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BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…

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Cepheid Receives IVDR CE Mark for Xpert GI Panel to Detect 11 Gastrointestinal Pathogens

Shots: Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…

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Boehringer Ingelheim Inks ~$ 479.6M Deal with Immunitas Therapeutics for a Preclinical Antibody Program

Shots: BI has entered into a global licensing agreement with Immunitas for a preclinical antibody program being developed for chronic inflammatory & autoimmune diseases As per the deal, BI will obtain global rights to develop, manufacture, & commercialize the antibody program in exchange for an upfront payment, up to €407.5M (~$479.6M) in development, regulatory, &…

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Rigel Signs ~$445M Licensing Pact with Arvinas and Pfizer for Veppanu

Shots: Rigel has entered into an exclusive, global license agreement with Arvinas & Pfizer to develop, manufacture & commercialize FDA-approved Veppanu (vepdegestrant) for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. As per the deal, Rigel will pay Arvinas & Pfizer $70M upfront, $15M in upon completion of transition activities, & ~$320M in milestones plus tiered royalties…

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Tolion Health AI Launches AI-Powered Tolion Brain Coach App for Brain Health, Longevity, and Prevention of Alzheimer’s Disease

Shots: Tolion Health AI has launched Tolion Brain Coach, a new App within its Brain Health Platform designed to deliver personalized, preventive, & predictive insights for cognitive health using AI-driven analytics & wearable-device data Platform leverages Tolion’s Knowledge Engine & Brain Score to generate tailored recommendations aimed at strengthening cognitive resilience & reducing neurodegenerative disease…

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