Compliance and Regulation: Page 4

Jury awards Guardant nearly $293M in lawsuit against Natera

By LabPulse.com staff writers

A federal jury in the U.S. District Court for the Northern District of California ruled in favor of Guardant Health in a lawsuit the company filed against Natera in May 2021.

November 26, 2024

Google releases open version of health AI developer platform

By LabPulse.com staff writers

Tool supports medical AI imaging applications in pathology (Path Foundation), chest x-ray (CXR Foundation), and dermatology (Derm Foundation).

November 26, 2024

Vyriad, Novartis to collaborate on CAR-T cell therapies

By LabPulse.com staff writers

Clinical-stage biotech firm Vyriad has entered into a strategic partnership with Novartis to discover and develop chimeric antigen receptor (CAR) T-cell therapies.

November 22, 2024

Precision for Medicine partners with Agena Bioscience to fill NGS testing gaps

By LabPulse.com staff writers

Partnership addresses insufficient sample quality in next-generation sequencing (NGS) testing.

November 20, 2024

Texas lab owner accused of $79M RPP fraud scheme

By LabPulse.com staff writers

The DOJ implicated a Texas clinical laboratory owner and operator in respiratory pathogen panel testing fraud scheme.

November 25, 2024

Digital pathology companies signal shift in France

By LabPulse.com staff writers

The announcement from France follows a similar one in Belgium involving academic hospital UZ Leuven moving to enterprise imaging with a focus on the digital pathology module, according to Sectra.

November 25, 2024

Labcorp completes lab asset acquisition, names new CFO

By LabPulse.com staff writers

Labcorp has completed its acquisition of the molecular testing site and other assets of an independent clinical laboratory in Birmingham, AL.

November 20, 2024

FDA sounds bacteria alarms over CGMP violations in Maine

By Liz Carey

Tom's troubles highlight the importance of being inspection-ready.

November 21, 2024

Proscia to offer Owkin's CRC test through platform

By LabPulse.com staff writers

Digital pathology firm Proscia and artificial intelligence biotech company Owkin will collaborate to make Owkin's colorectal cancer (CRC) diagnostic test available through Proscia's digital pathology software platform.

November 20, 2024

Large language models tapped for speeding up clinical trial enrollment in U.S.

By Liz Carey

Meanwhile, the FDA envisions integrating more clinical trial activities into local healthcare facilities, roaming mobile research units, and through at-home lab testing kits.

November 19, 2024

Roche gets CE Mark for ovarian cancer CDx test

By LabPulse.com staff writers

Roche has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its companion diagnostic (CDx) test, which is designed to aid in identifying ovarian cancer patients eligible for targeted treatment with Abbvie's Elahere.

November 19, 2024

Vesalius, GSK announce strategic alliance on neurodegenerative disease treatments

By LabPulse.com staff writers

Biotech firm Vesalius Therapeutics announced a strategic collaboration with GSK aimed at the discovery and development of therapeutics for Parkinson's disease and another undisclosed neurodegenerative disease.

November 15, 2024

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