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How US FDA Explained The Difference Between Approved And EUA Pfizer/BioNTech COVID-19 Vaccine

 
• By Derrick Gingery

When Comirnaty was approved in 2021, the product in the vials was identical, but the agency still had to state that legally they were different without confusing people.

Same but different
The approved Pfizer-BioNTech vaccine, Comirnaty, is not legally the same as the product available under emergency use authorization, even though the products are interchangeable. • Source: Shutterstock

The BLA review of Pfizer Inc./BioNTech SE’s COVID-19 vaccine Comirnaty raised a regulatory question that was easy to answer, but difficult to explain.

In late August 2021, Comirnaty was about to receive full approval for use in adults 16 and older. But the...

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The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

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Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA Meeting Drought Ends … With A Vengeance

 
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• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
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New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.