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Apr 8, 2020

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Astellas and Poseida to collaborate on oncology cell therapies
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FDA said no to proficiency testing for LDT quality
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Astellas and Poseida to collaborate on oncology cell therapies
By LabPulse.com staff writers
Poseida Therapeutics and Astellas, under its Xyphos Biosciences subsidiary, have initiated a research collaboration and licensing agreement to develop allogeneic cell therapy programs by combining their innovative cell therapy platforms and technologies.
May 2, 2024
T Cell Social
FDA said no to proficiency testing for LDT quality
By Liz Carey
Inferior tests can pass through proficiency testing, among ways PT falls short for test safety and effectiveness for intended purposes.
May 2, 2024
Regulation Wheel Social
Leica Biosystems, Sectra receive FDA 510(k) clearance for digital pathology system
By LabPulse.com staff writers
Leica Biosystems has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its Aperio GT 450 DX digital pathology system, in conjunction with Sectra's digital pathology software.
May 2, 2024
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FDA releases LDT final rule
By Liz Carey
The FDA announced its final rule on regulating laboratory developed tests (LDTs), also saying it will adopt targeted enforcement discretion for several categories of IVD LDTs manufactured by labs.
April 29, 2024
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GSK, Genomics PLC collaborate on polygenic risk score use for clinical trials
By LabPulse.com staff writers
Genomics PLC and biopharmaceutical firm GSK have established a collaboration aimed at assessing the potential for using polygenic risk scores in clinical trials.
May 1, 2024
Cell Gene Therapy Dna Social
Study: Age-related differences in nasal cells offer COVID-19 protection
By Matt Limb
Key differences in how the nasal cells of young and elderly people respond to the SARS-CoV-2 virus may explain why children typically experience milder symptoms of COVID-19, say researchers.
April 29, 2024
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Pillar Biosciences gets FDA approval for NGS solid tumor profiling test
By Matt Limb
Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.
April 26, 2024
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Immunovia announces positive results for next-gen pancreatic cancer test
By LabPulse.com staff writers
Diagnostics company Immunovia announced positive results for the newest generation of its pancreatic cancer test from a model-development study, announcing that the test achieved both its primary and secondary endpoints.
April 25, 2024
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Vertex to pay $25M upfront to scale cell manufacturing technology
By LabPulse.com staff writers
As part of the deal, Vertex was also willing to pay up to $215 million in milestones achieved in connection with the development of a scaled-up process for fully differentiated islet cells.
April 25, 2024
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Labcorp buys Invitae portfolio for $239M
By LabPulse.com staff writers
Labcorp was the winning bidder in the court-supervised auction of Invitae's assets, obtaining substantially all of the San Francisco-based company's business for $239 million in cash consideration with other noncash consideration.
April 26, 2024
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Bristol Myers Squibb to reduce workforce in restructuring plan
By LabPulse.com staff writers
As part of a restructuring plan intended to cut $1.5 billion in costs, Bristol Myers Squibb plans to cut about 6% of its workforce, according to the firm.
April 25, 2024
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U.K. Patents Court rules Bio-Techne patents invalid in infringement lawsuit
By LabPulse.com staff writers
The Patents Court of the High Court of England and Wales has ruled that two patents owned by Bio-Techne are invalid, rejecting a patent infringement lawsuit filed by Bio-Techne/ACD in the U.K. against Molecular Instruments.
April 24, 2024
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