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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

October 11, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
4D Molecular Therapeutics 4D-150 Wet age-related macular degeneration IND approved by the FDA
4D Molecular Therapeutics 4D-710 Cystic fibrosis IND approved by the FDA
Tenax Therapeutics Delayed-release imatinib Pulmonary arterial hypertension IND approved by the FDA
Cocrystal Pharma CC-42344 Pandemic and seasonal influenza A Approval for a phase 1 trial granted by Australia’s regulatory authority
Revelation Biosciences REVTx-99 Allergic rhinitis and chronic nasal congestion Approval for a phase 1b trial granted by Australia’s regulatory authority
Intellia Therapeutics NTLA-2002 Adults with hereditary angioedema Approval for a phase 1/2 trial granted by New Zealand’s regulatory authority
Pharmaxis PXS-5505 Bone marrow cancer myelofibrosis Approval for the phase 2 portion of a phase 1c/2a trial approved by the FDA
Trials Initiated
AlzeCure Pharma ACD856 Alzheimer’s disease Initiation of phase 1 trial
Antares Pharma ATRS-1902 Adrenal crisis rescue Initiation of phase 1 trial
Appello Pharmaceuticals AP-472 Parkinson’s disease Initiation of phase 1 trial
Dialectic Therapeutics DT2216 Relapsed or refractory solid tumor and hematologic malignancies Initiation of phase 1 trial
Inhalon Biopharma IN-006 Treatment of COVID-19 Initiation of phase 1 trial
Rafael Pharmaceuticals CPI-613 (devimistat) in combination with hydroxychloroquine Clear-cell sarcoma Initiation of phase 1 trial
Altimmune pemvidutide Nonalcoholic fatty liver disease Initiation of phase 1b trial
Elicio Therapeutics ELI-002 mKRAS+ solid tumors Initiation of phase 1/2 trial
Lutris Pharma LUT014 Radiation-induced dermatitis in breast cancer patients Initiation of part two of phase 1/2 trial
Precirix NV CAM-H2 HER2-positive metastatic cancer Initiation of phase 1/2 trial
Viracta Therapeutics nanatinostat plus valganciclovir EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors Initiation of phase 1b/2 trial
Boston Pharmaceuticals BOS-580 Nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis Initiation of phase 2a trial
BioNTech BNT122 (autogene cevumeran) personalized vaccine Stage II/III colorectal cancer Initiation of phase 2 trial
Covicept Therapeutics PSJ-539 Mild-to-moderate COVID-19 Initiation of phase 2 trial
PharmaTher Holdings ketamine Levodopa-induced dyskinesia in patients with Parkinson’s disease Initiation of phase 2 trial
Vaxart COVID-19 oral tablet vaccine Prevention of COVID-19 Initiation of phase 2 trial
Cassava Sciences simufilam Alzheimer’s disease Initiation of phase 3 trial
VYNE Therapeutics Amzeeq (minocycline) topical foam, 4% Moderate-to-severe acne Initiation of phase 3 trial in China
Approvals
PerkinElmer PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay RT-PCR test to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus Emergency Use Authorization granted by the FDA
Kite Pharmaceuticals Tecartus (brexucabtagene autoleucel) Adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia Approved by the FDA
ChoiceSpine Triton sacroiliac joint fixation system Degenerative sacroiliitis and sacroiliac joint disruption Approved by the FDA

 

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