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Viewpoints_Anton Yarovoy
VIEWPOINTS

Driving Precision Medicine Education: A Star Wars-Themed Talk on a Needed Approach

Shots:    Precision Medicine is a rapidly evolving field offering targeted treatments for optimal patient care    Education around testing is a critical need as many barriers exist that create practice gaps to patient identification   Testing State Awareness (TSA) is a critical component that needs to complement Brand and Disease State Awareness campaigns    Anton Yarovoy, Group Product…
April 18, 20250Comments

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Sanofi
News

Sanofi Enters a ~$1.84B Global License Agreement with Earendil Labs for HXN-1002 & HXN-1003

Shots: Earendil Labs has granted Sanofi exclusive global rights to develop HXN-1002 & HXN-1003 bispecific antibodies for autoimmune & inflammatory bowel diseases As per the deal, Earendil Labs will receive $125M upfront, ~$1.72B in development & commercial milestones, incl. a near-term $50M payment, & tiered royalties ranging from high-single to low-double digits Developed using Earendil…
April 17, 20250Comments

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Innocare Pharma
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InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

Shots: China’s NMPA has accepted NDA of zurletrectinib (ICP-723) for the treatment of pts (≥12yrs.) with advanced solid tumors having NTRK gene fusions In a registrational trial, zurletrectinib demonstrated favorable safety & strong efficacy, with the ability to overcome acquired resistance to the 1st generation TRK inhibitors in mentioned pts Zurletrectinib is a next-generation pan-TRK inhibitor…
April 17, 20250Comments

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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, 20250Comments

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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, 20250Comments

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Neurelis
News

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Shots: The US FDA has approved Valtoco for short-term treatment of acute repetitive seizures (seizure clusters) in pts (≥2yrs.) with epilepsy Approval was based on P-I/IIa trial assessing safety & PK of Valtoco, which showed favorable safety & efficacy with easy administration in pts who had episodes of frequent seizures; data was presented at CNS…
April 17, 20250Comments

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Viewpoints_Kate Flathers
VIEWPOINTS

Streamlining Pharmaceutical Claims: Kate Flathers from Kalderos in a Stimulating Conversation with PharmaShots

Shots:   Streamlining claims transactions remains a major challenge for pharmaceutical manufacturers. The financial leakage owing to non-compliant and duplicate claims costs manufacturers a fortune   Using Kalderos' Truzo platform, manufacturers can pay covered entities directly while maintaining transparency and compliance  Kate Flathers, Chief Product Officer at Kalderos, addresses the need for a compliant model for claims…
April 17, 20250Comments

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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, 20250Comments

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