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Chengdu Origen & Vanotech has reported the first pts dosing in Vanotech-led P-I (VAN-2401) trial assessing KH658 for wet age-related macular degeneration (wet AMD) in the US
The P-I trial will assess safety, tolerability, & efficacy of single suprachoroidal KH658 gene therapy in ~9 previously treated wet AMD pts that are responsive to anti-VEGF therapy…
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P-Ib/II (TUPELO) trial (enrolment ongoing) assessed REC-4881 (4 or 8mg, QD) in FAP, with P-II evaluating efficacy via upper & lower endoscopy at Wk. 0, 13 (on-treatment), & 25 (off-treatment) in pts (≥55yrs.) with APC mutations
As of Mar 17, 2025, 4mg (n=6) showed a median 43% polyp burden decrease; 5/6 had reductions of…
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The US FDA has approved Mometamax Single (gentamicin, posaconazole, & mometasone furoate otic suspension) to treat otitis externa in dogs; commercially available by the summer of 2025
Mometamax Single has shown favorable efficacy, with 80.5% resolution of clinical signs in dogs vs 19.6% with PBO
Mometamax Single is a single-dose in-clinic treatment for otitis…
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The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25)
Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…
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Repare has out-licensed its discovery platform incl. SNIPRx, SNIPRx-surf, & STEP2 , along with certain intellectual property to DCx
As per the deal, Repare will get $4M as upfront & near-term payments, 9.99% equity in DCx with dilution protection, & future potential out-licensing, clinical & commercial milestones, with low-single digit tiered sales royalties; Repare will…
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AstraZeneca has reported P-III (LOGOS & KALOS) trial results evaluating Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts (n=~4400) with uncontrolled asthma
Trial met its 1EP, with BGF 320/28.8/9.6μg showing significant improvement in forced expiratory volume in 1 second (FEV1) AUC 0 to 3hrs. at…
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Merck Animal Health has entered into a binding evaluation & option agreement with AmacaThera to develop long-acting formulations for veterinary use
Collaboration will leverage AmacaThera’s AmacaGel hydrogel platform to develop single-injection veterinary therapeutics with enhanced sustained drug delivery
AmacaGel is a fast-gelling hydrogel composed of 2 established polymers, designed to liquefy under shear force…
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The UK’s MHRA has approved Vimkunya for active immunization against CHIKV disease in individuals (≥12yrs.); launch expected in the summer of 2025. Application submitted to Health Canada, with potential approval anticipated in H1’26
Approval was based on 2 P-III trials (n>3,500) that met their 1EP of rapid immune response within 1wk., with 97.8% of…
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Haleon and Brightseed have partnered to accelerate the discovery of plant-based bioactive compounds using Brightseed’s AI platform, Forager, supporting Haleon to create innovative health solutions
Forager will be directly accessible to Haleon scientists, enabling AI-powered identification of natural compounds and their health-related mechanisms, streamlining R&D and product development
Forager bioactive discovery has already demonstrated…

