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Could This Be Pfizer’s Biggest Week At The US FDA For COVID Products?

 
• By Brenda Sandburg

With an EUA submission for its Paxlovid treatment pill and expected authorization for universal adult vaccine boosters, Pfizer is establishing a portfolio of COVID products that could be used well after the eventual lifting of the public health emergency.

Paxlovid
Pfizer seeks FDA emergerency use authorization of its COVID-19 pill • Source: Alamy

Less than two weeks after announcing interim results of a Phase II/III study of its COVID-19 oral antiviral Paxlovid, Pfizer Inc. filed an application for emergency use authorization with the US Food and Drug Administration on 16 November.

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EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
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EU Biosimilar Filings, Opinions And Approvals

 
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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.

US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
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Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
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Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
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Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.