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Abbott Mass Distributes Rapid COVID-19 Tests, Offers App So Consumers Can Display Test Results

The scope of the need for COVID-19 tests in the US is seen in Abbott Laboratories Ltd’s announcement of distributing 150m through the Department of Health and Human ..... see more

Source : 'HBW Insight'

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International Sales Reps’ COVID-19 Claims Bring Problems Home For US Supplement Direct Seller

A US direct selling firm’s statement that it will ask international sales representatives to pull fraudulent claims for dietary supplements to treat COVID-19 isn’t sufficient to assuage an industry self-regulation ..... see more

Source : 'HBW Insight'

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Pandemic Driving Stress In Consumers? DuPont Has A Probiotic Strain For That

Dupont Nutrition & Biosciences is rolling out its first probiotic ingredient for brain health in response to growing demand for strains that help manage psychological response to perceived stress, a ..... see more

Source : 'HBW Insight'

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Biden Vaccination Plan Would Grow Domestic Manufacturing Base

President-Elect Joe Biden included an expansion of domestic manufacturing in his proposal to deal with the coronavirus pandemic and ramp up US vaccination efforts.Dubbed the American Rescue Plan, the $1.9tn ..... see more

Source : 'The Pink Sheet'

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Lagging COVID Antibody Uptake Continues To Worry US Government

Two months after the coronavirus treatments were granted emergency use authorizations, uptake of Eli Lilly and Company and Regeneron Pharmaceuticals, Inc.’s COVID-19 monoclonal antibodies in the ..... see more

Source : 'The Pink Sheet'

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FDA’s COVID-19 Pandemic Plan Calls For Ongoing Clinical Trial Innovation

A continued focus on innovation in clinical trials is among the steps the US Food and Drug Administration could take to improve its response to the COVID-19 pandemic and future ..... see more

Source : 'The Pink Sheet'

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Coronavirus Notebook: EU To Buy 30 Million Doses Of Valneva Vaccine, Russia To Issue Compulsory License For Remdesivir

This week the European Commission announced that it had concluded exploratory talks with Valneva SE on an advance purchase agreement for 30 million doses of the French firm’s coronavirus ..... see more

Source : 'The Pink Sheet'

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Woodcock To Be Acting US FDA Commissioner, Leaving Agency in Stable, Capable Hands

Janet Woodcock will take over as acting commissioner of the US Food and Drug Administration upon Stephen Hahn’s departure on 20 January following the inauguration of President-elect Joe Biden, leaving the ..... see more

Source : 'The Pink Sheet'

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Will COVID-19 Drive The Decline Of International Reference Pricing?

The COVID-19 pandemic has shone a spotlight on the importance of equitable access to medicines and vaccines as well as flaws of international reference pricing (IRP) systems, which can price ..... see more

Source : 'The Pink Sheet'

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Adolescent Recruitment For COVID-19 Vaccine Trials Is Worry For Operation Warp Speed

Adult coronavirus vaccine clinical trial enrollment may continue moving at a brisk pace, but pediatric trials are recruiting more slowly, which could delay indication expansion.The search for pediatric patients concerns ..... see more

Source : 'The Pink Sheet'

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Permanent Vaccine Facility Should Be On Standby For Future Pandemics, Moncef Slaoui Says

Moncef Slaoui, the outgoing scientific advisor to Operation Warp Speed, says the quest to rapidly develop a COVID-19 vaccine has shown the need to have a permanent dedicated facility available ..... see more

Source : 'The Pink Sheet'

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FDA Suspends Premarket Notification Requirement For 7 Devices; 84 More Under Consideration

The US Food and Drug Administration will no longer require premarket notifications for seven low-risk medical devices, and may stop requiring them for 83 more moderate-risk devices and an unclassified ..... see more

Source : Medtech Insight

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Woodcock To Be Acting US FDA Commissioner, Leaving Agency in Stable, Capable Hands

Janet Woodcock will take over as acting commissioner of the US Food and Drug Administration upon Stephen Hahn’s departure on 20 January following the inauguration of President-elect Joe Biden, leaving the ..... see more

Source : Medtech Insight

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Preparedness, Policy And Patients – Learning From The Pandemic

Notwithstanding COVID-19, existing infectious diseases wreak significant health, social and economic havoc across the world each year (see Exhibit 1).According to a recent analysis by the National Bureau of Economic ..... see more

Source : IN VIVO

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FDA Commissioner Hahn To Seek Public Health Leadership Post To Work On COVID-19 Issues Next

Outgoing US Food and Drug Administration commissioner Stephen Hahn has signaled that he wants to focus on public health issues in his next career, and continue to address the types ..... see more

Source : Medtech Insight

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Don’t Write Actemra Off Yet: Roche Drug Found To Be ‘Lifesaving’ In COVID-19

Patients admitted to intensive care in the UK with severe COVID-19 will receive Roche Holding AG’s Actemra/RoActemra (tocilizumab) after an international trial found the drug could cut the ..... see more

Source : 'Scrip Intelligence'

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Pink Sheet Podcast: Pharma Gets Democratic Senate, Slow COVID-19 Vaccinations, 2020 CDER Approvals

Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith, Executive Editor Nielsen Hobbs and Senior Editor Cathy Kelly discuss the potential effects of the now Democrat-controlled Senate on pharma following ..... see more

Source : 'The Pink Sheet'

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EU Approval Of Oxford/AstraZeneca COVID-19 Vaccine Expected By End Of January

An EU decision on approving the Oxford University/AstraZeneca PLC COVID-19 may come by the end of this month. The European Medicines Agency expects AstraZeneca to apply for the ..... see more

Source : 'The Pink Sheet'