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The FDA approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of adults with complicated urinary tract infections (cUTIs), including acute pyelonephritis caused by susceptible gram-negative organisms. The approval came through nearly a month after the European Medicines Agency adopted a positive opinion on authorisation of the injectable antibiotic combination. In a twist of fate, the FDA also issued a complete response letter on the same day to Venatorx Pharmaceuticals and Melinta Therapeutics for their combination of cefepime and taniborbactam in cUTI, asking them to submit additional chemistry, manufacturing, and controls data.The approval was based on the Phase III ALLIUM study, involving 1034 patients with cUTI who were randomly assigned to receive an infusion of either Exblifep or piperacillin/tazobactam every 8 hours. The study’s primary endpoint was a composite of clinical cure and microbiological eradication at the test-of-cure visit.The company noted that 79.1% of patients in the Exblifep group achieved the primary endpoint, significantly higher than the 58.9% in the piperacillin/tazobactam group. Exblifep was well tolerated and the safety profiles of the two were comparable.Enmetazobactam, an extended-spectrum beta-lactamase inhibitor, was first discovered in 2008 by Orchid Pharma and subsequently out-licensed to Allecra for further development. While Allecra holds the marketing rights for Exblifep in the US, it has granted exclusive licenses to Advanz Pharma and Shanghai Haini to commercialise the combination in the EU and Greater China, respectively. Orchid stated that the combination is expected to hit the US market in the next couple of quarters.

DUBLIN--( BUSINESS WIRE )--The "Next-Generation Sequencing: Emerging Clinical Applications and Global Markets" report has been added to ResearchAndMarkets.com's offering. Since NGS platforms can sequence an entire genomic region or even an entire genome, a single test can examine hundreds or thousands of clinically important genetic variations. This means that one test can replace multiple conventional single-gene tests, providing an advantage in price and in the amount of precious sample needed for the test itself. NGS is often more accurate and reliable than existing diagnostics. This can result in better clinical outcomes. For example, NGS can increase the pregnancy success rates in in vitro fertilization applications. Also, in rare genetic diseases, NGS can increase the success rates for determining a molecular diagnosis. The NGS platform enables companies to expand the menu of disorders/diseases over time after initial launch of a test. This strategy has been employed in reproductive health applications, for example, launching a test to initially screen for aneuploidies, and then later expanding the test to include screening for additional genetic variants. These features of NGS platforms provide a solid basis for the use of this technology in the clinic. The scope of the report includes clinical NGS technologies, applications, industries, initiatives, patents, and companies. The markets for NGS-based diagnostics are given for the years 2020, 2021, 2022, 2023 and 2028. This report reviews the main sequencing technologies and explains why genetic variation is important in clinical testing. It then discusses some of the significant research initiatives that impact clinical NGS applications. Liquid biopsy formats are discussed. The main market driving forces are also discussed. The report examines the markets by test complexity, clinical indication and test purpose. Test complexity refers to the plex level (i.e., the number of genetic markers that can be analyzed within a sample) and coverage (e.g., the extent to which the genome is covered) of the test. Examining the market by test complexity provides valuable insight into which products (e.g., sample preparation, NGS instrument, informatics, etc.) will be in demand in the future. The report provides market data and forecasts for NGS diagnostics by specific applications, including those for oncology, cardiovascular diseases, clinical microbiology/infectious diseases, Mendelian disorders, metabolic/immune disorders, neurological disorders, reproductive health, and transplant medicine. Industry sectors analyzed include DNA sequencing instruments; long-read sequencing; sequencing informatics; target enrichment; CTC capture and detection; liquid biopsy; cancer screening/early detection; direct-to-consumer