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ReGelTec has received European MDR CE Mark approval for its Class III HYDRAFIL System, a disc augmentation therapy designed to reduce pain, improve daily function & eliminate the need for invasive surgeries
Approval was based on a study of 75 pts showing over 80% improvement in Oswestry Disability Index (ODI) scores & >70% pain…
NEWS
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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…
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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.…
Shots:
RamSoft Inc. and Therapixel have entered into a commercial partnership to integrate Therapixel’s MammoScreen AI-powered breast imaging software into RamSoft’s PowerServer and OmegaAI platforms
This collaboration integrates Therapixel's MammoScreen, breast imaging AI, directly into RamSoft's platforms
Recent studies showed that MammoScreen improves radiologist performance with 8% higher sensitivity, 2% higher specificity, and 24% faster…
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InnoCare Pharma has approved Minjuvi (tafasitamab) + Lenalidomide, followed by Minjuvi monotx., for treating adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT)
Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, combined with lenalidomide, is already approved for treating eligible DLBCL pts. in Hong Kong, Macau,…
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KaliVir Immunotherapeuticsreported completion of the first cohort in P-I/Ib (STEALTH-001) study evaluating VET3-TGI as a monotx. and in combination with a checkpoint inhibitor in advanced, unresectable, or metastatic solid tumor pts.
The Data Safety Committee reviewed initial safety data and approved the progression of VET3-TGI to the next IT and IV dosing cohorts
VET3-TGI is an…
Shots:
Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada
Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic…
Shots:
Viz.ai has entered into a multi-year collaboration with Sanofi & Regeneron to deploy and evaluate its AI-powered chronic obstructive pulmonary disease (COPD) workflow solution
Sanofi, Regeneron, and Viz.ai collaborated on an AI-powered solution to improve care for high-risk COPD pts, focusing on how the Viz COPD module can enhance EHR workflows, access to care,…
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Viridian reported positive long-term durability data from the P-III (THRIVE) study evaluating 5 infusions of veligrotug (veli) or PBO (Q3W), with primary topline analysis at 15wks and follow-up to 52wks, in active thyroid eye disease (TED) pts. (N=30)
Study demonstrated that 70% (21/30) were proptosis responders at 15wks. and maintained at least a 2…
VantAI and Blueprint Medicines Expands License Agreement to Advance Induced Proximity Drug Discovery
Shots:
VantAI and Blueprint Medicines have expanded their 2022 collaboration, adding new drug target programs to develop therapies for critical medical needs
As per the expansion, VantAI will receive up to $1.67B in total including ~$270M R&D and regulatory milestones, and $1.4B commercial milestones across four joint target programs, along with tiered mid-single-digit sales based…

