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Pandemic Perspectives: Paul Offit On COVID-19 Vaccine Worries, Country’s Worst Biological Disaster, And What Lies Ahead

 
• By Brenda Sandburg

The prominent virologist and vaccine expert talks to the Pink Sheet about how COVID-19 vaccines could change future research, the ‘Rosetta Stone’ of the polio vaccine tragedy, and the 26-year effort to create a rotavirus vaccine.

Paul Offit
Paul Offit on COVID-19 vaccine development and its links to past pharma achievements • Source: Informa Pharma Intelligence/Shutterstock

In his biography of renowned vaccinologist Maurice Hilleman, Paul Offit describes eight doors opened by previous scientific discoveries that enabled Hilleman to develop the mumps vaccine. He now sees the opening of another door with the creation of COVID-19 vaccines: the administration of vaccines to pregnant women.

Pandemic Perspectives

One year on from the World Health Organization declaring COVID-19 a global pandemic on 11 March 2020, editors across Informa Pharma Intelligence publications are taking a closer look...

Pfizer Inc./BioNTech SE and Moderna, Inc. excluded pregnant women from their COVID-19 vaccine clinical trials, as is always done in vaccine trials. And given the lack of...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

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

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.