Coronavirus Update: R&D Starts, Product Delays, Continuing Collaboration

In addition to our daily in-depth coverage of key events relating to the coronavirus pandemic, we’re bringing you a periodic round-up of other significant developments. 

The world health organization WHO declares an international emergency in connection with the outbreak of new pneumonia in China caused by the coronavirus 2019-nCoV virus
The coronavirus is continuing its spread • Source: Shutterstock

During the week of 23-27 March, the Gates Foundation announced a drug-hunting initiative; the UK MHRA closed its London offices, delayed regulatory submissions and launches; advances were seen in the search for new drugs and vaccines to help combat the disease; conferences went virtual… and there have been some stirring words from Regeneron’s George Yancopoulos.

A consortium of life sciences companies including leading pharma firms has announced a collaboration to speed up the development, manufacture...

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Learn what's happening at the US FDA. On the go.

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EU Biosimilar Filings, Opinions And Approvals

 
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<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>

Stealth’s Elamipretide: Efficacy In Barth Syndrome Not Shown, US FDA Says

 
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Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.

New EU Approvals

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

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COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Nancy Tests New Podcast Template

 

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
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To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.