Business Insights: Page 2

Roche, Lilly Alzheimer's blood test granted FDA breakthrough device designation
By LabPulse.com staff writers
The Alzheimer's blood test developed through a collaboration between Roche and Lilly has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA).
April 11, 2024
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European Commission approves Illumina's plan to divest Grail
By LabPulse.com staff writers
The European Commission has approved Illumina's plan to divest multicancer early detection test maker Grail under the European Union Merger Regulation adopted by the EC in October 2023.
April 12, 2024
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Roche's breast cancer CDx receives CE Mark
By LabPulse.com staff writers
Roche has received the CE Mark for the first companion diagnostic (CDx) test to identify patients with HER2-low metastatic breast cancer who may be eligible for treatment with Enhertu.
April 10, 2024
Breast Mammo Social
Seaport Therapeutics launches with $100M financing round
By LabPulse.com staff writers
Clinical-stage biopharmaceutical company Seaport Therapeutics launched with the announcement of the closing of a $100 million oversubscribed series A financing round.
April 9, 2024
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Johnson & Johnson to acquire Shockwave Medical
By LabPulse.com staff writers
Johnson & Johnson will acquire Shockwave Medical, expanding Johnson & Johnson MedTech's position in the growing medtech market for cardiovascular intervention.
April 8, 2024
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Prenosis gets FDA authorization for AI-based sepsis diagnostic tool
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization to artificial intelligence (AI) healthcare firm Prenosis' AI-based ImmunoScore sepsis risk-assessment software.
April 8, 2024
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Binx Health closes $65M financing round
By LabPulse.com staff writers
Binx Health announced that it successfully closed a $65 million series F financing round.
April 5, 2024
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Basilea gets FDA approval for antibiotic
By LabPulse.com staff writers
Swiss pharmaceutical manufacturer Basilea has received U.S. Food and Drug Administration (FDA) approval for its antibiotic Zevtera (ceftobiprole) for three different types of infections.
April 4, 2024
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Biofidelity completes $24M financing round
By LabPulse.com staff writers
Genomics company Biofidelity announced that it has completed a financing round totaling $24 million, bringing the firm’s total funding since its founding in 2019 to $60 million.
April 3, 2024
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Magritek enhances benchtop NMR instruments
By LabPulse.com staff writers
Nuclear magnetic resonance software builds capabilities for labs looking for synthetic drugs and new psychoactive substances, using benchtop NMR instruments.
March 29, 2024
Drug Testing Counterfeit Social
Florida man pleads guilty in $4.6 million kickback scheme
By LabPulse.com staff writers
A Tampa, FL man pleaded guilty for his role in a scheme to receive kickbacks and bribes from labs in exchange for referrals of patient DNA samples and genetic tests, according to the U.S. Attorney's Office for the District of New Jersey.
March 29, 2024
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BioMérieux gets FDA 510(k) clearance, CLIA waiver approval for panel
By LabPulse.com staff writers
BioMérieux's Biofire Spotfire Respiratory/Sore Throat Panel has received dual FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.
March 27, 2024
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