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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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AbbVie & Xilio Therapeutics

AbbVie Collaborates with Xilio Therapeutics to Develop Next-Generation Tumor-Activated Immunotherapies

Shots: AbbVie & Xilio have entered into a collaboration & option-to-license agreement to leverage Xilio's proprietary tech for developing tumor-activated Abs As per the deal, Xilio will get $52M upfront (incl. $10M equity investment), & is entitled to receive ~$2.1B in contingent payments for option-related fees, milestones, & tiered royalties Xilio’s platform develops…

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Alloy Therapeutics & Pfizer

Alloy Therapeutics Enters into a Multi-Year Strategic Collaboration with Pfizer to Develop New Antibody Discovery Platform

Shots: Alloy Therapeutics has entered into a strategic collaboration with Pfizer to develop a platform designed to improve Pfizer’s capability to discover potent, specific, and effective antibodies for targets that are challenging to address with current antibody discovery technologies, including the use of Alloy’s ATX-Gx platform As per the agreement, Alloy will receive an…

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BridgeBio

BridgeBio’s Beyonttra (Acoramidis) Gets the EU approval to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: The EU granted marketing authorization to Beyonttra (acoramidis) to treat wild-type or variant ATTR-CM in adult pts.; launch expected in 1H’25 The approval was supported by the results of P-III (ATTRibute-CM) study of Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts.. It achieved its 1EP, showing a 42% reduced composite ACM &…

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