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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
Astrazeneca
AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC
Shots: Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRT Approval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…
May 22, 2025
Genentech & Orionis
Genentech Collaborates with Orionis to Identify and Develop Molecular Glue Therapies for Cancer Targets
Shots: Genentech has entered into a multi-year collaboration with Orionis to discover small-molecule monovalent glue drugs for novel & difficult oncology targets using Orionis’ Allo-Glue platform As per the deal, Orionis will receive $105M upfront & ~$2B in research, development, commercial, & sales milestones, with tiered royalties; Orionis will lead discovery & optimization, while Genentech…
May 22, 2025
Celltrion
Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations
Shots: FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…
May 22, 2025
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