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Alvotech, Kashiv Biosciences & Advanz Pharma
NEWS

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots: The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNP Alvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech &…
March 26, 2025

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Huntleigh
NEWS

Huntleigh Healthcare Reports the US FDA’s 510(k) Clearance of Dawes-Redman CTG Analysis to Improve Non-Stress Test Interpretation in Fetuses

Shots: The US FDA has granted 510(k) clearance to the Dawes-Redman CTG analysis, improving non-stress test (NST) interpretation in fetuses to help prevent poor outcomes for babies & families Dawes-Redman CTG assesses NST traces against criteria of normality, using database of 100,000+ traces & their outcomes, by evaluating basal heart rate, sinusoidal rhythms, & short-term…
March 26, 2025

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Accent Theraoeutics
NEWS

Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025

Shots: Accent Therapeutics to present preclinical data of ATX-559 (DHX9 inhibitor) & ATX-295 (KIF18A inhibitor) at AACR 2025 Presentation will highlight ATX-559’s activity in cancers exhibiting genomic instability & replication stress in in vivo models, incl. dMMR/MSI-H colorectal & BRCA-altered triple-negative breast cancer, plus ATX-295’s activity in ovarian cancer & its relation with whole genome…
March 26, 2025

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Merck & Hengrui
NEWS

Merck Partners with Jiangsu Hengrui Pharmaceuticals for HRS-5346, Expanding its Cardio-Metabolic Portfolio

Shots: Merck has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346 As per the deal, Merck has obtained exclusive rights to develop, manufacture & commercialize HRS-5346 globally excl. Greater China region in exchange for $200M upfront & ~$1.77B in development, regulatory & commercial milestones, along with net sales-based royalties; closing expected…
March 25, 2025

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Alumis & Kaken
NEWS

Alumis and Kaken Pharmaceutical Enter Collaboration & Licencing Deal for ESK-001’s Development & Commercialization in Japan

Shots: Alumis & Kaken have partnered to develop, manufacture, & market ESK-001 for dermatology in Japan, with an option to expand into rheumatology & GI diseases As per the deal, Kaken will handle development, approval & marketing of ESK-001 in Japan in exchange for $40M upfront & near-term co-development costs, with ~$140M in milestones & field…
March 25, 2025

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Sanofi
NEWS

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Shots: The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…
March 25, 2025

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Avatar Medical & FX Shoulder Solutions
NEWS

Avatar Medical & FX Shoulder Solutions Reports the US FDA’s 510(k) Clearance of brAIn Shoulder Positioning System (SPS) for Arthroscopic Surgeries

Shots: The US FDA has granted 510(k) clearance to brAIn SPS for preoperative planning & implant placement in shoulder surgery brAIn SPS, developed via FX & Avatar, combines AI-driven imaging, with 3D avatar visualization for precise soft tissue assessment to optimize implant positioning & joint function while enhancing accuracy & recovery in comparison to conventional…
March 25, 2025

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New Drug Designations - February 2025
INSIGHTS+

New Drug Designations – February 2025

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA   The February 2025 report covers designations granted to 53 drugs and 4 medical devices, spanning 16 small molecules, 14 biologics, 18 cell and gene therapies & 4 medical devices among…
March 25, 2025

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