Gamida Cell | Omisirge (omidubicel-onlv) | Allogeneic stem cell transplant therapy for use in patients older than age 12 years with hematologic malignancies | Approved by the FDA |
AbbVie | Qulipta (atogepant) | Chronic migraine | Approved by the FDA for expanded indication |
Genentech | Polivy in combination with R-CHP | First-line treatment of diffuse large B-cell lymphoma | Approved by the FDA for expanded indication |
AbbVie | Rinvoq (upadacitinib | Crohn's disease | Approved by the European Commission |
Innocare Pharma | Orelabrutinib | Relapsed/refractory marginal zone lymphoma | Approved in China |
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