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Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Hummingbird Bioscience | HMBD-002 | Cancers with VISTA-mediated immune suppression | IND approved by the FDA |
| Instil Bio | ITIL-168 | Advanced melanoma | IND approved by the FDA |
| Viewpoint Molecular Targeting | VMT-α-NET | Imaging of neuroendocrine tumors | IND approved by the FDA |
| Telix Pharmaceuticals | TLX250 (177Lu-DOTA-girentuximab) | Kidney cancer | IND approved by the FDA |
| Sigilon Therapeutics | SIG-005 | Mucopolysaccharidosis Type I | Phase 1/2 trial authorized by the UK regulatory authority |
| Excision BioTherapeutics | EBT-101 | CRISPR-based therapy for chronic HIV | IND approved by the FDA |
| Neurogene | NGN-101 | Batten disease | IND approved by the FDA |
| Magenta Therapeutics | MGTA-117 | relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes | IND approved by the FDA |
| Neovasc | COSIRA-II | Refractory angina | Investigational Device Exemption approved by the FDA |
| Trials Initiated | |||
| Alzamend Neuro | AL001 | Dementia related to Alzheimer’s disease | Initiation of phase 1 trial |
| Celldex | Subcutaneous formulation of CDX-0159 | Chronic urticarias | Initiation of phase 1 trial |
| Legend Biotech | LB1901 | Relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma | Initiation of phase 1 trial |
| Pacylex Pharmaceuticals | PCLX-001 | NonHodgkins lymphomas and solid tumors | Initiation of phase 1 trial |
| GammaDelta Therapeutics | GDX012 | Acute myeloid leukemia | Initiation of phase 1 trial |
| Icosavax | IVX-121 | Respiratory syncytial virus/human metapneumovirus vaccine | Initiation of phase 1/1b trial |
| ALX Oncology | ALX148 (evorpacept) with rituximab and lenalidomide | Indolent and aggressive nonHodgkins lymphoma | Initiation of phase 1/2 trial |
| NLS Pharmaceuticals | Quilience | Excessive daytime sleepiness and cataplexy | Initiation of phase 2 trial |
| Perception Neuroscience | PCN-101 (R-ketamine) | Treatment-resistant depression | Initiation of phase 2a trial |
| DiaMedica Therapeutics | DM199 | Acute ischemic stroke | Initiation of phase 2/3 trial |
| VistaGen Therapeutics | PH94B | Adults with social anxiety disorder | Initiation of phase 3 trial |
| Zynerba Pharmaceuticals | Zygel (cannabidiol formulated in a transdermal gel) | Children and adolescents with Fragile X syndrome | Initiation of phase 3 trial |
| Axsome Therapeutics | AXS-12 | Narcolepsy | Initiation of phase 3 trial |
| Biogen | nusinersen | Later-onset spinal muscular atrophy | Initiation of phase 3 trial |
| Approvals | |||
| Visby Medical | Reverse transcription-polymerase chain reaction COVID-19 test | Pooled testing of up to five patient samples | Emergency Use Authorization (EUA) granted by the FDA |
| Cepheid | Xpert Xpress CoV-2/Flu/RSV+ diagnostic test | COVID-19, influenza and respiratory syncytial virus | EUA granted by the FDA |
| Quanterix | Simoa SARS-CoV-2 N protein antigen test | COVID-19 | EUA granted by the FDA |
| BeiGene | Brukinsa (zanubrutinib) | Relapsed or refractory marginal-zone lymphoma | Approved by the FDA |
| Takeda Pharmaceutical | Exkivity (mobocertinib) | EGFR Exon20 insertion+ nonsmall-cell lung cancer | Approved by the FDA |
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