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Health Canada Approves Celltrion's Steqeyma® Biosimilar for Inflammatory Diseases
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Health Canada Approves Celltrion's Steqeyma® Biosimilar for Inflammatory Diseases
6 August 2024
Health Canada has authorized the use of Celltrion's Steqeyma®, a biosimilar of Stelara® (ustekinumab), for managing various persistent inflammatory diseases.
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Vaccinex's Pepinemab Shows Promise in SIGNAL-AD Trial for Alzheimer's
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Vaccinex's Pepinemab Shows Promise in SIGNAL-AD Trial for Alzheimer's
6 August 2024
Vaccinex Announces Promising Results from SIGNAL-AD Phase 1b/2 Trial of Pepinemab for Alzheimer's Disease.
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MT-303: Myeloid Therapeutics Launches Phase 1 HCC Trial with RNA CAR Targeting GPC3
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MT-303: Myeloid Therapeutics Launches Phase 1 HCC Trial with RNA CAR Targeting GPC3
6 August 2024
Myeloid Therapeutics begins administering MT-303, a new RNA CAR targeting GPC3, in a Phase 1 trial for late-stage hepatocellular carcinoma (HCC).
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SanBio's AKUUGO® for Treating Motor Paralysis in Brain Injury Patients: Approval Achieved
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SanBio's AKUUGO® for Treating Motor Paralysis in Brain Injury Patients: Approval Achieved
6 August 2024
SanBio Gains Approval for "AKUUGO® Suspension for Intracranial Use" (INN: Vandefitemcel) to Treat Persistent Motor Paralysis from Traumatic Brain Injuries.
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BioNTech Reports Positive Phase 2 Outcomes for mRNA Therapy BNT111 in Advanced Melanoma Patients
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BioNTech Reports Positive Phase 2 Outcomes for mRNA Therapy BNT111 in Advanced Melanoma Patients
5 August 2024
The combination therapy was well tolerated, and the safety profile of BNT111 with cemiplimab was consistent with previous trials of BNT111 with anti-PD-(L)1-based treatments.
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Tectonic Therapeutic Secures US IND Approval for TX45 Lead Program
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Tectonic Therapeutic Secures US IND Approval for TX45 Lead Program
5 August 2024
Tectonic Therapeutic has announced that the U.S. Food and Drug Administration has approved its Investigational New Drug application for TX45.
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Pamrevlumab Trial Results in Advanced Pancreatic Cancer: FibroGen's Update
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Pamrevlumab Trial Results in Advanced Pancreatic Cancer: FibroGen's Update
5 August 2024
FibroGen Releases Main Outcomes from Two Advanced Pamrevlumab Pancreatic Cancer Trials and Shares Corporate News.
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FDA Clears IND for Umoja's UB-VV111: A CD19 CAR T-Cell Therapy for Blood Cancers
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FDA Clears IND for Umoja's UB-VV111: A CD19 CAR T-Cell Therapy for Blood Cancers
5 August 2024
Umoja Biopharma Receives FDA Approval for IND Application of UB-VV111, a CD19 Targeted CAR T for Blood Cancers.
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EMA Approves Bio-Thera's BAT1706: A Bevacizumab Biosimilar to Avastin®
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EMA Approves Bio-Thera's BAT1706: A Bevacizumab Biosimilar to Avastin®
5 August 2024
The European Medicines Agency (EMA) has given its approval to Bio-Thera Solutions for BAT1706 (Avzivi®, bevacizumab), a biosimilar of Avastin®.
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Connext Successfully Gives Initial CNT201 Dose for Dupuytren’s Contracture
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Connext Successfully Gives Initial CNT201 Dose for Dupuytren’s Contracture
5 August 2024
Connext has revealed the initial successful administration of CNT201, its therapeutic solution for Dupuytren’s contracture, in patients.
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FDA Approves Vertex's Suzetrigine for Moderate-to-Severe Acute Pain
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FDA Approves Vertex's Suzetrigine for Moderate-to-Severe Acute Pain
2 August 2024
Vertex reveals FDA approval of New Drug Application for Suzetrigine for treating moderate-to-severe acute pain.
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PepGen Announces Promising Low-Dose Results in Phase 2 CONNECT1-EDO51 Trial for Duchenne Muscular Dystrophy Treatment
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PepGen Announces Promising Low-Dose Results in Phase 2 CONNECT1-EDO51 Trial for Duchenne Muscular Dystrophy Treatment
2 August 2024
PepGen reports encouraging results from low-dose group in ongoing CONNECT1-EDO51 Phase 2 trial for treating Duchenne Muscular Dystrophy with PGN-EDO51.
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