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The US FDA has accepted sBLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked MMP associated with masseter muscle activity in adults
sBLA was supported by 2 P-III (M21-416 and M21-417) studies, both of which met their 1EPs & showed improvements in the severity of MMP vs…
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SOPHiA GENETICS has entered a global collaboration with AstraZeneca to develop, validate, & commercialize two companion diagnostics (CDx) supporting precision oncology therapies
The multi-year collaboration will leverage SOPHiA’s decentralized clinical trial assays & CDx capabilities to advance development & commercialization of the CDx programs
As per the deal, SOPHiA GENETICS will develop its Solid Tumor…
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The US FDA has granted 510(k) clearance to the OMNI Ultra Surgical System for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG)
The OMNI platform is backed by extensive clinical evidence showing sustained IOP reduction and reduced medication use, with the OMNI Ultra remaining on…
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Integer and KKR have entered into a definitive agreement under which an affiliate of investment funds managed by KKR will acquire Integer, delisting it from NYSE
As per the deal, KKR will acquire Integer in an all-cash transaction valued at $127 per share, representing the total enterprise value of ~$5.7B
As a KKR portfolio…
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Galaxy has received CE Mark under the EU MDR 2017/745 for its SEAL Embolization System, following assessment by Notified Body DQS Medizinprodukte. Launch expected across selected EU markets, with FDA’s PMA application underway
The SEAL Embolization System is an intrasaccular device for endovascular treatment of ruptured & unruptured wide-neck intracranial aneurysms, supporting aneurysm sizes…
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Nurix has enrolled the first patient in the global P-III (DAYBreak CLL-306) study assessing bexobrutideg in pts with r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor
The trial, conducted under the collaboration between Nurix and Roche, is expected to enroll ~620 pts, where they will be randomized…
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The EC has approved an extension of the indication of MenQuadfi to incl. infants (≥6wks.) for protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, & Y
Approval was supported by extensive data from the MET58 clinical study, which evaluated the immunogenicity, safety, & tolerability of MenQuadfi in infants from 6wks. of…
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Biocon has reported the commercial launch of Yesafili, a biosimilar version of Eylea 2mg (aflibercept), in the US, which was previously approved & granted interchangeable designation
In the P-III (INSIGHT) study in Diabetic Macular Edema (DME), Yesafili showed no clinically meaningful differences from Eylea in PK, safety, efficacy, or immunogenicity
Yesafili is a VEGF inhibitor…
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Lantheus to merge with a wholly-owned subsidiary of Curium US, combining Curium’s global theranostics platform with Lantheus’ US radiodiagnostics business; closing expected in H1’27
As per the deal, Curium will acquire Lantheus for $102.5/share in cash, with shareholders eligible for ~$12/share in non-transferable CVRs, representing total consideration of up to $114.50/share & a transaction…
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Pathos AI has entered into a licensing agreement with Jiangsu Alphamab Biopharmaceuticals for JSKN016, a TROP2/HER3 bispecific ADC independently developed by Alphamab
As per the deal, Pathos AI will receive exclusive rights to research, develop, manufacture & commercialize JSKN016 outside Greater China, funding all related costs, while Alphamab retains exclusive rights in mainland China,…

