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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

February 14, 2022
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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