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Roche

Roche Receives CE Mark for its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

Shots: Roche has received the CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test, an in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream The assay was evaluated in a study of 607 subjects with cognitive complaints or objective memory impairment of unknown aetiology, where Elecsys ApoE4 assay showed…

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Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

Shots: The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…

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Samsung Bioepis and Epis NexLab Collaborate with G2GBIO on Long-Acting Semaglutide Development

Shots: Samsung Bioepis & Epis NexLab have entered a research collaboration & license agreement with G2GBIO to develop novel therapeutics using proprietary microsphere-based sustained-release technology As per the deal, Samsung Bioepis will receive full licensing rights to a long-acting Semaglutide asset, an option to license another asset, & first negotiation rights for three additional assets,…

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GSK

GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing immune response & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was…

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Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria

Shots: OLE study assessed repinatrabit (JNT-517) in adolescents with PKU. Early time-point data remain embargoed to preserve parent-study blinding, with additional randomized-period results to be presented later First cohort receiving repinatrabit (75mg, PO, BID) showed a 67% mean reduction in Phe from baseline (Day 56/OLE Month 1), with responses seen in all pts, incl. prior…

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Enodia Acquires Kezar’s Sec61 Program to Advance Targeted Protein Degradation Pipeline

Shots: Enodia has acquired Kezar’s Sec61-based discovery & development program assets, strengthening its understanding of Sec61 selectivity mechanisms & expanding translational insights to accelerate progress toward key clinical milestones As per the deal, Kezar will receive a $1M upfront, ~$127M in development, regulatory, & commercial milestones, plus tiered royalties on future net sales Enodia’s platform…

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PRISM BioLab and Receptor.AI Partner to Develop a Drug Discovery Platform

Shots: PRISM has partnered with Receptor.AI to develop an AI-navigated, physics-guided platform for discovering orally available small molecules targeting intracellular protein–protein interactions (PPIs), membrane proteins & complex receptor systems Collaboration will combine PRISM’s PepMetics Tech, 3D small molecules designed to mimic α-helix & β-turn motifs, with Receptor.AI’s AI-driven molecular design engine to identify hit, lead, &…

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Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases

Shots: Natera has reported the commercial launch of Zenith genomics, a next-generation whole genome sequencing (WGS) assay designed to enhance the detection of rare diseases in the US The platform combines whole genome sequencing with long-read sequencing confirmation to detect genomic features such as tandem repeat expansions, supporting diagnosis of rare & ultra-rare conditions, &…

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