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mAbxience and Abiogen Pharma Enter into a Strategic Licensing Agreement for Biosimilar across Italy
Shots:  mAbxience, majority-owned by Fresenius Kabi and partially by Insud Pharma, has partnered with Abiogen Pharma in a strategic licensing agreement to develop & commercialize a biosimilar in Italy  As per the agreement, mAbxience will hold marketing authorization, while Abiogen Pharma handles commercialization and marketing in Italy  This collaboration leverages mAbxience’s biosimilar development expertise and…
May 26, 2025
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
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