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Moderna
Moderna Reports the EC Approval of mCOMBRIAX to Protect Against Influenza and COVID-19    
Shots:  The EC has approved mCOMBRIAX (mRNA-1083), a combination vaccine for the prevention of influenza and COVID-19 in patients ≥50 yrs. across all 30 EEA states    Approval was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone / Efluelda (a high dose influenza vaccine )+ Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability    MRNA-1010, Moderna’s…
Pulnovo Raises $100M Led by Medtronic to Advance PADN System for Pulmonary Hypertension
Shots: Pulnovo Medical secured an oversubscribed $100M financing round led by Medtronic, with existing participation from EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed, and Lilly Asia Ventures The Pulnovo Medical and Medtronic also entered a strategic commercial agreement to explore future global commercialization opportunities leveraging the commercial synergy between Pulnovo and Medtronic, along with Medtronic’s distinctive and…
EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors
Shots: EpiBiologics has dosed the first patient in a global P-I study evaluating EPI-326, a tissue-selective bispecific antibody targeting EGFR, in advanced solid tumors The first-in-human study will assess safety, tolerability, PK, and preliminary anti-tumor activity in pts with NSCLC and HNSCC, with potential expansion into colorectal cancer Preclinical data showed robust anti-tumor activity across…
LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis
Shots: The NMPA has approved Enstilar (calcipotriene/betamethasone dipropionate) for the treatment of adult patients with plaque psoriasis in China. Following NMPA approval, Enstilar is planned to launch in China later this year NMPA approval was backed by a P-III trial (n=604) in Chinese adults with plaque psoriasis, where QD Enstilar showed superior efficacy and met…
Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing
Shots: Piramal Pharma Solutions has entered into a strategic collaboration with Ajinomoto Bio-Pharma Services to support antibody-drug conjugate (ADC) development and manufacturing programs Under the agreement, Piramal will refer customers to Ajinomoto’s AJICAP platform for site-specific ADC conjugation, while Ajinomoto will direct clients to Piramal for CDMO manufacturing services across development and commercialization The collaboration…
Bavarian Nordic
Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya
Shots: Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.) Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…
Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System
Shots: The US FDA has granted 510(k) clearance to Philips for its Spectral CT Verida system, an AI-powered detector-based spectral CT platform for diagnostic imaging Verida integrates always-on spectral imaging with AI-based deep learning reconstruction to enhance image quality, reduce noise, and improve diagnostic precision across radiology, cardiology, and oncology applications The system enables simultaneous…