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Evaxion Licenses EVX-B3 Vaccine Candidate to Merck
Shots: Evaxion has granted Merck the rights to EVX-B3, a preclinical vaccine candidate under their Sep 2024 option & license agreement As per the deal, Merck will assume full responsibility & costs of further development of EVX-B3 in exchange for $7.5M upfront & ~$592M in development, regulatory & sales milestones, with net sales-based royalties EVX-B3…
September 26, 2025
Eli lilly
Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer
Shots: FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks. Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…
September 26, 2025
Eli lilly
Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease
Shots: The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers Approval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD pts The TRAILBLAZER-ALZ 2 trial showed…
September 26, 2025
Acadia Pharmaceuticals Reports Topline P-III (COMPASS PWS) Trial Data of Carbetocin for Hyperphagia in Prader-Willi Syndrome
Shots: Acadia Pharmaceuticals has reported topline P-III (COMPASS PWS) trial data of carbetocin (ACP-101; intranasal) in pts with hyperphagia in Prader-Willi syndrome The global trial evaluated carbetocin (3.2mg, TID) vs PBO for 12wks. in 175 pts (5 to 30yrs) with Prader-Willi syndrome & failed to meet its 1EP of change in HQ-CT alongside any 2EP Additionally,…
September 25, 2025
ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests
Shots: ClearNote Health has received the UKCA certification for its Avantect Multi-Cancer & Ovarian Cancer tests to detect multiple cancers & support early diagnosis of ovarian cancer, respectively The Multi-Cancer Detection Test screens multiple cancers from a simple blood sample using 5-hydroxymethylcytosine & genomic biomarkers in cell-free DNA, & was selected for the NCI-funded Vanguard…
September 25, 2025
Smart Meter Launches iAmbientHealth for Remote Patient Monitoring
Shots: Smart Meter has launched iAmbientHealth to passively track heart rate, respiration, movement & bed exits without wearables or cameras iAmbientHealth provides continuous real-time health insights & predicts health events up to 7 days in advance, where in a study with 200 pts, it predicted over 75% of hospital transfers & reduced hospitalizations by 50%…
September 25, 2025
Kashiv BioSciences and JAMP Pharma Launch Pexegra (Biosimilar, Neulasta) and Filra (Biosimilar, Neupogen) in Canada
Shots: Kashiv BioSciences & JAMP Pharma have launched Pexegra & Filra, biosimilar version of Neulasta & Neupogen, respectively, in Canada JAMP Pharma & Kashiv BioSciences entered an exclusive agreement to market Pexegra & Filra in Canada, with Kashiv’s facilities supporting JAMP’s commercialization efforts Pexegra (6mg/0.6mL) & Filra (300mcg/0.5mL & 480mcg/0.8mL) help treat CT-induced neutropenia by…
September 25, 2025
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