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AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals
Shots:     The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway  Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain  Sipavibart was discovered…
January 9, 2025
J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2024 (Part 01)
Shots: The first dose of the J.P. Morgan Special: Dealmaker of the Year report based on the total number of deals signed in 2024 Last year, Roche inked 38 deals comprising acquisitions, contract services, development & commercialization, facility purchase, R&D, platform/product purchases, and sales/co-promotion Leveraging DealForma’s invaluable insights, PharmaShots brings an on-demand report…
January 8, 2025
Biocytogen Partners with Acepodia to Develop Bispecific Antibody and Dual-Payload ADCs to Treat Complex Tumors
Shots: Biocytogen & Acepodia have entered into a strategic collaboration to evaluate dual-payload bispecific antibody-drug conjugate (BsAD2C) program in complex tumors by combining the former's RenLite platform with Acepodia's Antibody-Dual-Drugs Conjugation (AD2C) tech Under the agreement, Biocytogen will provide a bispecific antibody from its RenLite platform, while Acepodia will combine 2 distinct payloads using…
January 8, 2025
Avenzo Therapeutics Join Forces with DualityBio to Develop AVZO-1418 (DB-1418) for Solid Tumors
Shots: Avenzo Therapeutics and DualityBio have signed an exclusive license agreement to develop, manufacture & commercialize the former’s AVZO-1418/DB-1418 across the globe (excl. Greater China) As per the terms, DualityBio will get $50M upfront, ~$1.15B development, regulatory and commercial milestones as well as tiered royalties in Avenzo’s territory AVZO-1418, an EGFR/HER3-targeting ADC developed…
January 8, 2025
Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System
Shots: Simpson Interventions reported the grant of IDE by the US FDA to Acolyte Image-Guided Crossing & Re-Entry Catheter System plus 510(k) clearance for its Shadow Catheter Acolyte System intends to enables cardiologists with revascularization of coronary chronic total occlusion (CTO). In Mar 2024, it was designated with the US FDA’s BDD and included…
January 8, 2025
Fresenius Kabi
Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)
Shots: Following the NOC approval of Tyenne (tocilizumab) & Idacio (adalimumab), Fresenius Kabi Canada has received Health Canada NOC for Otulfi (ustekinumab), a biosimilar to Stelara for Crohn's disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis NOC approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent…
January 8, 2025
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