Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Shots: The CHMP has recommended AVT06, a biosimilar version of Eylea (aflibercept 2 mg), across all 30 EEA states AVT06 is a recombinant fusion protein that inhibits VEGF to reduce neovascularization and vascular permeability. The CHMP recommends MAA for wet AMD, visual impairment from macular oedema due to RVO (branch or central), diabetic macular oedema…

ByDipanshu DixitJune 24, 2025

News

SpringWorks Therapeutics’ Nirogacestat Receives the CHMP’s Positive Opinion for Desmoid Tumors

Shots: The CHMP has recommended Nirogacestat as a monotx. for adults with progressing desmoid tumors needing systemic treatment, the EC’s decision is expected in Q3’25 Opinion was supported by the MAA on P-III (DeFi) global trial (N=142) assessing Nirogacestat (n=700) vs PBO (n=72), which met the 1EP, showing a 71% reduction in PFS vs PBO,…

ByDipanshu DixitJune 23, 2025

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LIFE SCIENCES | DAILY NEWS | JUN 23, 2025 | PHARMASHOTS

ByDipanshu DixitJune 23, 2025

News

Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Shots: The EC has approved Vyvgart (efgartigimod alfa) 1000mg for SC injection as a monotx. for adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior corticosteroid or immunoglobulin treatment in all 30 EEA states The EC approval was based on the ADHERE trial, showing 66.5% (214/322) of VYVGART SC-treated pts showed…

ByDipanshu DixitJune 23, 2025

News

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia)

Shots: The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards The EC’s approval was supported by the clinical evaluations…

ByDipanshu DixitJune 23, 2025

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LIFE SCIENCES | DAILY NEWS | JUN 20, 2025 | PHARMASHOTS

ByDipanshu DixitJune 20, 2025

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LIFE SCIENCES | DAILY NEWS | JUN 18, 2025 | PHARMASHOTS

ByDipanshu DixitJune 18, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in May 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 2 New Chemical Entites in May 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were GSk’s Blenrep to Treat R/R Multiple Myeloma PharmaShots has compiled a list of 4 drugs that have been…

ByDipanshu DixitJune 17, 2025