Biopharmaceuticals News

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• September 2024: Parexel announced the strengthening of its Real World Research (RWR) offering by integrating its Scientific Data Organization and Real World Evidence capabilities. This initiative aims to better meet growing customer needs and enhance the company's ability to provide valuable insights using real-world evidence for clients worldwide.
• August 2024: Eli Lilly announced positive topline results from the SURMOUNT-1 three-year study evaluating the efficacy and safety of tirzepatide for long-term weight management and delay in progression to diabetes in adults with pre-diabetes and obesity or overweight. Tirzepatide significantly reduced the risk of progression to type 2 diabetes by 94% among adults with pre-diabetes and obesity or overweight compared to placebo.
• August 2024: Pfizer and BioNTech announced top-line results from their Phase 3 clinical trial evaluating a combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals aged 18-64. The combination vaccine met one of its two primary immunogenicity objectives.
• July 2024: Thermo Fisher Scientific announced a partnership with the National Cancer Institute (NCI) to advance the myeloMATCH precision medicine clinical trial. This collaboration utilizes Thermo Fisher's next-generation sequencing technology to rapidly match patients with appropriate clinical trials for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), aiming to accelerate research into new treatments for these conditions.
• July 2024: ICON plc expanded its decentralized clinical trial capabilities by integrating advanced digital health technologies to enhance patient engagement and data collection.

• October 2024: Abcam, now a subsidiary of Danaher Corporation, unveiled a new range of exosome-specific antibodies and kits to support advanced exosome research, focusing on improving detection and characterization methodologies.
• September 2024: Bio-Techne announced the development of a novel exosome-based diagnostic platform aimed at enhancing biomarker discovery and development across multiple disease areas, including oncology and neurodegenerative disorders.
• August 2024: Qiagen expanded its exosome product line by releasing the "miRCURY Exosome Kits," which utilize precipitation methods to efficiently isolate exosomes from various biofluids, facilitating downstream molecular analyses.
• July 2024: Fujifilm Wako Chemicals U.S.A. Corporation launched the "MagCapture™ Exosome Isolation Kit PS Ver.2," an enhanced version aimed at improving the purity and yield of exosome isolation for research applications.
• June 2024: Thermo Fisher introduced the "Exosome Isolation and Analysis Suite," a comprehensive toolkit designed to streamline exosome research by integrating isolation, characterization, and analysis processes.

• August 2024: Adaptimmune Therapeutics PLC was granted approval by the US FDA for TECELRA (afamitresgene autoleucel), marking it as the first engineered cell therapy approved for use in solid tumors and therapy for a rare, soft tissue cancer, synovial sarcoma.
• January 2024: Abbvie and Umoja Biopharma established a strategic collaboration to develop various in-situ generated CAR-T cell therapy candidates in oncology by incorporating Umoja's proprietary VivoVec gene delivery platform.

• July 2023: Pfizer invested USD 25 million in Caribou Biosciences to progress an immune-cloaked allogeneic CAR-T cell therapy, CB-011. The company is currently evaluating the cell therapy in a Phase I CaMMouflage clinical trial for relapsed or refractory multiple myeloma.
• April 2023: InflaRx N.V.'s Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, was granted an Emergency Use Authorization by the United States Food and Drug Administration for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation, or extracorporeal membrane oxygenation.

• January 2024: Rice University of the United States launched the Rice Synthetic Biology Institute, which aims to catalyze collaborative research in synthetic biology and its translation into technologies that benefit society.
• May 2023: GenScript Biotech Corporation, the sponsor of the SynBioBeta Conference in Oakland, California, showcased the latest synthetic biology tools and techniques with strategic partner Allozymes and a diverse line-up of key opinion leaders (KOLs).

• May 2024: Oxford Nanopore Technologies introduced a new Pharmacogenomics (PGx) Beta Programme for advancing personalized medicine with the combination of Twist Bioscience’s next-generation sequencing (NGS) target enrichment technology with Oxford Nanopore’s sequencing platform.
• February 2024: Nicklaus Children's Hospital in South Florida adopted the next-generation pharmacogenomics technology, Applied Biosystems PharmacoScan Solution and GeneTitan MC Fast Scan Instrument, to develop personalized treatment plans for the patients and reduce the complications from drug interactions and side effects.

• January 2024: CRISPR Therapeutics received the US Food and Drug Administration's approval for CASGEVY (exagamglogene autotemcel [exa-cel]). It is a CRISPR/Cas9 gene-edited cell therapy for the treatment of transfusion-dependent beta-thalassemia (TDT) in patients aged 12 years and older.
• January 2024: Danaher Corporation and the Innovative Genomics Institute (IGI) launched a collaborative center for developing gene-editing therapies for rare and other diseases. Their goal is to create a new model for future development of a wide range of genomic medicines.

• November 2023: QIAGEN NV launched the Microbiome WGS (whole-genome sequencing) SeqSets which is a comprehensive Sample to Insight workflow designed to provide an easy-to-use solution that maximizes efficiency and reproducibility in microbiome research. 
• June 2023: Zymo Research launched its full-length 16S sequencing service offering researchers high-quality, full-length 16S rRNA gene sequencing for microbiome analysis.

• In August 2022, Applied StemCell, Inc. (ASC), a cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, expanded its Current Good Manufacturing (cGMP) facility. ASC has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, process development, and QC/QA space.
• In January 2022, stem cell manufacturing startup Cellino Biotech raised a USD 80 million Series A financing round led by Leaps by Bayer along with 8VC, Humboldt Fund, and new investors including Felicis Ventures and Khosla Ventures, that could fix a problem holding the biotech industry back. Cellino plans to expand access to stem cell-based therapies with the goal to build the first autonomous human cell foundry in 2025.

• Dec 2022: ArcticZymes Technologies (AZT) upscaled the production of ArcticZymes Proteinase. In addition, the company launched a glycerol-free formulation of the proteinase that enables the company to support customers requiring a lyophilization-compatible formulation of the proteinase for use in high-throughput molecular diagnostic workflows.
• Oct 2020: A team of biochemists from Chulalongkorn University became the first researchers in Thailand to study proteolytic enzymes (proteinase K) for the COVID-19 virus at a molecular level in 3D, possibly leading to the development of COVID-19 treatments.