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Celltrion
News

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, 20250Comments

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Infusing Automation: Suresh Kannan from Model N in an Illuminating Discussion with PharmaShots
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Infusing Automation: Suresh Kannan from Model N in an Illuminating Discussion with PharmaShots

Shots:  Identifying discrepancies remains a key challenge for manufacturers in mitigating revenue leakage and ensuring alignment with payer plans  Suresh Kannan, Model N’s Chief Product Officer, offers insights into the newly launched GenAI and enhanced data solutions aimed at optimizing revenue and ensuring compliance  He also outlines a strategic approach to formulary identification and emphasizes…
May 21, 20251Comment

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Ramsoft & Therapixel
News

RamSoft and Therapixel Form a Commercial Partnership For an Integrated AI Breast Imaging Solution

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…
May 21, 20250Comments

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Innocare Pharma
News

China’s NMPA Grants Approval to InnoCare Pharma’s Minjuvi + Lenalidomide to Treat R/R DLBCL

Shots: 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,…
May 21, 20250Comments

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Kalivir Immunotherapeutics
News

KaliVir Immunotherapeutics Reports Completion of First Cohort of P-I/Ib (STEALTH-001) Study in Advanced Solid Tumors

Shots: 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…
May 21, 20250Comments

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Fresenius Kabi
News

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra) Across Canada 

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…
May 21, 20250Comments

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Viz.ai, Sanofi & Regeneron
News

Viz.ai Enters a Multi-Year Partnership with Sanofi and Regeneron to Improve Management and Care of COPD

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,…
May 21, 20250Comments

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Viridian
News

Viridian Therapeutics Releases the Long-Term Durability Data Evaluating Veligrotug in P-III (THRIVE) Study in Active TED 

Shots: 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…
May 21, 20250Comments

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Vant AI & Blueprint Medicines
News

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…
May 21, 20250Comments

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