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Novartis
NEWS

Novartis Reports the CHMP Positive Opinion for Remibrutinib for Chronic Spontaneous Urticaria (CSU) 

Shots: The CHMP has recommended approval of remibrutinib for CSU in adults with inadequate response to H1-antihistamines, with a final decision from the EC expected within ~2 mos.  Opinion was supported by the global P-III REMIX-1 & 2 trials in 925 pts uncontrolled on second-generation H1-antihistamines, where remibrutinib showed superiority vs PBO in ISS7, HSS7 & UAS7 at Wk 12, with itch and hive improvement from Wk 1 sustained to Wk 52, along with…
February 26, 2026

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Moderna
NEWS

Moderna’s mCOMBRIAX Receives the CHMP Positive Opinion to Protect Against Influenza and COVID-19   

Shots:  The CHMP has recommended approval of mCOMBRIAX (mRNA-1083), a combination vaccine for prevention of influenza and COVID-19 in patients ≥50 yrs. If granted, the approval would be valid in all 30 EEA states  Opinion was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone High‑Dose / Efluelda + Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where…
February 26, 2026

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Moderna
NEWS

Moderna Reports the EC Approval of mNEXSPIKE to Protect Against COVID-19 

Shots:  The EC has approved mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (aged≥12 yrs)   Approval was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (aged ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination   mNEXSPIKE showed 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in a descriptive sub-group analysis mNEXSPIKE showed 13.5%…
February 12, 2026

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VIEWPOINTS_Mohamed Eid_2023
VIEWPOINTS

Unlocking Approval: Mohamed Eid Dives into the Exciting Approval of Jardiance for Adult CKD Treatment in a Captivating Chat with PharmaShots

Shots:  Mohamed Eid, VP of Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, at Boehringer Ingelheim, in a stimulating conversation with PharmaShots sheds light on the recent approval of Jardiance for the treatment of adults with chronic kidney disease   Jardiance’s EMPA Kidney P-III trial results demonstrated a 28% relative risk reduction vs placebo. Jardiance…
December 5, 2023

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