Business Insights: Page 5

ProciseDx receives FDA de novo authorization for therapeutic drug monitoring tests
ProciseDx has received U.S. Food and Drug Administrtion (FDA) de novo marketing authorization for its point-of-care tests for monitoring levels of infliximab and adalimumab in patients being treated for inflammatory bowel diseases.
October 5, 2023
Fda Button Social
Genomic Health to pay $32.5M to settle False Claims Act allegations
Genomic Health, a subsidiary of Exact Sciences, has agreed to pay $32.5 million to settle allegations by the U.S. Department of Justice that it violated the False Claims Act by engaging in a scheme to improperly bill Medicare for laboratory tests.
October 4, 2023
Gavel Money Social
FDA issues EUAs for 2 POC COVID-19 tests
The U.S. Food and Drug Administration (FDA) granted emergency use authorizations (EUAs) for two separate point-of-care (POC) assays for SARS-CoV-2 developed by Tangen Biosciences and SD Biosensor.
October 4, 2023
3d Closeup Coronavirus Social
Abcam founder urges shareholders to reject $5.7B sale to Danaher
A founder of leading U.K. life sciences company Abcam has urged shareholders to reject a 4.5 billion pound ($5.7 billion) takeover bid by science and technology firm Danaher Corporation.
October 4, 2023
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Investors acquire Novarum DX subsidiary from BBI Solutions
A group of investors have announced that they have finalized a deal to acquire diagnostics software company Novarum DX from U.K.-based BBI Solutions.
October 3, 2023
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Thermo Fisher receives FDA clearance for neuroendocrine tumor assay
Thermo Fisher has received clearance from the U.S. Food and Drug Administration (FDA) for its Brahms chromogranin A (CgA) II Kryptor test, a CgA immunoassay for assessing tumor progression in gastroenteropancreatic neuroendocrine tumor patients.
October 2, 2023
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Labs and manufacturers face challenges with rollout of IVDR
Laboratories and medical device manufacturers have revealed how they face technical and workload challenges in gearing up to comply with stringent new European Union regulations.
October 2, 2023
Regulation Wheel Social
Harbinger Health raises $140M in series B funding
Biotech company Harbinger Health has raised $140 million in a series B funding round.
September 29, 2023
Artificial Intelligence Drug Design Funding Social
Day Zero Diagnostics to use $16M in funding to improve management of antibiotic-resistant infections
Day Zero Diagnostics recently raised $16 million to fund the application of whole-genome sequencing and artificial intelligence to antibiotic-resistant infections, facilitating the firm’s goal of changing how infectious diseases are diagnosed.
September 28, 2023
Dna Sequencing2
U.S. Attorney’s Office wins $370M judgment in Medicare fraud case
The U.S. Attorney's Office for the Middle District of Florida won a $370 million default judgment against a Kentucky lab owner and his businesses for a lab testing scheme intended to defraud Medicare.
September 28, 2023
Gavel Money Social
Ginkgo Bioworks, Pfizer collaborate on RNA-based therapeutics
Cell engineering company Ginkgo Bioworks has entered into an agreement with Pfizer to discover and develop RNA-based drug candidates.
September 28, 2023
Rna Strand Social
Thermo Fisher Scientific prepared to expand its work at manufacturing facility
Thermo Fisher Scientific executives voiced hopes for expanding work to help combat diseases at its giant $180 million viral vector manufacturing site in Plainville, MA.
September 27, 2023
Manufacturing Facility Process Social
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