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QIAGEN Teams Up with NVIDIA to Advance AI-Driven Drug Discovery

Shots: QIAGEN to integrate its Digital Insights bioinformatics business with NVIDIA accelerated computing & the NVIDIA BioNeMo platform to strengthen AI applications in drug discovery Partnership leverages graph-based AI that apply retrieval & reasoning techniques across biomedical knowledge graphs to help researchers analyze complex biological data & validate AI-generated insights, supporting practical applications across the…

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Sensome Reports the INSPECT Study Results of its In Situ Tumor Detection Technology for Lung Cancer

Shots: Sensome has reported results from its INSPECT study assessing its microsensor technology integrated into a smart stylet for bronchoscopic lung biopsy in 27 pts across Australia & France In the study, the smart stylet was inserted into the biopsy needle to capture tissue readings immediately before biopsy, with histopathology confirming measurement accuracy & cross-validating…

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Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Shots: Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…

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GSK

GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The Japanese MHLW has approved GSK's Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased…

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Bayer

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Shots: The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…

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Hansa Biopharma Grants European and MENA rights of Idefirix to SERB Pharmaceuticals in a €115M Deal

Shots: Hansa has granted SERB exclusive development & commercialisation rights to Idefirix (imlifidase) in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland & the MENA region  As per the deal, Hansa will receive €110M upfront & an additional €5M upon acceptance of the full approval filing for Idefirix by the EMA. Hansa will also support SERB in…

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