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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

December 13, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
Acer Therapeutics ACER-801 (osanetant) Induced vasomotor symptoms IND approved by the FDA
ChemomAb CM-101 Primary sclerosing cholangitis IND approved by the FDA
Cyclo Therapeutics Trappsol Cyclo Early Alzheimer’s disease IND approved by the FDA
MingMed Biotechnology PRJ1-3024 Cancer IND approved by the FDA
Nuvation Bio NUV-422 Advanced breast cancer IND approved by the FDA
Ocugen OCU400 (AAV-NR2E3) Retinitis pigmentosa resulting from genetic mutations in NR2E3 or RHO genes IND approved by the FDA
Biotheus PM8001 Advanced solid tumors Phase 2 trial approved by the FDA
Trials Initiated
Biofrontera Ameluz photodynamic therapy Actinic keratosis Initiation of phase 1 trial
Celldex Therapeutics CDX-0159 Prurigo nodularis Initiation of phase 1 trial
Iterion Therapeutics Tegavivint in combination with osimertinib Metastatic epidermal growth factor receptor-positive nonsmall-cell lung cancer Initiation of phase 1 trial
Tranquis Therapeutics TQS-168 Neurodegenerative disease Initiation of phase 1 trial
Affimed AFM24 in combination with atezolizumab Solid tumors Initiation of phase 1/2 trial
MRM Health MH002 Mild-to-moderate ulcerative colitis Initiation of phase 1b/2a trial
Springworks Therapeutics Nirogacestat Multiple myeloma Initiation of phase 1b/2 trial
Hepagene Therapeutics HPG1860 Nonalcoholic steatohepatitis Initiation of phase 2a trial
Karyopharm Selinexor Myelofibrosis Initiation of phase 2 trial
Ventyx Biosciences VTX002 Moderate-to-severe ulcerative colitis Initiation of phase 2 trial
Vir Biotech

Gilead Sciences
VIR-2218, selgantolimod and nivolumab Chronic hepatitis B virus infection Initiation of phase 2 trial
ZZ Biotech 3K3A-APC Amyotrophic lateral sclerosis Initiation of phase 2 trial
Acurx Pharmaceuticals Ibezapolstat Clostridioides difficile infection Initiation of phase 2b trial
Checkpoint Therapeutics Cosibelimab in combination with chemotherapy First-line treatment of patients with nonsquamous nonsmall-cell lung cancer Initiation of phase 3 trial
DyDo Pharma Firdapse (amifampridine) Lambert-Eaton myasthenic syndrome Initiation of phase 3 trial in Japan
Approvals
Daré Biosciences Xaciato (clindamycin phosphate vaginal gel, 2%) Bacterial vaginosis in females under 12 years of age Approved by the FDA
Eli Lilly

Junshi
Etesevimab (JS016/LY-CoV016) and bamlanivimab (LY-CoV555) Treatment of mild-to-moderate COVID-19 and postexposure prophylaxis in certain high-risk pediatric patients from birth to 12 years of age Emergency Use Authorization expanded by the FDA
Heron Therapeutics Zynrelef (bupivacaine and meloxicam) extended-release solution Soft tissue or periarticular instillation in adults to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures Approved by the FDA for expanded indication
Merck Keytruda (pembrolizumab) Stage IIB or IIC melanoma following complete resection in patients under age 12 Approved by the FDA for expanded indication
Octapharma Cutaquig immune globulin, subcutaneous (human)-hipp 16.5% solution Primary humoral immunodeficiency in patients under age two Approved by the FDA for expanded indication
Beigene

EUSA
Sylvant (siltuximab for injection) Idiopathic multicentric Castleman disease Approved in China

 

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