testing; and noninvasive prenatal testing. More than 100 companies in the clinical NGS industry are profiled in this report. The Report Includes 41 data tables and 237 additional tables An overview of the global market for emerging clinical applications of next-generation sequencing Analysis of global market trends, featuring historical revenue data for 2020 to 2022, estimates for 2023, as well as forecasts for 2028, including projections of compound annual growth rates (CAGRs) through 2028 Evaluation of the current market size and revenue growth prospects, accompanied by a market share analysis by disease indication, test complexity, test purpose, application and geographic region Discussion of market opportunities for clinical NGS products, clinical applications, industry structure, regulatory scenarios and use of NGS-based diagnostics and technologies Coverage of genome mapping programs, technological advances and innovations in NGS platforms, and the Ion Torrent Genexus System from Thermo Fisher Scientific and the Magnis NGS Prep System from Agilent Technologies Inc Description of NGS-oriented tests such as non-invasive prenatal testing (NIPT) and pre-implantation genetic testing (PGT), and a discussion of their advantages Market share analysis of the key companies and a look at their proprietary technologies, strategic alliances and other key market strategies, plus a patent analysis Profiles of the leading players, including Illumina Inc., Thermo Fisher Scientific Inc., QIAGEN, Agilent Technologies Inc., and BGI Genomics Key Attributes: Report Attribute Details No. of Pages 492 Forecast Period 2023 - 2028 Estimated Market Value (USD) in 2023 $21.9 Billion Forecasted Market Value (USD) by 2028 $52.9 Billion Compound Annual Growth Rate 19.3% Regions Covered Global Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Overview Liquid and Tissue Biopsy Clinical NGS Market Growth Drivers of Clinical NGS Key Trends Industry Chapter 4 Technology Background Importance of DNA Genetic Variation and Analysis Genetic Analysis Technologies Sequencing in Clinical Applications Sequencing Technologies History of DNA Sequencing Sanger Sequencing Technology NGS Platforms Short-Read Platforms Long-Read Platforms Informatics Technologies Base Calling Mapping to a Reference Sequence Variant Analysis Artificial Intelligence Technologies Clinical Sequencing Technology Challenges Chapter 5 Clinical NGS Initiatives and Emerging Technologies R&D Initiatives and Programs 1+ Million Genomes Access to Treatment and Testing (ACTT) Access to Comprehensive Genomic Profiling Coalition (ACGP) Africa Pathogen Genomics Initiative Blood Profiling Atlas Cancer-ID Cancer Moon Shots Program China Precision Medicine Initiative ClinGen CTC Trap Consortium diaRNAgnosis Project Early Cancer Detection Consortium EpiFemCare France Genomic Medicine Plan Friends of Cancer Research Project Genomic Medicine Sweden HCA-Organoid Human Cell Atlas Human Immunomics Initiative Immunomonitor Consortium Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy Program Intervene Liquid Biopsies and Imaging for Improved Cancer Care Liquid Biopsy-Based Malignant Tumor Early Screening Technology Research and Development Project Liver Cancer Early Screening Comprehensive Prevention and Control Project Lung Cancer Genomic Screening Project for Individualized Medicine in Asia Million Veteran Program Medical Genome Initiative MedSeq Precision Medicine Initiative Prompt QuIP Project SPHERES Target ALS Diagnosis Initiative TopMed Treehouse Childhood Cancer Initiative Very Rare Cancer Consortium Worldwide Innovative Networking (WIN) Consortium Single-Cell Research Cambridge Single-Cell Analysis Core Facility Harvard Medical School Single-Cell Core Mayo Medical Genome Facility National Center for Single-Cell Biology Next-Generation Single-Cell Analysis Program Single-Cell Analysis Core UC San Francisco Single-Cell Analysis Center The Wistar Institute of Anatomy and Biology Population Sequencing Projects Chapter 6 Clinical NGS Applications Chapter 7 Clinical NGS Industry Chapter 8 ESG Development Chapter 9 Acquisitions and Strategic Alliances Chapter 10 Clinical NGS Markets Chapter 11 Patent Review Chapter 12 Company Profiles Agilent Technologies Inc. Bgi Genomics Co. Ltd Illumina Inc. Qiagen Thermo Fisher Scientific Inc. Accuragen Holdings Adaptive Biotechnologies Alcen Ambry Genetics Amoy Diagnostics Co. Ltd. Angle Plc Apostle Sciences Arcedi Biotech Aps Armonica Technologies Inc. Arup Laboratories Asuragen Inc. Baylor