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12/2/2020

An Operation Warp Speed document sent to governors estimates that initial shipments of Pfizer and BioNTech's COVID-19 vaccine will be delivered Dec. 15, to be followed by Moderna's vaccine Dec. 22, but these distribution dates are contingent on the FDA's decision to grant emergency authorization for both vaccines. According to the document, an estimated 18 million doses of Moderna's vaccine and 22.5 million doses of Pfizer/BioNTech's vaccine will be manufactured this month.

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CNN
12/2/2020

The CDC soon will release new guidelines reducing the recommended quarantine period for people who have come in contact with COVID-19-positive individuals to between seven and 10 days, down from 14 days under current recommendations, according to senior administration officials. These "close contacts" of infected individuals would be able to end their quarantine in as early as seven days if they get a negative COVID-19 test result.

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The Associated Press, CNN
12/2/2020

Salient Bio has released a fast, low-cost, robotics-driven COVID-19 PCR mass testing platform that has 100% sensitivity and 98% specificity.

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BioWorld MedTech
12/2/2020

Genetworx Labs has released a combo PCR test that can detect SARS-CoV-2, influenza A and B and respiratory syncytial virus. "With this new combination test, healthcare providers can provide an accurate diagnosis to patients and treat them with the appropriate measures," said Genetworx Labs CEO William Miller.

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MassDevice (Boston)
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William Miller
12/2/2020

HB27, a humanized form of a monoclonal antibody identified in mice inoculated with SARS-CoV-2, blocks the coronavirus from attaching to cells' ACE2 receptors and prevents membrane fusion, both of which are important mechanisms of infection, researchers reported on the preprint server bioRxiv. The antibody caused no obvious adverse effects in rhesus monkeys, even at high doses, prevented and treated infections in transgenic mice, and reduced viral load in the lungs and trachea of infected mice.

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News Medical
12/1/2020

Flu vaccine maker Seqirus uses its seasonal flu vaccines as practice runs to quickly produce other vaccines during an outbreak, says Russell Basser, who leads research and development at the Australian company. The company is supplying the MF59 adjuvant to the nonprofit Coalition for Epidemic Preparedness Innovations and The University of Queensland to help in the development of rapid response vaccines using a molecular clamp platform.

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Seqirus
12/1/2020

Using software as a service, which is software sold as a subscription, can accelerate changes to a business and its suppliers seamlessly, says Nick Pike of Vizibl. For pharmaceutical companies, software as a service can also standardize environmental, social and governance objectives across supply chains to ease compliance, Pike says.

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SaaS
12/1/2020

Once a COVID-19 vaccine is produced, distribution and insurance payments will need to be tracked and monitored, write former FDA commissioners Scott Gottlieb and Mark McClellan. They suggest that the federal government set up a tracking system or use existing Medicare systems on the state level.

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Scott Gottlieb
12/1/2020

Early detection of acute kidney injury is key to preventing irreversible kidney damage and helping clinicians provide the appropriate management. Various AKI biomarker assays have been approved for clinical use in the last decade, but researchers continue to study and look for a better AKI biomarker that could quickly and specifically detect occurring kidney injury, inform treatment, predict prognosis and improve patient outcomes.

11/30/2020

The UK's National Health Service has launched a trial to evaluate Grail's Galleri blood test, which is said to be capable of detecting over 50 types of cancer. The assay checks for molecular changes and could help the agency meet the NHS Long Term Plan goal to increase early detection of cancer.