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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Ascletis Pharma | ASC61 | Advanced solid tumors | IND approved by the FDA |
Pardes Bio | PBI-0451 | SARS-CoV-2 infections and associated diseases | IND approved by the FDA |
CereVasc | eShunt System | Hydrocephalus | Investigational device exemption granted by the FDA |
Antengene | ATG-037 | Metastatic solid tumors | Approval for a phase 1 trial granted by Australia’s regulatory authority |
Akeso | AK115 | Pain | Approval for a phase 1 trial granted by China’s regulatory authority |
Revolo Biotherapeutics | ‘1805 | Rheumatoid arthritis | Approval for a phase 2 trial granted by the UK’s regulatory authority |
Revolo Biotherapeutics | ‘1805 | Noninfectious, active, intermediate, or posterior uveitis or panuveitis | Approval for a phase 2 trial granted by the UK’s regulatory authority |
EuBiologics | EuCorVac-19 COVID-19 vaccine | COVID-19 | Approval for a phase 3 trial granted by South Korea’s regulatory authority |
Trials Initiated | |||
CureVac | CVSQIV seasonal influenza vaccine | Seasonal influenza | Initiation of phase 1 trial |
MapLight Therapeutics | ML-007 | Schizophrenia and dyskinesia | Initiation of phase 1 trial |
Sirnaomics | STP707 | Solid tumors | Initiation of phase 1 trial |
Active Biotech | Tasquinimod | Relapsed or refractory multiple myeloma | Initiation of phase 1b/2 trial |
HutchMed | HMPL-453 | Advanced solid tumors | Initiation of phase 1b/2 trial |
uniQure | AMT-130 | Huntington’s disease | Initiation of phase 1b/2 trial in Europe |
Neoimmunetech | NT-I7 (efineptakin alfa) | High-risk skin cancers | Initiation of phase 2a trial |
Actuate Therapeutics | Elraglusib (9-ING-41) plus Folfirinox | Advanced pancreatic cancer | Initiation of phase 2 trial |
BioRestorative Therapies | BRTX-100 | Chronic lumbar disc disease | Initiation of phase 2 trial |
Dompé | Cenegermin | Sjögren's-related dry eye disease | Initiation of phase 3 trial |
Sunovion Otsuka |
Nonracemic amisulpride (SEP-4199) | Major depressive episodes associated with bipolar 1 disorder | Initiation of phase 3 trial |
TearClear | TC-002 | Glaucoma | Initiation of phase 3 trial |
Approvals | |||
Allergan | Juvederm Volbella XC | Infraorbital hollows | Approved by the FDA |
Azurity Pharmaceuticals | Fleqsuvy (baclofen oral suspension) | Spasticity from multiple sclerosis or spinal cord injuries | Approved by the FDA for a new dosing regimen |
Sanofi | Enjaymo (sutimlimab-jome) | Cold agglutinin disease | Approved by the FDA |
Novavax | Nuvaxovid COVID-19 vaccine | COVID-19 | Conditional approval granted in the UK |

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