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The US FDA has approved the Nexus Aortic Arch Stent Graft for the treatment of aortic arch disease
Approval was supported by the 1yr. results from the TRIOMPHE IDE trial assessing Nexus in aortic arch disease, incl. chronic aortic dissections, in pts at high risk for open surgical repair, which showed safe & effective treatment in…
NEWS
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Gilead has entered into a definitive agreement to acquire Tubulis, making it an ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation
As per the deal, Gilead will acquire Tubulis for $3.15B upfront & ~$1.85B in contingent milestone payments; closing is expected in Q2’26
Acquisition will expand…
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Alloy Therapeutics has entered into a collaboration & license agreement with Biogen to advance antisense therapeutics against multiple undisclosed targets using Alloy’s AntiClastic ASO Platform
As per the deal, Alloy will receive an upfront payment, along with additional milestone payments & tiered royalties on any products resulting from the collaboration
The AntiClastic ASO platform…
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Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapy
At mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…
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Organogenesis has reported the trial completion of PuraPly AM, assessing it in combination with SoC vs SOC alone for the management of non-healing diabetic foot ulcers (DFUs)
The 170-patient trial achieved its 1EP, showing significant wound closure at 12wks., with the company planning to publish the study results soon in a journal
PuraPly AM…
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Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia
Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph
Denoza will be available in a prefilled syringe format
Ref: Apotex | Image: Apotex | Press Release…
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CuraTeQ Biologics has reported topline P-III trial data assessing BP11, a biosimilar version of Xolair (omalizumab) vs Xolair in pts with chronic spontaneous urticaria
Trial met its 1EPs in CSU at 300mg, evaluating ISS7 changes at Wk. 12 across 608 pts at ~80 sites, demonstrating equivalence between BP11 & Xolair within predefined margins
Additionally,…
Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease
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Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED)
The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…
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Sanofi has reported P-IIb (AIRCULES), P-IIa (DUET) PoC & P-IIb (VELVET) data assessing lunsekimig (SC) in adults with mod. to sev. asthma, CRSwNP, & in mod. to sev. atopic dermatitis, respectively
In AIRCULES, lunsekimig met 1 & 2EPs, reducing exacerbations & improving lung fuction as measured by pre-BD FEV1 vs PBO, while in DUET it met…
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Neurocrine Biosciences has entered into a definitive agreement to acquire Soleno, expanding its endocrinology & rare disease portfolio
As per the deal, Neurocrine will acquire Soleno for $53/share in cash, representing a total transaction equity value of $2.9B
Acquisition will add Vykat XR (diazoxide choline) to Neurocrine's portfolio for the treatment of hyperphagia with Prader-Willi…

