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Fresenius Kabi
NEWS

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…
March 27, 2025

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Exelixis
NEWS

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.) Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…
March 27, 2025

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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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