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Next Hurdles For COVID-19 Vaccine Development: Selecting Endpoints, Getting Enough Subjects

 
• By Brenda Sandburg

US FDA's Peter Marks and industry execs discuss challenges in moving candidate vaccines to Phase II/III trials, including international regulatory alignment on clinical endpoints and other issues. J&J's Paul Stoffels says it is going to be a 'Herculean task' to conduct placebo-controlled studies in 30,000 to 100,000 people.

COVID-19 Vaccine. Corona Virus SARS-CoV-2, 2019 nCoV virus destruction. A vaccine against coronavirus disease 2019. Breakthrough in the Creating of a COVID-19 Vaccine.
COVID-19 vaccine candidates face new challenges as they move into Phase 2/3 trials

As COVID-19 vaccine candidates move into pivotal trials, developers and regulators are confronting new challenges, from getting a sufficient number of participants, to determining what will be needed to demonstrate safety and efficacy and how to deal with special populations.

The US FDA's Peter Marks, director of the Center for Biologics Evaluation and Research, and executives from companies developing COVID-19...

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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

 
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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.