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Briacell
NEWS

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…
April 17, 2025

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Ceribell
NEWS

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots: The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.) Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury Clarity algorithm allows seizure detection in both pediatric &…
April 17, 2025

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Telix Pharmaceuticals
NEWS

Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Shots: The IIT P-II (IPAX-Linz) trial assessed TLX101 (IV) in 8 glioblastoma pts with recurrent tumors & PET-confirmed amino acid uptake, who received adaptive dosing with ~4GBq before & ~2GBq after, 2L EBRT; 5/8 had MGMT-unmethylated tumors Trial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…
April 17, 2025

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Vivani Medical & Okava
NEWS

Vivani Medical & Okava Pharmaceuticals Extend Collaboration to Develop OKV-119 for Canine Cardiometabolic Diseases

Shots: Vivani Medical & Okava Pharmaceuticals have expanded their 2019 collaboration to develop OKV-119 for cardiometabolic conditions in dogs, which initially focused on cats Financial terms of the expanded agreement remain undisclosed but incl. future milestones & royalty payments to Vivani OKV-119 (GLP-1 receptor agonists) uses Vivani’s NanoPortal tech for steady drug delivery over time from…
April 16, 2025

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iCAD
NEWS

RadNet to Acquire iCAD for ~$103M

Shots: RadNet has entered into a definitive merger agreement to acquire iCAD in an all-stock transaction, through which iCAD will become a wholly owned subsidiary of RadNet As per the deal, iCAD stockholders will receive 0.0677 RadNet shares/ iCAD share, representing transaction value of ~$103M, or ~$3.61/share (~98% premium) on a fully diluted basis; closing…
April 16, 2025

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Biocon Biologics
NEWS

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots: Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26 Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
April 16, 2025

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Eisai, Biogen and BioArctic
NEWS

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Shots: The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA states Eisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…
April 16, 2025

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