NEWS

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

Coherus BioSciences to Divest its Ophthalmology Franchise to Sandoz for $170M Up Front

Shots : Coherus signs an agreement with Sandoz to divest its ophthalmology franchise which includes a lead asset Cimerli (ranibizumab-eqrn) along with its supporting commercial infrastructure As per the terms of the agreement, Coherus will receive an all-cash consideration of $170M as up-front payment along with an additional amount for Cimerli product inventory &…

January 4, 2024

Glenmark Introduces Lirafit (Biosimilar, Liraglutide) for Type 2 Diabetes Mellitus in India

Shots : Following the approval from the Drug Controller General of India (DCGI), Glenmark has introduced the first biosimilar of Liraglutide under the brand name Lirafit (1.2mg, per day) for managing type 2 diabetes mellitus in India Lirafit gained approval based on a 24wks. study in type 2 diabetes mellitus Indian adult patients which showed…

January 3, 2024

Alvotech Reports Topline Results from the Study of AVT06 (Biosimilar, Eylea) for Eye Disorders

Shots : The (AVT06-GL-C01) confirmatory trial investigated the efficacy, safety, and immunogenicity of AVT06 vs Eylea for the treatment of neovascular (wet) AMD  The results revealed that the trial met its 1EP of baseline to wk. 8 in Best-Corrected Visual Acuity (BCVA) showing therapeutic similarity between AVT06 and Eylea AVT06, recombinant fusion protein, binds…

January 3, 2024

BMS Reports EMA’s Validation of Augtyro (repotrectinib) for the Treatment of Solid Tumors

Shots: The EMA has validated MAA of Augtyro for treating adults and pediatric patients (12yrs. & older) with ROS1+ and NTRK+ locally advanced or metastatic solid tumors incl. NSCLC The application was based on two P-I/II (TRIDENT-1 & CARE) trials assessing the safety, tolerability, PK and anti-tumor activity in adults with ROS1+ NSCLC or NTRK+…

January 2, 2024

LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)

Shots: The CHMP has granted positive opinion to Anzupgo cream (topical pan-JAK inhibitor) for treating moderate to severe chronic hand eczema (CHE), inadequately managed by topical corticosteroids Opinion was based on P-III (DELTA 1 & DELTA 2) trials assessing the safety & efficacy of Anzupgo (BID) vs vehicle for moderate to severe CHE. Those…

July 26, 2022

NEWS

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)

Coherus BioSciences to Divest its Ophthalmology Franchise to Sandoz for $170M Up Front

Glenmark Introduces Lirafit (Biosimilar, Liraglutide) for Type 2 Diabetes Mellitus in India

Alvotech Reports Topline Results from the Study of AVT06 (Biosimilar, Eylea) for Eye Disorders

BMS Reports EMA’s Validation of Augtyro (repotrectinib) for the Treatment of Solid Tumors

LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)

Contact US

FOLLOW US