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BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.
Akadeum Life Sciences Announces Two New Microbubble Kits at Advanced Therapies Week
Akadeum Life Sciences notes: Unlike microbubbles, magnetic beads and columns are limited in their selection capacity and can damage more sensitive cell types, potentially decreasing cell viability and risking population integrity.
Geneoscopy Files Inter Partes Review Petition Challenging Exact Sciences’ Patent
Andrew Barnell, CEO and co-founder of Geneoscopy. “With the goal of expanding cancer screening options and improving outcomes for millions of patients, Geneoscopy seeks to ensure that Exact Sciences does not foreclose innovation and advancement in the field of cancer detection by claiming exclusive rights to diagnostic methods it did not invent. We strongly deny Exact Sciences’ allegations and will vigorously defend our ability to fulfill our mission to empower patients and providers to transform gastrointestinal health.”
Epredia Announces the U.S. Launch of SlideMate Laser | Provides State-of-the-Art Precision Slide Printing for Pathology Laboratories
Epredia has designed SlideMate Laser for clinical laboratories of any size looking to improve sample traceability.
Leading Pharma Adopts Veeva Vault Validation Management for Digital Validation Execution and Improved Efficiency
SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co. Ltd., a global biotech company, is using Veeva Vault Validation Management to streamline and accelerate their validation process. By adopting a validation solution with built-in best practices, the company can execute digital validation while centralizing data and improving visibility.
Thermo Fisher Scientific Launches PangenomiX Array to Support Population-Scale Disease Studies and Pharmacogenomics Research
The PangenomiX Array is currently the only research solution that combines four assays in one test: SNP genotyping, whole genome copy number variant detection, fixed copy number discovery, blood and HLA typing. The high-throughput array is designed to advance disease risk and detection research, population-scale disease research programs, ancestry and wellness testing, drug efficacy testing, and drug development research.
HORIBA Medical Launches Next Generation HELO Fully Automated Modular Hematology Solution
HELO 2.0 offers a highly flexible and efficient modular hematology solution that is fully scalable with many possible configurations for mid to large-scale laboratories.
Amgen Provides Regulatory Update on the Status of Lumakras® (Sotorasib)
This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. The FDA also issued a new postmarketing requirement for an additional confirmatory study to support full approval that will be completed no later than February 2028.
BrainStorm Granted Patents for Allogeneic Exosome Platform-Product in Neurological Disorder Treatments
The Australian patent Office granted patent No. 2019252987 titled 'Cell-Type Specific Exosomes and Use Thereof' for an isolated Exosomes population derived from MSC-NTF cells as well as a pharmaceutical composition for the treatment of neurodegenerative diseases.
GenSci Launches Global Innovation Hub in Shanghai
GenSci notes the construction of this facility is progressing as planned, and it is expected to be fully operational by 2027, providing a capacity to accommodate up to 2,000 R&D professionals.
