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SpringWorks Therapeutics
NEWS

SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

Shots: The EC has approved Ogsiveo as a monotx. for adults with progressing desmoid tumors needing systemic treatment Approval was based on global P-III (DeFi) trial (N=142) assessing Ogsiveo (150mg, BID, n=70) vs PBO (n=72) in adults with progressing desmoid tumors Trial met its 1EP with 71% reduction in risk of disease progression & showed…
August 19, 2025

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NEWS

SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC

Shots: The US FDA has granted BTD to izalontamab brengitecan (iza-bren) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations progressing on or after EGFR TKI & Pt-based CT Designation was backed by data from 3 ongoing trials: BL-B01D1-101 & BL-B01D1-203 in China led by Sichuan Biokin, & the global BL-B01D1-LUNG-101…
August 18, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 11, 2025 – Aug 14, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Animal Health, and Biosimilars. Check out our full report below:    Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease  Read More: Novartis  Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR)…
August 14, 2025

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MAGAZINE

PharmaShots Magazine-August-2025 Edition

Aesthetic and beauty industry, underplayed by cosmeceuticals, shapes a soaring market worth $312.33B. Cosmeceuticals are known for their medical benefits beyond cosmetics and typically come in the forms of topical creams, serums, and lotions Let’s unearth the secrets of cosmeceuticals like never before through engaging articles, illustrative infographics, regulatory updates, and much more   The…
August 14, 2025

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Sanofi
NEWS

Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease

Shots: The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD) Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025 Rilzabrutinib, a reversible covalent BTK inhibitor, is…
August 14, 2025

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Merck new
NEWS

Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 2025

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