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Gyre Therapeutics
Gyre Therapeutics Releases P-III Trial Findings on Hydronidone for Chronic Hepatitis B-Associated Liver Fibrosis
Shots: Gyre Therapeutics has reported P-III trial data assessing Hydronidone (270mg, QD, PO) + entecavir (n=123) vs PBO + entecavir (n=124) in 248 Chinese pts with chronic hepatitis B-associated liver fibrosis for 52wks.; 1 untreated subject was excluded from analysis Trial met its 1EP, with 52.85% vs 29.84% achieving ≥1-stage fibrosis regression (Ishak score) & 2EP,…
May 23, 2025
Petvivo Holdings & PiezoBioMembrane
Petvivo Holdings Collaborates with PiezoBioMembrane to Develop Functional Biomaterials
Shots: PetVivo Holdings & its subsidiary PetVivo Animal Health has entered into a master services agreement with PiezoBioMembrane to develop biocompatible biomaterial that mimics mammalian extracellular matrix As per the deal, PetVivo & PiezoBio will co-develop a piezo-biomaterial combining ECM biomaterial & piezoelectric nanofibers to enable biologically activated healing, regeneration, & remodelling of damaged or…
May 23, 2025
Roche
Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy
Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR) Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…
May 23, 2025
Sandoz
Sandoz Launches Pyzchiva Autoinjector (Biosimilar, Stelara) in the EU for Chronic Inflammatory Diseases
Shots: Sandoz has launched Pyzchiva autoinjectors, a biosimilar version of Stelara (ustekinumab) in EU to treat pts (≥6yrs.; ≥60kg) with plaque PsO, PsA, Crohn’s disease & pediatric plaque PsO; commercially available in Spain, with further expansion to continue In Sep 2023, Sandoz & Samsung Bioepis entered into a development & commercialization agreement, granting Sandoz rights to…
May 23, 2025
Vigil Neuro
Sanofi to Acquire Vigil Neuroscience for ~$470M
Shots: Sanofi has entered into an agreement to acquire Vigil Neuroscience incl. its asset VG-3927 (TREM2 agonist), strengthening its neurology pipeline; Vigil’s VGL101 program is not a part of the acquisition As per the deal, Sanofi will acquire Vigil for ~$470M, with shareholders receiving $8/share in cash & a non-transferable CVR of $2/share payable upon the…
May 22, 2025
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