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Roche donates additional medicines and diagnostics for Ukraine

The Pharma Data

Roche today announced the donation of additional medicines and diagnostics to Ukraine. Beyond the already communicated 150,000 packs of an antibiotic medicine the new donation includes another 4,600 packs of specialized medicines for the treatment of influenza, rheumatoid arthritis, SMA and various cancers.

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It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

FDA Law Blog

Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

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Roche launches cobas pure integrated solutions analyser to help simplify operations in small to medium sized labs

The Pharma Data

Standardisation enables labs to do more work on fewer instruments, through consolidation of workflows, systems and reagents. cobas® pure integrated solutions brings together three diagnostic technologies 1 on a single platform to optimise space and resources in small to medium laboratory settings.

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Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern

The Pharma Data

3, and Delta ([link] About TIB Molbiol TIB Molbiol is a subsidiary of Roche Diagnostics that has supplied the global market with reagents for research and medical diagnostics for over 30 years. Roche and its subsidiary, Tib Molbiol, confirm that it has tests for research use that identify the SARS-CoV-2 subvariants of concern, Omicron: BA.1,

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Transitioning Between Academia and Industry: Advice from Leading Scientists That Made the Switch

XTalks

Leaving academia for industry is a route that academic scientists and professors did not traditionally pursue in the past due to perceived differences in skillsets, experiences and even associated stigmas. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments.

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Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

The Pharma Data

The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications.