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Pfizer New
NEWS

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 +…
February 13, 2025

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AbbVie & Xilio Therapeutics
NEWS

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…
February 13, 2025

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Alloy Therapeutics & Pfizer
NEWS

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…
February 12, 2025

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BridgeBio
NEWS

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 &…
February 12, 2025

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SpringWorks Therapeutics
NEWS

SpringWorks Therapeutics Receives US FDA Approval for Gomekli to Treat Neurofibromatosis Type 1 Associated Symptomatic Plexiform Neurofibromas (NF1-PN)

Shots: The US FDA has approved Gomekli for pts (≥2 years) with unresectable NF1-PN based on P-IIb (ReNeu) trial & has also granted RPD PRV to SpringWorks; availability in US market is expected within 2wks; MAA is under EMA review with decision expected in 2025 The P-IIb (ReNeu) study assessed Gomekli(2mg/m^2, BID) in 2 Arms…
February 12, 2025

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Regeneron
NEWS

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The US FDA has accepted resubmitted BLA for linvoseltamab to treat r/r MM in pts who received ≥4L or ≥3L & were unresponsive to the last line (PDUFA: Jul 10, 2025) after resolving third-party fill/finish manufacturing issues; MAA is under EMA review Application was backed by P-I/II (LINKER-MM1) trial data, assessing linvoseltamab (200mg)…
February 12, 2025

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Celltrion
NEWS

Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)

Shots: The US FDA has approved Avtozma IV/SC (biosimilar, Actemra) to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19; expected to be commercially available by August 2025 in US Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in…
February 12, 2025

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Pfizer & Astellas
NEWS

Pfizer and Astellas Report Follow-up Data from P-III (KEYNOTE-A39/EV-302) Trial of Padcev + Keytruda for Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Shots: Pfizer & Astellas have reported follow-up data from P-III (KEYNOTE-A39/EV-302) trial assessing Padcev + Keytruda vs Pt-based CT in previously untreated la/mUCpts (n=886) The 12mos. follow up study (mFU: 29.1mos.) showed reduced risk of death by 49% & decrease in PFS by 52% (mPFS: 12.5 vs 6.3mos.) with improved mOS (33.8 vs 15.9mos.), where OS…
February 12, 2025

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