NEWS

Takeda Reports EC’s Approval of Hyqvia as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Shots Takeda’s Hyqvia has been approved as maintenance therapy for treating chronic inflammatory demyelinating polyneuropathy (CIDP) on stable IVIG therapy valid throughout the EU plus Iceland, Liechtenstein, Norway & Northern Ireland The approval is based on the results from the P-III (ADVANCE-CIDP 1) study assessing Hyqvia’s safety and efficacy as a maintenance therapy to…

January 29, 2024

Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis

Shots : Celltrion has submitted BLA to the US FDA seeking approval for CT-P47 in both IV and SC route of administrations based on the P-III study The P-III study assesses the safety, efficacy, PK, and immunogenicity of CT-P47 vs Actemra for treating moderate to severe active rheumatoid arthritis with inadequate response to methotrexate…

January 28, 2024

BMS Receives the CHMP’s Positive Opinion for Abecma (idecabtagene vicleucel) to Treat Multiple Myeloma

Shots: The CHMP positive opinion was based on the results from the P-III (KarMMa-3) clinical trial evaluating Abecma vs standard regimens in patients with r/r multiple myeloma following 2-4 prior lines of therapy. The 1EP of the study was PFS & 2EPs were ORR & OS Following a median follow-up of 30.9mos., the study showed…

January 26, 2024

Evive’s Ryzeneuta (efembalenograstim alfa) Receives the CHMP’s Positive Opinion for the Treatment of Neutropenia and Febrile Neutropenia

Shots: The CHMP has granted a positive opinion to Ryzeneuta (20mg, IV) based on its safety and efficacy evaluation results as compared to PBO The recommendation was made by CHMP for EC’s approval as medicinal product for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with…

January 26, 2024

Boan Biotech Highlights Clinical Updates for BA6101 (biosimilar, Prolia) and BA1102 (biosimilar, Xgeva) to Treat Various Indications

Shots: The company has completed patient enrolment in P-III trial which evaluates the safety, efficacy, PK & immunogenicity of BA6101 & BA1102 vs reference drugs (Prolia & Xgeva) for the treatment of various indication across Europe, United States & Japan Boan also conducted a meeting in Germany to highlight the PK results from the…

January 15, 2024

STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases

Shots : Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara…

January 10, 2024

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Shots: The approval was supported by the P-III (MycarinG) study evaluating the safety, efficacy & tolerability of Rystiggo (7 or 10mg/kg) vs PBO in gMG patients. The 1EP of the study includes a change in MG-ADL score at Day43 & 2EPs include a change in MG-C score, QMG, patient-reported outcomes at Day43 and AEs The…

January 8, 2024

Bayer and Regeneron Receive the EC’s Approval for Eylea (aflibercept, 8mg) for the Treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

Shots: The approval was granted based on the results from the P-III (PULSAR) & P-II/III (PHOTON) clinical trials evaluating the safety & efficacy of Eylea 8mg vs 2mg dosed Q8W following initial monthly dosing in patients (N=1,164) with nAMD & DME. The 1EP of both the studies was non-inferior BCVA changes Both the studies met…

January 8, 2024

Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum

Shots: Zelsuvmi (berdazimer topical gel, 10.3%) received the US FDA’s approval as a novel drug for the treatment of molluscum infections in adults & pediatric patients aged ≥1yrs. Zelsuvmi is expected to be commercially available in the US by H2’24 The company evaluated the safety & effectiveness of the US FDA-approved Zelsuvmi in P-III clinical…

January 8, 2024

Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)

Shots : The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara Accord BioPharma…

January 4, 2024

NEWS

Takeda Reports EC’s Approval of Hyqvia as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis

BMS Receives the CHMP’s Positive Opinion for Abecma (idecabtagene vicleucel) to Treat Multiple Myeloma

Evive’s Ryzeneuta (efembalenograstim alfa) Receives the CHMP’s Positive Opinion for the Treatment of Neutropenia and Febrile Neutropenia

Boan Biotech Highlights Clinical Updates for BA6101 (biosimilar, Prolia) and BA1102 (biosimilar, Xgeva) to Treat Various Indications

STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum

Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)

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