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Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Gilead's Veklury (remdesivir) is the first and only drug approved by the US Food and Drug Administration for the treatment of COVID-19, although it is already widely used for treating ..... see more

Source : 'Scrip Intelligence'

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Coronavirus Update: Human Vaccine Challenge Study Gains UK Backing

The UK government is to provide funding of up to £10m ($12.95m) to what could be the world’s first human challenge study of COVID-19 vaccines, in which volunteers will be ..... see more

Source : 'Scrip Intelligence'

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As Pandemic Boosts Demand For Immunity Supplements, Dentovations Launches Self+ Line

For Dentovations Inc., hand sanitizers no longer are its only products in a category showing rapid sales growth driven by the COVID-19 pandemic. It recently launched Self+ Supplements as consumer demand ..... see more

Source : 'HBW Insight'

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Pink Sheet Podcast: The Big Vaccines Adcomm, AMAG Fights Makena Withdrawal

Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith, Senior Editor Sue Sutter and Executive Editor Nielsen Hobbs offer their take-aways from the 22 October Vaccines and Related Biological Products ..... see more

Source : 'The Pink Sheet'

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UK Authorizes Use Of Unlicensed Flu Vaccine

The UK government has given the go-ahead for the use of an unlicensed flu vaccine from Sanofi to help meet high demand for vaccination amid the coronavirus pandemic and the ..... see more

Source : 'The Pink Sheet'

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EU Prepares Ground For Deployment Of COVID-19 Vaccines

The European Commission is working on ways of fairly allocating future COVID-19 vaccines among EU member states and says plans are under way to establish enhanced safety monitoring for any ..... see more

Source : 'The Pink Sheet'

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US FDA Needs To Harmonize Postmarket Safety Plans For COVID Vaccines, CDC Advisors Urge

Harmonized safety endpoints and post-market protocols that can be deployed among multiple pharmacovigilance systems should be developed to enable faster identification and evaluation of safety signals with COVID-19 vaccines post-authorization ..... see more

Source : 'The Pink Sheet'

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Expediting The Expedited: How Rolling CMC Review Process Is Working For COVID-19 Vaccines

Rolling submissions of chemistry, manufacturing and controls information are playing a key role in accelerating regulatory reviews of COVID-19 vaccines and therapeutics to speeds never envisioned in the many acceleration ..... see more

Source : 'The Pink Sheet'

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COVID-19 Vaccines Blaze New Path In the History Of Vaccine Development

There have been astounding moments in the history of vaccine development. The first time someone was inoculated with a vaccine for smallpox, which led to the elimination of this most ..... see more

Source : 'The Pink Sheet'

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What Came Before COVID-19: Two Centuries Of Vaccine Development

Looking back over the past two centuries of vaccine development puts the development of COVID-19 vaccines in historical perspective and is a reminder of the tremendous advancements that have been ..... see more

Source : 'The Pink Sheet'

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Gene Therapy Approval Standards: Available Treatments Influence US FDA’s View On Durability

The US Food and Drug Administration’s view of the importance of durability for a gene therapy depends, in part, on the condition being treated and the existence of other approved ..... see more

Source : 'The Pink Sheet'

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COVID-19 Vaccine EUA Process Compresses Advisory Committee Prep Too

The US Food and Drug Administration expects coronavirus vaccine sponsors to begin preparing for an advisory committee meeting before their emergency use authorization request is even filed in order to ..... see more

Source : 'The Pink Sheet'

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After EUA Approval, COVID Vaccine Sponsors Need Plans For Continuing Trials

The US Food and Drug Administration wants COVID-19 vaccine developers to have plans for ensuring their clinical trials will continue after an emergency use authorization is granted and that product ..... see more

Source : 'The Pink Sheet'

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COVID Vaccine Postmarket Monitoring Will Depend On Which Adverse Events US FDA Wants To Watch

The US Food and Drug Administration has the unenviable task of picking the most important adverse events to track once coronavirus vaccination begins.Agency officials expect to monitor adverse event reports ..... see more

Source : 'The Pink Sheet'

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Europe Must Look Beyond Price To Secure Supply Chain

European health systems are jeopardizing efforts to strengthen the local supply chain and bolster manufacturing in the region by opting for the lowest-cost generics rather than considering important non-price factors, ..... see more

Source : 'Generics Bulletin'

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APACMed: Johnson & Johnson On Using ‘Big’ For Good In The COVID-19 Challenge

The worldwide chair of medical devices at Johnson & Johnson, Ashley McEvoy, was the first keynote speaker at APACMed’s 2020 virtual annual conference, an event whose content and ..... see more

Source : Medtech Insight

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Pfizer/BioNTech COVID-19 Vaccine Will Miss US Election, Bourla Clarifies

With the US presidential election nearing, Pfizer Inc. is making clear that its COVID-19 vaccine will not be submitted for emergency use authorization until later. CEO Albert Bourla ..... see more

Source : 'Scrip Intelligence'

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Coronavirus Update: J&J Pauses COVID-19 Vaccine Trial After Unexplained Illness

Johnson & Johnson has paused all trials of its COVID-19 vaccine after a single participant developed an unexplained illness.The company announced the temporary pause of further dosing in all its ..... see more

Source : 'Scrip Intelligence'

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US FDA Has Done Over 200 ‘Mission Critical’ Inspections During COVID

The US Food & Drug Administration has conducted “more than 200 mission critical” inspections since the COVID-19 disruptions began in March, Associate Commissioner for Regulatory Affairs Judy McMeekin said during ..... see more

Source : 'The Pink Sheet'