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Superluminal Medicines & Eli Lilly have partnered to develop small molecule therapeutics for undisclosed GPCR targets in cardiometabolic diseases & obesity, leveraging Superluminal’s drug discovery platform
As per the deal, Superluminal will use its platform to discover & optimize small molecules, while Lilly will obtain exclusive rights to develop & commercialize the candidates in…
NEWS
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The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectively
Approval was based on Part…
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The US FDA has granted full approval to Papzimeos (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), even though its BLA was originally submitted under the accelerated approval pathway
Approval was based on a P-I/II trial meeting its 1EP of safety as well as efficacy & showed 51% pts (18/35) achieving CR with…
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The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD)
Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025
Rilzabrutinib, a reversible covalent BTK inhibitor, is…
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PetPace has launched an Epilepsy Insights module to deliver low-latency, data-driven insights on epileptic events in dogs; available for beta testing in dogs with a confirmed epilepsy diagnosis
The Epilepsy Insights module is powered by the PetPace smart collar & uses AI as well as ML to manage canine epilepsy through continuous monitoring & automated…
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BioCardia has entered into an exclusive development & commercialization agreement with CART-Tech for Heart3D Fusion Imaging to improve 2D x-ray images used for cardiac biotherapeutic delivery & biopsy procedures
As per the deal, BioCardia secured global exclusive rights to CART-Tech’s IP for biotherapeutic interventions, plus exclusive US distribution rights for cardiac biopsy & global…
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Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1)
Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
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Pilatus Biosciences & Roche have entered into a clinical trial collaboration to evaluate PLT012 + atezolizumab for HCC pts
Under the collaboration, Roche will supply atezolizumab (Tecentriq) for Pilatus' P-I study of PLT012 in combination therapy for HCC, with plans to expand to other cancers
PLT012 is a humanized mAb that blocks CD36-driven lipid uptake, targeting…
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Basilea Pharmaceutica entered into an exclusive license deal with Venatorx Pharmaceuticals to acquire global rights to ceftibuten-ledaborbactam etzadroxil, a P-III oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for complicated urinary tract infections (cUTI), incl. pyelonephritis
Under the agreement, Venatorx will receive an upfront payment along with potential milestone payments in 2025 and will also be eligible…
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Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts
Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP
Bulumtatug Fuvedotin, a Nectin-4–targeting…

