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Gilead & Ideaya Biosciences

IDEAYA Enters Into an Additional Clinical Study Collaboration and Supply Agreement with Gilead Sciences

Shots: IDEAYAhas entered into an additional clinical study collaboration and supply agreement with Gilead Sciences to evaluate the efficacy and safety of IDE397 + Trodelvy in MTAP-Deletion NSCLC IDEAYA is currently enrolling patients in a monotx. expansion study for IDE397 in MTAP-deletion NSCLC and urothelial cancer, alongside the P-I/II study evaluating IDE397 with Trodelvy in…

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Sanofi & J&J

Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Shots: Sanofi and J&J have discontinued the P-III (E.mbrace) study of ExPEC9V after IDMC interim analysis due to insufficient efficacy against extraintestinal pathogenic E. coli , leading to a $250M impairment charge before tax The P-III trial assessed single dose of ExPEC9V (IM) vs PBO in adults (≥60yrs.) with UTI history in past 2yrs. to prevent invasive…

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CSL

CSL Behring Receives the EC Approval for Andembry as a Prophylactic Treatment of HAE

Shots: EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet) assessing Andembry vs PBO & OLE…

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J&J Medtech

Johnson & Johnson MedTech Launches Cereglide 92 Catheter System in the US for Acute Ischemic Stroke

Shots: J&J MedTech has launched the Cereglide 92 Catheter System with the Innerglide 9 delivery aid in the US to ease insertion & guidance of interventional devices in the neurovascular system Cereglide 92 features a .092” inner diameter with Innerglide 9 delivery aid, Brite-line tech for complete catheter visibility, & TruCourse for flexibility to…

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Dalan Animal Health

Dalan Animal Health Unlocks the Potential of Innate Immunity with its Vaccine Platform

Shots: Dalan Animal Health has developed shrimp vaccine for white spot syndrome virus (WSSV) & early mortality syndrome (EMS) using its innate immunity platform, extending its validation from honeybee vaccine to aquaculture Dalan’s shrimp vaccine (administered via the broodstock) will offer non-GMO as well as non-chemical alternative to conventional vaccines & has shown 62% &…

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Pfizer New

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…

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