Melissa Busch

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Mergers & Acquisitions
$16.5B CDMO deal unhindered by role in broader pharma supply chain
Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.
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Compliance and Regulation
Texas lab owner accused of $79M RPP fraud scheme
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FDA Warning Letter
FDA sounds bacteria alarms over CGMP violations in Maine
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Research and Development
Revvity broadens work in newborn testing for NHS England
Body composition in patients treated with Ozempic
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Body composition in patients treated with Ozempic
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$16.5B CDMO deal unhindered by role in broader pharma supply chain
By Liz Carey
Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.
December 11, 2024
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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
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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
Fda Logo V2 Social
Revvity broadens work in newborn testing for NHS England
By LabPulse.com staff writers
Revvity, formerly PerkinElmer, will expand its work with Genomics England to continue the Generation Project.
November 20, 2024
Baby Infant Mom Closeup Social
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
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AMP reviews pitfalls of NGS testing for SARS-CoV-2
By Liz Carey
Document offers key pre-analytical, analytical, and post-analytical considerations to help improve NGS-based surveillance programs.
November 15, 2024
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FDA fall IVD roundtable avoids LDT questions
By Liz Carey
In addition, CAP LDT webinar offers beginning guide for phase one compliance.
November 12, 2024
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Lucy Letby murder case flags immunoassays as unreliable for medical evidence
By Liz Carey
At least one pathologist has said it was wrong for scientists representing Liverpool Clinical Laboratories to insist insulin poisoning was the only explanation in a series of high-profile newborn deaths in the U.K., The Telegraph reported.
October 28, 2024
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Digital pathology rollouts race for proof-of-concept at national level
By Liz Carey
U.K. invests in clinical trial security while Australia's health minister issues powerful ultimatum.
October 29, 2024
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Caris Life Sciences embarks on 10K-sample breast cancer biomarker analysis project
By LabPulse.com staff writers
Caris will perform comprehensive molecular characterization of TAILORx tissue samples.
October 25, 2024
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ASCLS seeks support for med lab personnel act
By LabPulse.com staff writers
The proposed legislation includes loan repayment provisions and requires $25 million in the first year.
October 25, 2024
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Pathology groups' antitrust legal fight heats up
By LabPulse.com staff writers
A lawsuit in which Iowa pathologists are suing their former colleagues is escalating, with one side accusing the other of attempting to maintain a monopoly at the expense of patients.
October 24, 2024
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