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8/6/2020

A 354-patient study shows that the FirstSightCRC test can detect colorectal cancer with 100% sensitivity and 90% specificity as well as detect advanced adenomas with 75.5% sensitivity.

8/6/2020

European regulators have given CE mark approval to NeuMoDx Molecular for its Quantitative BK virus assay that will help health care providers monitor infection in critical organ transplant patients.

8/6/2020

European regulators have given CE mark approval to Endologix for its ALTO abdominal stent-graft system that is used in the repair of endovascular aneurysms.

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FDAnews
8/6/2020

The FDA has given clearance to Life Spine for its Plateau-A Ti anterior lumbar spacer system that is used during anterior fusion procedures.

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MassDevice (Boston)
8/6/2020

The FDA has given 510(k) clearance to Surmodics for its Sublime Radial Access 0.014 Rapid Exchange Percutaneous Transluminal Angioplasty Dilation Catheter.

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SurModics
8/6/2020

The FDA has released final guidance offering details on how drugmakers and sponsors should prepare and submit pediatric study plans. According to the guidance, sponsors required to submit initial pediatric study plans must do so within 60 calendar days after the end-of-Phase 2 meeting, or at a time agreed on by the company and the FDA.

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Regulatory Focus
8/6/2020

Eli Lilly and Co. has launched a late-stage trial to evaluate whether its investigational antibody drug can prevent coronavirus infections or COVID-19 in staff or residents of nursing homes exposed to someone with COVID-19. The novel trial will be conducted with the help of the NIH through its COVID-19 Prevention Network.

8/6/2020

The Svalbard Global Seed Vault in Germany is launching a 100-year seed experiment that will involve storage of experimental seed samples from five gene banks in liquid nitrogen at minus 196 Celsius to impede the ageing process for barley, cabbage, lettuce, pea and wheat. "This experiment is one of its kind. It will provide future generations with valuable information about seed viability and more precise knowledge of how often seeds need to be regenerated," said Asmund Asdal, seed vault coordinator for Nordic Genetic Resource Center, the gene bank managing the project.

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Seed World
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Svalbard Global Seed Vault
8/6/2020

Pharmaceutical companies will benefit from a modular approach to labeling that creates blocks of content that can be reworked to comply with changing regulatory requirements and other needs, writes David Bennett. Such an approach enables life sciences companies to react in real time to regulation and quality standard changes, while creating a single source of truth.

8/6/2020

Patients have established routines and views when it comes to taking medicines, and the pharmaceutical industry must keep these in mind during the development process, writes Sven Stegemann. The FDA's "Patient-Focused Drug Development" guidelines were designed to help pharmaceutical companies account for patient perspectives in their work -- critical to ensuring that patients themselves benefit from medication.

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