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Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots:The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinomaThe OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib)OncoMate MSI Dx Analysis System…
3 hours ago

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March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma

Shots:The US FDA has granted RMAT designation to MB-105 for the treatment of r/r CD5-positive T-cell lymphomaDesignation was based on the ongoing P-II trial, which showed clinical activity with a favorable safety profile; initial data to be presented at ASH’25, with additional updates expected in 2026March Bio will pursue clinical & commercial…
4 hours ago

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EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots:EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & JapanAs per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…
5 hours ago

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Doc.com Launches AI & Blockchain Telemedicine Platform in the US

Shots:Doc.com launches its AI & blockchain-powered telemedicine platform in the US to improve patient access, data security, & care coordinationPts can securely connect with licensed in-state healthcare providers via mobile using the platform, with up to 15min. of complimentary teleconsultation offered during launch, available in eligible jurisdictions & subject to applicable regulations, followed…
7 hours ago

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Minze Health Partners with Medtronic to Expand Digital Bladder Monitoring Across EMEA

Shots:Minze Health has entered into a 3yr. agreement with Medtronic to commercialize its Minze Diary Pod, an automated bladder diary solution, across the EMEA regionPartnership will integrate the Diary Pod into the Sacral Neuromodulation (SNM) care pathway for pts with Overactive Bladder (OAB) receiving Medtronic’s InterStim therapy, allowing objective data collection during diagnosis…
7 hours ago

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RION Launches RION Vet to Advance Platelet-Derived Biologics in Animal Health

Shots:RION has launched RION Vet, a veterinary biotechnology subsidiary, with exclusive global rights to RION’s exosome-based therapeutic platform for animal healthRION Vet is developing ePEP-01, a cell-free, shelf-stable platelet-derived biologic, for equine musculoskeletal disorders, which was evaluated in over 50 horses for >4yrs., showing improvement in lameness, with favorable safetyRION Vet leverages…
9 hours ago

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Lyell Immunopharma Acquires Global Rights to LYL273 from Innovative Cellular Therapeutics in ~$860M Deal

Shots:Lyell has acquired global rights to LYL273 (excl. mainland China, Hong Kong, Macau & Taiwan) for the treatment of metastatic colorectal cancer & other GCC-expressing cancers from ICTAs per the deal, ICT will receive $40M upfront, 1.9M Lyell shares, ~$30M in clinical, ~$115M in late-stage regulatory, & ~$675M in sales milestones, plus ~1.85M additional…
1 day ago

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Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots:The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib)The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variantsAlso, clinical bridging studies…
1 day ago

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