Genetics Becton, Dickinson And Co. Berry Genomics Beijing Biocaptiva Ltd. Biocept Inc. Biodesix Biofluidica Biolidics Ltd Biological Dynamics Biomodal Bionano Genomics Bio-Rad Laboratories Inc. Bio-Techne C2I Genomics Capio Biosciences Caredx Inc. Caris Life Science Cegat Gmbh Cell Microsystems Centrillion Genomics Technologies Claret Bioscience Clear Note Health Clinical Genomics Technologies Cyclomics Cygnus Biosciences Co. Ltd. Danaher Dante Labs Datar Cancer Genetics Ltd. Delfi Diagnostics Diacarta Diagnologix Llc Diagnomics Inc. Diamir Bio Dnalytics Dnanexus Inc. Earlydiagnostics Epic Sciences Epigenomics Ag Eurofins Genomics Everly Health Inc. Exact Sciences Corp. Exopert Exosomics Inc. Ezlife Bio Fabric Genomics Inc. F. Hoffmann-La Roche Ltd Fluxion Biosciences Inc. Freenome Holdings Inc. Fulgent Genetics Full Genomes Corp. Gene By Gene Ltd. Genedx Llc Geneseq Biosciences Genomoncology Llc Genosaber Grail Inc. Guardant Health Helio Genomics Helix Inc. Htg Molecular Diagnostics Inc. Imagia Canexia Health Incelldx Inc. Inex Innovate Private Ltd Inoviq Interpace Biosciences Inc. Invitae Corp. Invivoscribe Inc. Jabrehoo Med Tech Co. Ltd. Jbs Science Jumpcode Genomics Koninklijke Philips Labgenomics Lucence Health Macrogen Mapmygenome Mdxhealth Inc. Medgenome Medicover Genetics Merck Kgaa Micareo Rare Cell Diagnostics Micronoma Inc. Mir Scientific Mutantdx Myriad Genetics Inc. Nanostring Technologies Inc. Natera Inc. Nebula Genomics Neogenomics Laboratories New England Biolabs New Horizon Health Ltd. Novigenix Novogene Co. Ltd. Nrichdx Inc. Nuprobe Inc. Nx Prenatal Inc. Oncimmune Holdings Plc Oncocyte Corp. Oncodna Opko Health Orchid Oxford Nanopore Technologies Ltd. Pangaea Oncology Personal Genome Diagnostics Inc. Personalis Inc. Phase Scientific Pieriandx Predicine Prenetics Group Qcdx Llc Quantapore Quantgene Inc. Quantumdx Quest Diagnostics Rarecells Inc. Ravgen Real Time Genomics Resolution Bioscience Inc. Saga Diagnostics Sano Genetics Screencell Seekin Inc. Sequencing.Com Seven Bridges Genomics Inc. Single Technologies Smartcatch Strand Strata Oncology Syapse Inc. Sysmex Inostics Takara Bio Inc. Telexos Gmbh Twinstrand Biosciences Inc. Twist Bioscience Unchained Labs Universal Dx Vela Diagnostics Veracyte Volitionrx Vortex Biosciences Yourgene Health Yikon Genomics For more information about this report visit https://www.researchandmarkets.com/r/tklgxp About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

India's Orchid Pharma has gained a sublicense agreement to manufacture GSK and Shionogi's cefiderocol as part of a global effort to expand antibiotic access worldwide. Orchid Pharma, a subsidiary of India’s Dhanuka Labs, has gained a sublicense to manufacture the antibiotic cefiderocol from GSK and Shionogi as part of an effort to expand access worldwide.  Cefiderocol is used to treat certain Gram-negative bacterial infections that may be resistant to other antibiotics. The drug was approved by the FDA in 2019 and the European Medicines Agency in 2020, and it's listed on the World Health Organization’s (WHO) Model List of Essential Medicines. Also collaborating in the access effort are the the Global Antibiotic Research and Development Partnership and the Clinton Health Access Initiative, according to Shionogi's Tuesday release. The groups, which launched their effort in 2022, are focused on providing the antibiotic to low- and middle-income countries. “Our decades-long expertise in cephalosporins will be advantageous in manufacturing affordable and quality-assured cefiderocol,” Manish Dhanuka, managing director of Orchid Pharma, said in the release. “This will address the unmet needs of patients across low- and middle-income countries where antimicrobial resistance is spreading.”  As part of the agreement, Orchid must submit the product to the WHO medicines pre-qualification program. Products listed with the program are eligible for a collaborative procedure for accelerated registration, reducing the time for national regulatory approvals to 90 days in participating countries. At least 1.27 million deaths were attributed to antimicrobial resistance (AMR) in 2019, according to a paper published in The Lancet. The WHO estimates that if no action is taken, more than 10 million lives a year could be at risk of AMR by 2050. GSK collaborated with Shionogi on the development of cefiderocol, the Japanese drugmaker said. The British pharma giant is foregoing its royalties from sales on the medicine in low- and middle-income countries, Shionogi added.