Shots:INBRAIN Neuroelectronics has entered into a strategic collaboration with Microsoft to apply agentic AI powered by Microsoft’s cloud & data infrastructure to enhance real-time precision neurology & next-gen brain-computer interface (BCI) therapeuticsThe partnership will leverage Microsoft’s Azure AI infrastructure, incl. time-series large language models & data analytics with INBRAIN’s graphene-based neural platform, allowing…
Shots:Transition Bio has entered into a drug discovery collaboration & license option agreement with Voyager Therapeutics to identify & develop selective small molecules targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS) & frontotemporal dementiaAs per the deal, Transition Bio will discover & optimize TDP-43–targeting small molecules, after which Voyager may license exclusive global…
Shots:Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks.Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…
Shots:Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…
Shots:The US FDA has received the BLA seeking accelerated approval of atacicept for treating adults with immunoglobulin A nephropathy (IgAN), with the FDA’s decision expected in 2026The BLA is supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in 431 adults with IgAN, assessing eGFR-based kidney…
Shots:SanegeneBio has entered into a global research & licensing deal with Eli Lilly to advance RNAi candidates for metabolic diseases, leveraging SanegeneBio’s LEAD (Ligand & Enhancer Assisted Delivery) techUnder the deal, SanegeneBio will discover & identify LEAD-based RNAi molecules for each program, while Lilly will oversee IND-enabling studies, clinical development, & commercialization; the…
Shots:The P-III (CORE: n=617 & CORE2: n=446) trials assessed olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults; the US FDA’s sNDA filing is expected by 2025 endBoth trials met their 1EP with ~72% PBO-adjusted fasting triglyceride (TG) reduction at 6mos., sustained to 12mos., while 89% (50mg) & 88%…
Shots:AstraZeneca has reported P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks.Trial met its 1EP of delayed time to first HES worsening or flare & reduced the risk of HES worsening/flare by 65%Trial met all 2EPs, showing…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below: Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC Read More: Daiichi Sankyo Genentech Reports P-III (ALLEGORY) Trial…
Shots:Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG)EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure timesThe company has planned to launch EndoZip in select EU centers &…

