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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

November 1, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
Precigen PRGN-3007 ROR1+ hematological and solid tumors IND approved by the FDA
Bio-Path Prexigebersen-A Solid tumors IND approved by the FDA for a phase 1/1b trial
Angel Pharmaceuticals CPI-818 Relapsed/refractory T-cell lymphoma IND for a phase 1/1b trial approved by China’s regulatory authority
Medicenna MDNA11 Advanced, relapsed or refractory solid tumors IND for expansion of a phase 1/2 trial approved by the FDA
TFF Pharmaceuticals Inhaled formulation of Niclosamide COVID-19 Phase 1 trial approved by Canada’s regulatory authority
HCW Biologics HCW9218 Advanced pancreatic cancer Phase 1b trial approved by the FDA
Huyabio International HBI-2376 KRAS and EGFR mutated tumors IND for a phase 1 trial approved by the FDA
BioVie NE3107 Parkinson’s disease Phase 2 trial approved by the FDA
Vitti Labs Umbilical cord mesenchymal stem cells in combination with umbilical cord mesenchymal stem cell exosomes Acute respiratory distress syndrome associated with the COVID-19 IND for a phase 2 trial approved by the FDA
Axial Therapeutics AB-2004 Irritability associated with autism spectrum disorder IND for a phase 2b trial approved by the FDA
Trials Initiated
Cleveland Clinic

Anixa Biosciences
Breast cancer vaccine Early-stage triple-negative breast cancer Initiation of a phase 1 trial
Akeso AK127 + Cadonilimab Advanced or metastatic solid tumors Initiation of phase 1 trial in Australia
Dice Therapeutics S011806 Psoriasis Initiation of phase 1 trial
Matinas Biopharma MAT2501 Nontuberculous mycobacterial infection Initiation of phase 1 trial
Sumitomo Dainippon Pharma DSP-0390 Recurrent high-grade glioma Initiation of phase 1 trial
EsoCap ESO-101 Active eosinophilic esophagitis Initiation of phase 2 trial
Gilead

Merck
islatravir and lenacapavir HIV treatment for patients who are virologically suppressed and on antiretroviral therapy Initiation of phase 2 trial
Revolo Biotherapeutics ‘1104 Allergy Initiation of phase 2 trial in the UK
Alkermes nemvaleukin alfa with pembrolizumab Platinum-resistant ovarian cancer Initiation of a phase 3 trial
HutchMed HMPL-523 Primary immune thrombocytopenia Initiation of a phase 3 trial in China
Approvals
Bausch + Lomb

Clearside Biomedical
XIPERE (triamcinolone acetonide injectable suspension) Macular edema associated with uveitis Approved by the FDA
Genentech Susvimo (ranibizumab injection) Patients with wet, or neovascular, age-related macular degeneration who have previously responded to at least two anti- VEGF injections Approved by the FDA
Moderna

Janssen
COVID-19 vaccines Immunization against COVID-19 Booster dose following primary immunization approved by the FDA
Merck Keytruda in combination with chemotherapy First-line treatment of locally recurrent unresectable or metastatic PD-L1-expressing triple-negative breast cancer in adults who have not received prior chemotherapy for metastatic disease Approved by the European Commission

 

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