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Expanding COPD Treatment Horizons: Caterina Brindicci and Frank Sciurba on Tozorakimab’s Phase III Journey  

Shots:  Tozorakimab reinforced its potential as a first-in-class COPD biologic with a third positive Phase III trial (MIRANDA), complementing OBERON and TITANIA and strengthening AstraZeneca’s regulatory package while validating IL-33 as a critical therapeutic pathway in COPD.  The MIRANDA trial demonstrated efficacy across one of the broadest COPD populations studied for a biologic, including former and current smokers, patients across…

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IL-33 Breakthrough in COPD: Caterina Brindicci and Frank Sciurba on Tozorakimab’s Phase III Success 

Shots:  Tozorakimab demonstrated a potential first-in-class advantage in COPD, becoming the first IL-33 biologic to achieve positive outcomes across three pivotal Phase III trials (OBERON, TITANIA, and MIRANDA), highlighting the clinical relevance of targeting both reduced and oxidized forms of IL-33 to reduce exacerbations in a broad patient population.  The LUNA Phase III programme enrolled the most comprehensive…

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Merck Report the EC Approval of Enflonsia for RSV Prevention in Infants 

Shots:  The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants  The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs…

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Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Shots: Samsung Bioepis has entered into a global license, development & commercialization agreement with Sandoz for up to five biosimilars, incl. SB36 (preclinical), a biosimilar version of Entyvio (vedolizumab) Samsung Bioepis will handle development, manufacturing & regulatory filings, while Sandoz will lead commercialization globally (excl. China, Hong Kong, Taiwan, Macau & Republic of Korea) The…

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