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Drug & Device Pipeline News
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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