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…

ByDipanshu DixitJanuary 3, 2024

NEWS

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…

ByDipanshu DixitJanuary 3, 2024

NEWS

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+…

ByDipanshu DixitJanuary 2, 2024

INSIGHTS+

Disease of the Month – Amyotrophic Lateral Sclerosis (ALS)

Shots: To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research To continue the series for the disease of the month, PharmaShots brings this month a summary of the disease Amyotrophic Lateral Sclerosis (ALS), a rare…

ByDipanshu DixitMay 11, 2023

NEWS

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…

ByDipanshu DixitJuly 26, 2022

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA's EUA for REGN-COV2 Ab combination while Health Canada accelerated…

ByDipanshu DixitJanuary 14, 2021

Dipanshu Dixit

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

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

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

Disease of the Month – Amyotrophic Lateral Sclerosis (ALS)

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

PharmaShots’ Key Highlights of Fourth Quarter 2020

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