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Hikma
Hikma Pharmaceuticals Acquires Novugen’s US FDA ANDA Approved Trametinib
Shots: Hikma has acquired the Novugen's US FDA ANDA approved trametinibtablets and also entered into a commercial agreement with Novugen Under the agreement, Hikma will be responsible for all the US sales and marketing of trametinib while Novugen will manufacture and supply them to Hikma. Furthermore, when product is launched Hikma will have 180 days…
April 18, 2025
Sanofi
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, 2025
Innocare Pharma
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, 2025
Briacell
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
Ceribell
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
Vivani Medical & Okava
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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